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Trial record 82 of 199 for:    Protamine

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00139659
Recruitment Status : Completed
First Posted : August 31, 2005
Results First Posted : May 12, 2010
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Asthma
Diabetes Mellitus
Interventions Drug: Inhaled Insulin
Drug: Subcutaneous Insulin
Enrollment 288
Recruitment Details Subjects were recruited at 63 centers and participated in the study between 10 January 2003 and 22 October 2008.
Pre-assignment Details 544 subjects were screened for the study. Prior to randomization subjects completed a 3-week run-in period during which all subjects received subcutaneous insulin. Of 288 subjects randomized, only 286 received randomized treatment; one subject assigned to inhaled insulin received subcutaneous insulin, and 1 subject DC'd prior to treatment.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin. Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Period Title: Overall Study
Started 146 [1] 141 [2]
Completed 106 123
Not Completed 40 18
Reason Not Completed
Adverse Event             12             1
Lack of Efficacy             1             1
Lost to Follow-up             7             3
Reason not Specified             6             3
Withdrawal by Subject             14             10
[1]
1 subject randomized was DC'd prior to receiving inhaled insulin but received subcutaneous insulin
[2]
1 subject randomized DC'd before receiving subcutaneous insulin and is not included in # of subjects
Arm/Group Title Inhaled Insulin Subcutaneous Insulin Total
Hide Arm/Group Description Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin. Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin. Total of all reporting groups
Overall Number of Baseline Participants 146 141 287
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants 141 participants 287 participants
18-25 years 12 8 20
26-35 years 18 13 31
36-45 years 23 25 48
46-55 years 33 41 74
56-65 years 40 37 77
66-75 years 20 17 37
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 141 participants 287 participants
Female
97
  66.4%
91
  64.5%
188
  65.5%
Male
49
  33.6%
50
  35.5%
99
  34.5%
1.Primary Outcome
Title Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Annualized rates of change (slope throughout time from baseline to end of study[visit]) for forced expiratory volume in 1 second (FEV1) (liters per year [L/yr]) measured 30 minutes following the administration of albuterol.
Time Frame Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 117 127
Mean (Standard Error)
Unit of Measure: L/yr
-0.070  (0.020) -0.035  (0.019)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method longitudinal data analysis model
Comments Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.034
Confidence Interval 90%
-0.080 to 0.011
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.
2.Primary Outcome
Title Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)
Hide Description Annualized rates of change (slope throughout time from baseline to end of study[visit]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.
Time Frame Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set (PAS).
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 117 127
Mean (Standard Error)
Unit of Measure: ml/min/mmHg/yr
-0.776  (0.152) -0.273  (0.153)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Longitudinal data analysis model
Comments Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.503
Confidence Interval 90%
-0.858 to -0.148
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.216
Estimation Comments Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.
3.Primary Outcome
Title Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
Hide Description Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.
Time Frame Baseline through Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all subjects who were randomized, had a baseline post-albuterol pulmonary function test (PFT) measurement, and had at least two post-baseline, post-albuterol PFT measurements. LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=141, 139) 2.559  (0.771) 2.524  (0.742)
Week 1 (n=123, 125) -0.066  (0.150) -0.027  (0.126)
Week 2 (n=126, 115) -0.056  (0.150) -0.031  (0.128)
Week 3 (n=131, 119) -0.077  (0.185) -0.030  (0.130)
Week 4 (n=121, 129) -0.074  (0.161) -0.022  (0.155)
Week 6 (n=130, 135) -0.070  (0.248) -0.025  (0.146)
Week 12 (n=125, 129) -0.053  (0.212) -0.031  (0.182)
Week 18 (n=124, 125) -0.066  (0.226) -0.040  (0.165)
Week 26 (n=120, 128) -0.056  (0.175) -0.038  (0.184)
Week 39 (n=107, 124) -0.088  (0.191) -0.039  (0.194)
Week 52 (n=106, 112) -0.131  (0.259) -0.059  (0.234)
Week 52 LOCF (n=141, 139) -0.113  (0.261) -0.062  (0.225)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.039
Confidence Interval 90%
-0.079 to -0.000
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.029
Confidence Interval 90%
-0.068 to 0.010
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 90%
-0.084 to -0.006
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.046
Confidence Interval 90%
-0.085 to -0.007
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.046
Confidence Interval 90%
-0.085 to -0.007
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.023
Confidence Interval 90%
-0.063 to 0.017
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.021
Confidence Interval 90%
-0.062 to 0.020
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.014
Confidence Interval 90%
-0.055 to 0.027
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.042
Confidence Interval 90%
-0.085 to 0.000
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.026
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.065
Confidence Interval 90%
-0.109 to -0.022
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.050
Confidence Interval 90%
-0.097 to -0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)
Hide Description Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
Baseline (n=141, 139) 23.023  (5.914) 22.883  (6.079)
Week 1 (n=122, 124) -0.574  (1.392) -0.333  (1.405)
Week 2 (n=126, 112) -0.777  (1.631) -0.481  (1.290)
Week 3 (n=129, 118) -0.811  (1.244) -0.506  (1.388)
Week 4 (n=120, 128) -1.075  (1.425) -0.576  (1.397)
Week 6 (n=129, 135) -1.017  (1.633) -0.602  (1.488)
Week 12 (n=125, 125) -0.961  (1.738) -0.477  (1.588)
Week 18 (n=124, 123) -1.024  (1.774) -0.549  (1.601)
Week 26 (n=119, 127) -0.849  (1.914) -0.477  (1.706)
Week 39 (n=107, 123) -1.016  (1.649) -0.395  (1.767)
Week 52 (n=105, 110) -1.483  (1.944) -0.798  (1.967)
Week 52 LOCF (n=141, 139) -1.426  (1.856) -0.682  (1.958)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.279
Confidence Interval 90%
-0.606 to 0.048
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.199
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.336
Confidence Interval 90%
-0.661 to -0.011
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.198
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.384
Confidence Interval 90%
-0.707 to -0.061
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.196
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.516
Confidence Interval 90%
-0.842 to -0.191
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.198
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.474
Confidence Interval 90%
-0.797 to -0.152
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.196
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.533
Confidence Interval 90%
-0.866 to -0.200
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.202
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.509
Confidence Interval 90%
-0.845 to -0.174
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.204
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.412
Confidence Interval 90%
-0.749 to -0.076
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.204
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.707
Confidence Interval 90%
-1.056 to -0.358
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.212
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.680
Confidence Interval 90%
-1.040 to -0.320
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.219
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.765
Confidence Interval 90%
-1.116 to -0.415
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.212
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
Hide Description Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.
Time Frame Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Error)
Unit of Measure: liters
Baseline (141, 139) 2.435  (0.748) 2.412  (0.727)
Week 1 (123, 125) -0.057  (0.142) -0.035  (0.131)
Week 2 (n=127, 117) -0.065  (0.159) -0.034  (0.150)
Week 3 (n=130, 121) -0.067  (0.185) -0.044  (0.171)
Week 4 (n=123, 130) -0.076  (0.185) -0.037  (0.181)
Week 6 (n=130, 135) -0.059  (0.211) -0.034  (0.170)
Week 12 (n=125, 130) -0.067  (0.237) -0.032  (0.193)
Week 18 (n=125, 125) -0.063  (0.218) -0.042  (0.183)
Week 26 (n=120, 129) -0.058  (0.190) -0.043  (0.195)
Week 39 (n=108, 124) -0.076  (0.195) -0.044  (0.186)
Week 52 (n=106, 112) -0.136  (0.259) -0.056  (0.230)
Week 52 LOCF (n=141, 139) -0.119  (0.259) -0.058  (0.222)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.025
Confidence Interval 90%
-0.065 to 0.015
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.034
Confidence Interval 90%
-0.073 to 0.006
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.024
Confidence Interval 90%
-0.063 to 0.016
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.035
Confidence Interval 90%
-0.075 to 0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.027
Confidence Interval 90%
-0.067 to 0.012
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.033
Confidence Interval 90%
-0.073 to 0.008
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.018
Confidence Interval 90%
-0.059 to 0.023
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.010
Confidence Interval 90%
-0.052 to 0.031
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.025
Confidence Interval 90%
-0.068 to 0.017
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.026
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.073
Confidence Interval 90%
-0.117 to -0.029
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.061
Confidence Interval 90%
-0.108 to -0.015
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)
Hide Description Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: ml/min/mmHg
Baseline (n=141, 139) 23.034  (5.921) 22.911  (6.059)
Week 1 (n=123, 125) -0.749  (1.467) -0.452  (1.220)
Week 2 (n=126, 114) -0.835  (1.353) -0.456  (1.485)
Week 3 (n=128, 119) -0.855  (1.407) -0.556  (1.452)
Week 4 (n=122, 127) -1.120  (1.609) -0.648  (1.500)
Week 6 (n=129, 135) -1.169  (1.583) -0.669  (1.441)
Week 12 (n=124, 128) -1.018  (1.842) -0.725  (1.788)
Week 18 (n=123, 125) -0.906  (1.756) -0.646  (1.748)
Week 26 (n=117, 127) -0.945  (1.683) -0.561  (1.982)
Week 39 (n=106, 125) -0.821  (1.742) -0.550  (1.805)
Week 52 (n=105, 111) -1.699  (2.157) -0.911  (2.239)
Week 52 LOCF (n=141, 139) -1.557  (2.109) -0.785  (2.141)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.327
Confidence Interval 90%
-0.679 to 0.026
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.214
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.378
Confidence Interval 90%
-0.729 to -0.027
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.346
Confidence Interval 90%
-0.696 to 0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.496
Confidence Interval 90%
-0.847 to -0.145
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.610
Confidence Interval 90%
-0.960 to -0.260
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.360
Confidence Interval 90%
-0.721 to 0.001
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.219
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.291
Confidence Interval 90%
-0.655 to 0.073
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.221
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.420
Confidence Interval 90%
-0.788 to -0.052
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.224
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.337
Confidence Interval 90%
-0.717 to 0.042
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.231
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.789
Confidence Interval 90%
-1.181 to -0.397
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.238
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.786
Confidence Interval 90%
-1.178 to -0.393
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.238
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)
Hide Description Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.
Time Frame Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 130 133
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=130, 133) 2.449  (0.775) 2.403  (0.727)
Week 9 (n=111, 108) -0.038  (0.235) -0.028  (0.163)
Week 51 (n=103, 119) -0.078  (0.227) -0.017  (0.245)
Week 51 LOCF (n=130, 133) -0.068  (0.237) -0.018  (0.237)
8.Secondary Outcome
Title Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)
Hide Description Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.
Time Frame Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 128 131
Mean (Standard Deviation)
Unit of Measure: ml/min/mmHg
Baseline (n=128, 131) 22.836  (6.087) 22.718  (6.128)
Week 9 (n=109, 106) -1.130  (1.663) -0.663  (1.549)
Week 51 (n=102, 116) -1.156  (1.825) -0.630  (2.023)
Week 51 LOCF (n=128, 131) -1.185  (1.804) -0.533  (1.990)
9.Secondary Outcome
Title Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)
Hide Description Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=141, 139) 3.355  (0.963) 3.341  (0.918)
Week 1 (n=123, 125) -0.068  (0.181) -0.046  (0.134)
Week 2 (n=126, 115) -0.057  (0.190) -0.053  (0.169)
Week 3 (n=131, 119) -0.078  (0.205) -0.068  (0.174)
Week 4 (n=121, 129) -0.065  (0.193) -0.051  (0.176)
Week 6 (n=130, 135) -0.092  (0.287) -0.043  (0.173)
Week 12 (n=125, 129) -0.045  (0.222) -0.056  (0.190)
Week 18 (n=124, 125) -0.053  (0.225) -0.069  (0.179)
Week 26 (n=120, 128) -0.061  (0.215) -0.052  (0.186)
Week 39 (n=107, 124) -0.080  (0.209) -0.057  (0.213)
Week 52 (n=106, 112) -0.105  (0.288) -0.088  (0.259)
Week 52 LOCF (n=141, 139) -0.097  (0.278) -0.083  (0.247)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.021
Confidence Interval 90%
-0.066 to 0.023
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.000
Confidence Interval 90%
-0.044 to 0.044
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.012
Confidence Interval 90%
-0.056 to 0.032
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.004
Confidence Interval 90%
-0.048 to 0.041
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 90%
-0.089 to -0.001
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.010
Confidence Interval 90%
-0.035 to 0.056
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.018
Confidence Interval 90%
-0.028 to 0.064
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.005
Confidence Interval 90%
-0.051 to 0.041
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.022
Confidence Interval 90%
-0.070 to 0.026
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.029
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.015
Confidence Interval 90%
-0.064 to 0.034
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.030
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.015
Confidence Interval 90%
-0.067 to 0.037
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.031
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol
Hide Description Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: percent change in FEV1
Baseline (n=141, 139) 5.487  (5.163) 5.102  (6.416)
Week 1 (n=123, 125) -0.015  (5.452) 0.347  (5.429)
Week 2 (n=126, 115) 0.683  (5.984) 0.347  (6.354)
Week 3 (n=130, 119) -0.055  (6.082) 0.823  (5.449)
Week 4 (n=121, 129) 0.056  (6.361) 0.559  (5.733)
Week 6 (n=130, 135) -0.460  (5.480) 0.504  (6.350)
Week 12 (n=124, 129) 0.721  (5.972) -0.100  (6.783)
Week 18 (n=124, 125) -0.095  (5.909) 0.154  (7.649)
Week 26 (n=120, 128) -0.186  (5.624) 0.211  (5.080)
Week 39 (n=107, 124) -0.283  (5.368) 0.133  (5.089)
Week 52 (n=106, 112) 0.640  (5.338) -0.035  (6.156)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.632
Confidence Interval 90%
-1.778 to 0.514
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.697
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.020
Confidence Interval 90%
-1.079 to 1.120
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.668
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.582
Confidence Interval 90%
-0.535 to 1.700
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.679
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.054
Confidence Interval 90%
-1.184 to 1.077
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.687
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.535
Confidence Interval 90%
-1.677 to 0.608
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.694
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.905
Confidence Interval 90%
-2.014 to 0.203
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.674
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.212
Confidence Interval 90%
-0.899 to 1.323
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.675
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.044
Confidence Interval 90%
-1.080 to 1.169
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.683
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.240
Confidence Interval 90%
-1.382 to 0.902
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.694
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.503
Confidence Interval 90%
-1.673 to 0.668
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.711
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)
Hide Description Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value *100%.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Mean (Standard Deviation)
Unit of Measure: percentage of FEV1
Baseline (n=141, 139) 83.698  (14.096) 82.833  (15.219)
Week 1: % of Predicted Value (n=123, 125) 81.987  (14.441) 82.878  (15.438)
Week 2: % of Predicted Value (n=126, 115) 81.655  (13.985) 81.881  (15.017)
Week 3: % of Predicted Value (n=131, 119) 80.711  (13.854) 82.036  (15.354)
Week 4: % of Predicted Value (n=121, 129) 81.093  (15.145) 82.029  (14.914)
Week 6: % of Predicted Value (n=130, 135) 81.611  (14.553) 82.016  (15.509)
Week 12: % of Predicted Value (n=125, 129) 82.145  (13.885) 81.640  (14.673)
Week 18: % of Predicted Value (n=124, 125) 82.187  (14.405) 81.723  (14.505)
Week 26: % of Predicted Value (n=120, 128) 82.941  (14.291) 82.227  (14.305)
Week 39: % of Predicted Value (n=107, 124) 82.851  (14.447) 81.847  (14.794)
Week 52: % of Predicted Value (n=106, 112) 80.869  (14.934) 81.138  (14.461)
Week 52 LOCF: % of Predicted Value (n=141, 139) 80.136  (14.528) 80.687  (14.671)
Week 1: % Change from Baseline (n=123, 125) -2.682  (5.780) -1.238  (5.307)
Week 2: % Change from Baseline (n=126, 115) -2.355  (5.909) -1.142  (5.273)
Week 3: % Change from Baseline (n=131, 119) -2.943  (7.583) -1.057  (5.292)
Week 4: % Change from Baseline (n=121, 129) -3.063  (6.926) -0.833  (6.172)
Week 6: % Change from Baseline (n=130, 135) -2.559  (8.725) -0.957  (6.180)
Week 12: % Change from Baseline (n=125, 129) -1.975  (8.495) -1.226  (7.603)
Week 18: % Change from Baseline (n=124, 125) -2.437  (8.713) -1.247  (6.688)
Week 26: % Change from Baseline (n=120, 128) -2.006  (6.891) -1.189  (8.013)
Week 39: % Change from Baseline (n=107, 124) -3.144  (7.507) -1.466  (8.332)
Week 52: % Change from Baseline (n=106, 112) -4.777  (8.794) -2.002  (10.040)
Week 52 LOCF: % Change from Baseline (n=141, 139) -4.129  (9.673) -2.108  (9.652)
12.Secondary Outcome
Title Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin
Hide Description Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.
Time Frame Baseline, Week 9, Week 51
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 124 131
Mean (Standard Deviation)
Unit of Measure: liters
Baseline: 10 minutes (n=124, 131) -0.004  (0.085) 0.003  (0.086)
Week 9: 10 minutes (n=105, 106) -0.008  (0.130) 0.005  (0.111)
Week 51: 10 minutes (n=96, 113) 0.000  (0.113) 0.013  (0.104)
Baseline: 60 minutes (n=125, 131) -0.004  (0.120) 0.016  (0.130)
Week 9: 60 minutes (n=105, 105) 0.013  (0.113) 0.028  (0.137)
Week 51: 60 minutes (n=99, 112) 0.029  (0.139) 0.020  (0.123)
13.Secondary Outcome
Title Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)
Hide Description Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value *100%.
Time Frame Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS); LOCF: last observation carried forward.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 124 131
Mean (Standard Deviation)
Unit of Measure: percent
Baseline: 10 minutes (n=124, 131) 94.402  (6.532) 94.391  (6.168)
Week 9: 10 min.; % of Predicted Value (n=105, 106) 92.698  (9.187) 94.190  (7.190)
Week 9: 10 min;% Change from Baseline (n=105, 106) -1.864  (9.684) -0.456  (8.638)
Week 51: 10 min.;% of Predicted Value (n=96, 113) 91.668  (8.223) 93.717  (9.305)
Week 51:10 min;% Change from Baseline (n=96, 113) -2.760  (8.789) 0.228  (13.653)
Week 51 LOCF:10 min;% Predicted Value (n=124, 131) 91.196  (8.366) 93.882  (9.013)
Week 51 LOCF:10 min;% Change from BL (n=124, 131) -3.176  (8.825) -0.029  (12.946)
Baseline: 60 minutes (n=125, 131) 94.284  (6.548) 94.688  (5.260)
Week 9: 60 min.; % of Predicted Value (n=105, 105) 93.586  (8.219) 94.950  (7.526)
Week 9: 60 min;% Change from Baseline (n=105, 105) -0.450  (9.464) -0.031  (7.497)
Week 51: 60 min.; % of Predicted Value (n=99, 112) 92.302  (7.949) 94.084  (9.069)
Week 51:60 min.;% Change from Baseline (n=99, 112) -1.699  (9.015) -0.247  (10.349)
Week 51 LOCF:60 min;% Predicted Value (n=125, 131) 92.418  (8.544) 94.300  (8.823)
Week 51 LOCF:60 min;% Change from BL (n=125, 131) -1.714  (9.512) -0.222  (9.816)
14.Secondary Outcome
Title Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin
Hide Description Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.
Time Frame Baseline, Week 9, Week 51
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 122 129
Mean (Standard Deviation)
Unit of Measure: ml/min/mmHg
Baseline: 10 minutes (n=122, 129) -0.163  (0.992) -0.184  (0.985)
Week 9: 10 minutes (n=102, 104) -0.241  (1.390) -0.131  (1.006)
Week 51: 10 minutes (n=95, 109) -0.139  (0.893) -0.171  (0.820)
Baseline: 60 minutes (n=135, 133) -0.446  (1.115) -0.451  (1.258)
Week 9: 60 minutes (n=104, 108) -0.338  (1.416) -0.159  (1.126)
Week 51: 60 minutes (n=101, 110) -0.216  (1.458) -0.383  (1.030)
15.Secondary Outcome
Title Methacholine Challenge
Hide Description Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.
Time Frame 1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)
Hide Outcome Measure Data
Hide Analysis Population Description
There were no methacholine challenges performed in subjects using inhaled insulin due to protocol-defined exclusion criteria for methacholine challenge testing, and methacholine provocative concentration [of methacholine] causing a 20% fall in FEV1 (PC20) data were not analyzed.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.
Time Frame Week -3 through Week 52
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Hide Analysis Population Description
Mean weekly morning and evening peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)
Hide Description All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.
Time Frame Daily: Baseline to end of study
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Hide Analysis Population Description
Mean weekly number of puffs of albuterol was not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage
Hide Description All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.
Time Frame Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58
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Hide Analysis Population Description
Data for the number of step-up and step-down changes in classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Step Classification of Asthma Severity by Medication Usage
Hide Description Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.
Time Frame Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Data for step classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Mean Weekly Asthma Symptom Scores
Hide Description Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).
Time Frame Baseline through end of study
Hide Outcome Measure Data
Hide Analysis Population Description
Data for mean weekly asthma symptom scores were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Incidence of Non-severe Asthma Exacerbations
Hide Description Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) <80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 <60% of Baseline at any time. Percent of Baseline = 100*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.
Time Frame 0 to 1 week to > 12 months
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Hide Analysis Population Description
FAS; review of source data for this endpoint showed excessive data variability for home-monitored FEV1 with outliers ranging from 0.01 to >100, and many subjects with random peaks and dips of 100% or more of their baseline. It is unlikely that the protocol definition is robust enough to provide real information about exacerbation frequencies.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: events/subject-months
0 to 1 Week (n=141, 139) 0.43 0.41
>1 to 2 Weeks (n=141, 139) 0.28 0.38
>2 to 3 Weeks (n=141, 139) 0.22 0.31
>3 to 4 Weeks (n=141, 139) 0.37 0.41
>4 to 6 Weeks (n=141, 139) 0.52 0.36
>6 to 9 Weeks (n=138, 139) 0.53 0.51
>9 to 12 Weeks (n=134, 138) 0.35 0.46
>3 Months (n=133, 137) 0.40 0.40
>6 to 9 Months (n=121, 133) 0.30 0.49
>9 to 12 Months (n=114, 131) 0.27 0.43
>12 Months (n=67, 81) 0.34 0.21
Overall (n=141, 139) 0.35 0.43
22.Secondary Outcome
Title Incidence of Severe Asthma Exacerbations
Hide Description Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months * 100.
Time Frame 0 to 1 Week to > 12 Months
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Hide Analysis Population Description
Full analysis set (FAS); due to inconsistencies in data entry for systemic steroids, the protocol definition for severe asthma exacerbations, which was based on systemic corticosteroid use for asthma, could not be accurately assessed. Due the small number of events the incidence of severe asthma exacerbations was assessed per 100 months.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: events/subject months*100
0 to 1 Week (n=141, 139) 0.00 0.00
>1 to 2 Weeks (n=141, 139) 0.00 3.13
>2 to 3 Weeks (n=141, 139) 0.00 9.39
>3 to 4 Weeks (n=141, 139) 3.08 0.00
>4 to 6 Weeks (n=141, 139) 4.63 1.56
>6 to 9 Weeks (n=138, 139) 1.06 0.00
>9 to 12 Weeks (n=134, 138) 1.09 0.00
>3 Months (n=133, 137) 1.20 2.27
>6 to 9 Months (n=121, 133) 1.43 1.01
>9 to 12 Months (n=114, 131) 1.53 1.33
>12 Months (n=67, 81) 3.39 0.00
Overall (n=141, 139) 1.46 1.47
23.Secondary Outcome
Title Number of Systemic Corticosteroid Rescues
Hide Description Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = >=2 consecutive days between the end of one event and the start of another event.
Time Frame Baseline through Week 52
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Full analysis set (FAS); number of subjects with systemic corticosteroid rescues = inhaled insulin: 12, and subcutaneous insulin: 14. Due to inconsistencies in data entry, the numbers of systemic corticosteroid rescues were not considered entirely accurate.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 141 139
Measure Type: Number
Unit of Measure: systemic corticosteriod rescues
14 16
24.Secondary Outcome
Title Asthma Control as Measured by the Asthma Control Questionnaire©
Hide Description Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (>95% predicted) to 6 (<50% predicted). Overall score = mean of questions 1 - 7.
Time Frame Baseline, Weeks 4, 12, 26, 39, 52
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FAS; abbreviations: Eval = evaluations, BL = Baseline.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 138 138
Mean (Standard Deviation)
Unit of Measure: scores on scale
Baseline: Subject Evaluation (n=138, 138) 1.04  (0.78) 1.21  (0.91)
Baseline: Clinical Evaluation (n=138, 138) 2.50  (1.50) 2.54  (1.70)
Baseline: Overall Evaluation (n=138, 138) 1.25  (0.74) 1.40  (0.86)
Week 4: Subject Evaluation (n=123, 121) 1.08  (0.81) 1.15  (0.89)
Week 4: Clinical Evaluation (n=123, 121) 2.68  (1.52) 2.65  (1.61)
Week 4: Overall Evaluation (n=123, 121) 1.31  (0.78) 1.36  (0.81)
Week 12: Subject Evaluation (n=129, 134) 1.04  (0.83) 1.17  (0.91)
Week 12: Clinical Evaluation (n=129, 134) 2.55  (1.50) 2.61  (1.48)
Week 12: Overall Evaluation (n=129, 134) 1.25  (0.77) 1.37  (0.83)
Week 26: Subject Evaluation (n=121, 131) 1.06  (0.80) 1.07  (0.91)
Week 26: Clinical Evaluation (n=121, 131) 2.48  (1.43) 2.61  (1.57)
Week 26: Overall Evaluation (n=121, 131) 1.27  (0.74) 1.29  (0.85)
Week 39: Subject Evaluation (n=110, 125) 0.94  (0.76) 1.00  (0.85)
Week 39: Clinical Evaluation (n=110, 125) 2.54  (1.43) 2.63  (1.52)
Week 39: Overall Evaluation (n=110, 125) 1.17  (0.71) 1.23  (0.81)
Week 52: Subject Evaluation (n=107, 120) 1.08  (1.07) 0.98  (0.84)
Week 52: Clinical Evaluation (n=107, 120) 2.77  (1.54) 2.64  (1.56)
Week 52: Overall Evaluation (n=107, 120) 1.32  (0.99) 1.21  (0.80)
Week 4: Subject Eval: Change from BL (n=122, 120) 0.02  (0.59) -0.07  (0.59)
Week 4: Clinical Eval: Change from BL (n=122, 120) 0.17  (0.85) 0.14  (0.85)
Week 4: Overall Eval: Change from BL (n=122, 120) 0.04  (0.55) -0.04  (0.53)
Week 12: Subject Eval: Change from BL (n=129, 134) -0.02  (0.66) -0.04  (0.72)
Week 12 Clinical Eval: Change from BL (n=129, 134) 0.12  (0.94) 0.09  (0.91)
Week 12: Overall Eval: Change from BL (n=129, 134) 0.00  (0.59) -0.02  (0.62)
Week 26: Subject Eval: Change from BL (n=121, 130) 0.05  (0.77) -0.12  (0.82)
Week 26 Clinical Eval: Change from BL (n=121, 130) 0.09  (0.78) 0.09  (1.00)
Week 26: Overall Eval: Change from BL (n=121, 130) 0.05  (0.68) -0.09  (0.73)
Week 39: Subject Eval: Change from BL (n=110, 124) -0.09  (0.65) -0.19  (0.77)
Week 39 Clinical Eval: Change from BL (n=110, 124) 0.14  (1.05) 0.11  (0.94)
Week 39: Overall Eval: Change from BL (n=110, 124) -0.06  (0.58) -0.15  (0.68)
Week 52: Subject Eval: Change from BL (n=106, 119) 0.06  (0.88) -0.19  (0.86)
Week 52 Clinical Eval: Change from BL (n=106, 119) 0.38  (0.87) 0.10  (1.20)
Week 52: Overall Eval: Change from BL (n=106, 119) 0.11  (0.77) -0.15  (0.77)
25.Secondary Outcome
Title Baseline Dyspnea Index (BDI)
Hide Description Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).
Time Frame run-in period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 139 138
Mean (Standard Deviation)
Unit of Measure: scores on scale
Functional Impairment 3.37  (0.80) 3.36  (0.87)
Magnitude of Task 2.29  (1.19) 2.29  (1.25)
Magnitude of Effort 2.49  (1.39) 2.34  (1.49)
Total Score 8.15  (2.98) 7.97  (2.99)
26.Secondary Outcome
Title Transition Dyspnea Index (TDI): Change in Total Score
Hide Description Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).
Time Frame Week 4, Week 12, Week 26, Week 39, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 131 135
Mean (Standard Deviation)
Unit of Measure: scores on scale
Week 4 (n=121, 122) 0.36  (1.93) 0.50  (1.92)
Week 12 (n=131, 135) 0.51  (1.76) 0.47  (1.68)
Week 26 (n=124, 131) 0.14  (1.75) 0.13  (1.55)
Week 39 (n=112, 127) 0.26  (1.56) 0.29  (1.61)
Week 52 (n=105, 121) 0.13  (1.65) 0.67  (2.01)
27.Secondary Outcome
Title Glycosylated Hemoglobin (HbA1c)
Hide Description Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.
Time Frame Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 135 135
Mean (Standard Deviation)
Unit of Measure: percent
Baseline (n=135, 135) 7.62  (1.12) 7.43  (1.08)
Week 6: Observed Value (n=127, 126) 7.22  (1.00) 6.97  (0.90)
Week 6: Change from Baseline (n=127, 126) -0.38  (0.65) -0.43  (0.49)
Week 12: Observed Value (n=122, 127) 7.28  (1.12) 6.98  (0.97)
Week 12: Change from Baseline (n=122, 127) -0.32  (0.98) -0.48  (0.69)
Week 26: Observed Value (n=118, 120) 7.38  (1.24) 7.19  (1.18)
Week 26: Change from Baseline (n=118, 120) -0.12  (1.07) -0.25  (0.93)
Week 39: Observed Value (n=108, 123) 7.44  (1.31) 7.20  (1.16)
Week 39: Change from Baseline (n=108, 123) -0.08  (1.10) -0.21  (0.91)
Week 52: Observed Value (n=101, 118) 7.51  (1.35) 7.35  (1.28)
Week 52: Change from Baseline (n=101, 118) 0.00  (1.05) -0.05  (1.01)
Week 52 (LOCF): Observed Value (n=135, 135) 7.58  (1.35) 7.40  (1.36)
Week 52 (LOCF): Change from Baseline (n=135, 135) -0.04  (1.07) -0.03  (1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval 90%
-0.06 to 0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval 90%
0.04 to 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval 90%
-0.01 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval 90%
-0.03 to 0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval 90%
-0.12 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 90%
-0.19 to 0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Fasting Plasma Glucose
Hide Description Fasting plasma glucose (milligrams per deciliter [mg/dL]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.
Time Frame Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set (PAS); Last Observation Carried Forward: if the end of study value was missing the last available observation for that subject was used..
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 112 123
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=112, 123) 149.22  (49.92) 149.03  (58.33)
Week 6: Observed Value (n=103, 112) 143.02  (68.92) 136.54  (57.98)
Week 6: Change from Baseline (n=103, 112) -3.34  (68.47) -15.19  (67.16)
Week 12: Observed Value (n=106, 113) 136.32  (63.00) 144.47  (61.22)
Week 12: Change from Baseline (n=106, 113) -12.16  (65.62) -5.40  (67.71)
Week 26: Observed Value (n=102, 114) 139.05  (64.63) 143.54  (52.09)
Week 26: Change from Baseline (n=102, 114) -11.86  (76.07) -4.63  (65.10)
Week 39: Observed Value (n=102, 115) 143.64  (63.89) 142.91  (66.26)
Week 39: Change from Baseline (n=102, 115) -5.67  (67.65) -7.47  (65.55)
Week 52: Observed Value (n=98, 115) 146.32  (66.04) 145.43  (59.35)
Week 52: Change from Baseline (n=98, 115) -3.86  (60.61) -2.53  (63.23)
Week 52 LOCF: Observed Value (n=112, 123) 148.28  (71.07) 144.96  (58.80)
Week 52 LOCF: Change from Baseline (n=112, 123) -0.95  (72.53) -4.07  (62.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Confidence interval for the LS mean of that particular treatment.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.615
Confidence Interval 90%
-2.351 to 23.581
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.874
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.942
Confidence Interval 90%
-19.79 to 5.909
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.804
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.622
Confidence Interval 90%
-17.63 to 8.382
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.897
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.828
Confidence Interval 90%
-11.16 to 14.817
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.888
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.149
Confidence Interval 90%
-12.01 to 14.307
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.991
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.247
Confidence Interval 90%
-8.664 to 17.157
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.816
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Body Weight: Mean Baseline and Change From Baseline
Hide Description Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.
Time Frame Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set (PAS)
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 113 124
Mean (Standard Deviation)
Unit of Measure: kilograms
Baseline (n=113, 124) 87.41  (21.04) 87.13  (17.58)
Week 1: Change from Baseline (n=102, 113) -0.02  (1.45) 1.00  (7.63)
Week 2: Change from Baseline (n=104, 105) 0.12  (1.31) 0.57  (1.50)
Week 3: Change from Baseline (n=103, 113) 0.18  (1.64) 0.34  (1.55)
Week 4: Change from Baseline (n=101, 119) 0.31  (1.74) 0.44  (1.70)
Week 6: Change from Baseline (n=106, 122) 0.13  (1.93) 0.68  (1.88)
Week 9: Change from Baseline (n=101, 104) 0.14  (2.31)