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Trial record 20 of 50 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

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: NCT00137046
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 29, 2005
Results First Posted : January 26, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Subcutaneous Insulin
Drug: Inhaled Insulin
Enrollment 582

Recruitment Details A total of 64 centers took part in the study between 09 May 2002 and 08 December 2008.
Pre-assignment Details At the screening visit and during the 4-week run-in phase all subjects received a subcutaneous insulin regimen consisting of 2 to 3 doses per day of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 doses daily of intermediate-/long-acting insulin (NPH insulin or Ultralente), or insulin glargine once daily at bedtime.
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 291 [1] 291 [2]
Received Study Treatment 290 290
Completed 192 [3] 198
Not Completed 99 93
Reason Not Completed
Death             2             1
Adverse Event             16             5
Laboratory Abnormality             2             0
Lack of Efficacy             13             1
Lost to Follow-up             8             24
Other             23             19
Withdrawal by Subject             33             42
Adverse Event 4 Days after Last Dose             1             0
Withdrew prior to study treatment             1             1
[1]
One subject was randomized to inhaled insulin but never received treatment.
[2]
One subject was randomized to subcutaneous insulin but never received treatment.
[3]
Completed subjects were those subjects who did not discontinue while on active drug.
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 290 290 580
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 290 participants 290 participants 580 participants
18 to 25 48 53 101
26 to 35 81 96 177
36 to 45 94 71 165
46 to 55 52 48 100
56 to 65 15 22 37
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 290 participants 580 participants
Female
121
  41.7%
129
  44.5%
250
  43.1%
Male
169
  58.3%
161
  55.5%
330
  56.9%
1.Primary Outcome
Title Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Hide Description Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value).
Time Frame Baseline through Extension Follow-up Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.
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 283 281
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=283, 281) 3.51  (0.76) 3.47  (0.78)
Month 3 (n=277, 263) -0.04  (0.12) -0.01  (0.12)
Month 6 (n=262, 273) -0.05  (0.14) -0.03  (0.13)
Month 9 (n=251, 264) -0.06  (0.14) -0.04  (0.13)
Month 12 (n=242, 259) -0.08  (0.14) -004  (0.13)
Month 15 (n=236, 250) -0.09  (0.16) -0.05  (0.15)
Month 18 (n=227, 232) -0.09  (0.15) -0.06  (0.15)
Month 21 (n=218, 224) -0.11  (0.16) -0.06  (0.15)
Month 24 (n=211, 219) -0.12  (0.17) -0.08  (0.16)
Follow-up Month 1 (n=242, 209) -0.11  (0.17) -0.09  (0.16)
Follow-up Month 3 (n=249, 225) -0.10  (0.16) -0.09  (0.15)
Follow-up Month 6 (n=240, 218) -0.10  (0.17) -0.09  (0.16)
Extension Month 1 (n=166, 175) -0.14  (0.20) -0.10  (0.17)
Extension Month 3 (n=161, 175) -0.14  (0.18) -0.10  (0.18)
Extension Month 6 (n=158, 170) -0.15  (0.19) -0.11  (0.17)
Extension Month 9 (n=151, 164) -0.16  (0.18) -0.12  (0.19)
Extension Month 12 (n=152,161) -0.17  (0.19) -0.11  (0.16)
Extension Month 15 (n=153,162) -0.16  (0.19) -0.12  (0.17)
Extension Month 18 (n=148,160) -0.18  (0.20) -0.14  (0.19)
Extension Month 21 (n=144,158) -0.17  (0.19) -0.15  (0.20)
Extension Month 24 (n=141,153) -0.18  (0.20) -0.14  (0.20)
Extension Month 27 (n=136,146) -0.19  (0.20) -0.13  (0.19)
Extension Month 30 (n=136,147) -0.20  (0.20) -0.16  (0.19)
Extension Month 33 (n=127,139) -0.20  (0.21) -0.17  (0.19)
Extension Month 36 (n=105,126) -0.23  (0.22) -0.16  (0.18)
Extension Month 39 (n=52, 64) -0.21  (0.23) -0.17  (0.21)
Extension Month 39 (LOCF) (n=177, 187) -0.22  (0.21) -0.15  (0.19)
Extension Follow Up Month 3 (n=115,102) -0.20  (0.20) -0.17  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.024
Confidence Interval 90%
-0.041 to -0.007
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.010
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.022
Confidence Interval 90%
-0.040 to -0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.011
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.019
Confidence Interval 90%
-0.038 to 0.001
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.012
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.038
Confidence Interval 90%
-0.058 to -0.019
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.012
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.042
Confidence Interval 90%
-0.065 to -0.020
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.020
Confidence Interval 90%
-0.043 to 0.002
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.043
Confidence Interval 90%
-0.066 to -0.020
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.033
Confidence Interval 90%
-0.058 to -0.009
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.015
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.015
Confidence Interval 90%
-0.039 to 0.009
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.015
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.005
Confidence Interval 90%
-0.027 to 0.017
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.013
Confidence Interval 90%
-0.037 to 0.012
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.015
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 90%
-0.076 to -0.014
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.019
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 90%
-0.076 to -0.013
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.019
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.040
Confidence Interval 90%
-0.071 to -0.008
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.019
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.041
Confidence Interval 90%
-0.074 to -0.008
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.020
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.056
Confidence Interval 90%
-0.088 to -0.025
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.019
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.039
Confidence Interval 90%
-0.071 to -0.007
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.019
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.044
Confidence Interval 90%
-0.079 to -0.010
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.021
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.020
Confidence Interval 90%
-0.055 to 0.016
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.042
Confidence Interval 90%
-0.079 to -0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.055
Confidence Interval 90%
-0.091 to -0.019
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 90%
-0.081 to -0.010
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.036
Confidence Interval 90%
-0.073 to 0.002
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.023
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.079
Confidence Interval 90%
-0.121 to -0.038
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.061
Confidence Interval 90%
-0.124 to 0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.038
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.066
Confidence Interval 90%
-0.098 to -0.033
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.020
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.044
Confidence Interval 90%
-0.085 to -0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments [Not Specified]
2.Primary Outcome
Title Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Hide Description Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.
Time Frame Month 3 through Extension Follow-up 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
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 283 281
Measure Type: Number
Unit of Measure: participants
Month 3 (n=277, 263) 0 0
Month 6 (n=262, 273) 0 0
Month 9 (n=251, 264) 0 1
Month 12 (n=242, 259) 1 0
Month 15 (n=236, 250) 3 1
Month 18 (n=227, 232) 0 3
Month 21 (n=218, 224) 2 3
Month 24 (n=211, 219) 3 2
Follow-up Month 1 (n=242, 209) 2 2
Follow-up Month 3 (n=249, 225) 3 3
Follow-up Month 6 (n=240, 218) 5 1
Extension Month 1 (n=166, 175) 2 2
Extension Month 3 (n=161, 175) 4 2
Extension Month 6 (n=158, 170) 2 2
Extension Month 9 (n=151, 164) 3 2
Extension Month 12 (n=152, 161) 2 0
Extension Month 15 (n=153, 162) 1 0
Extension Month 18 (n=148, 160) 4 3
Extension Month 21 (n=144, 158) 4 5
Extension Month 24 (n=141, 153) 3 5
Extension Month 27 (n=136, 146) 6 4
Extension Month 30 (n=136, 147) 6 2
Extension Month 33 (n=127, 139) 4 3
Extension Month 36 (n=105, 126) 7 3
Extension Month 39 (n=52, 64) 2 1
Extension Follow Up Month 3 (n=115, 102) 5 1
3.Primary Outcome
Title Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Hide Description Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value).
Time Frame Baseline through Extension Follow-up Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Due to study termination, originally planned inferential analysis change from Month 3 to extension Month 60 was not done.
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 283 281
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
Baseline (n=283, 281) 28.09  (6.20) 27.18  (6.40)
Month 3 (n=277, 264) -1.09  (1.73) -0.29  (1.71)
Month 6 (n=262, 273) -1.17  (2.16) -0.26  (1.85)
Month 9 (n=250, 266) -1.16  (2.09) -0.41  (1.91)
Month 12 (n=241, 258) -1.40  (2.15) -0.41  (2.15)
Month 15 (n=235, 249) -1.16  (2.17) -0.42  (2.17)
Month 18 (n=227, 232) -1.21  (2.28) -0.45  (2.22)
Month 21 (n=218, 224) -1.29  (2.49) -0.56  (2.07)
Month 24 (n=208, 219) -1.28  (2.29) -0.71  (2.40)
Follow-up Month 1 (n=242,208) -0.81  (2.20) -0.81  (2.42)
Follow-up Month 3 (n=247,225) -0.77  (2.46) -0.80  (2.10)
Follow-up Month 6 (n=240,218) -0.77  (2.36) -0.67  (2.28)
Extension Month 1 (n=166,175) -1.15  (2.54) -0.55  (2.35)
Extension Month 3 (n=161,173) -1.43  (2.37) -0.73  (2.45)
Extension Month 6 (n=158,169) -1.38  (2.37) -0.78  (2.54)
Extension Month 9 (n=151,163) -1.17  (2.52) -0.74  (2.57)
Extension Month 12 (n=152,161) -1.70  (2.46) -0.70  (2.60)
Extension Month 15 (n=143,160) -1.70  (2.27) -0.72  (2.94)
Extension Month 18 (n=148,159) -1.67  (2.36) -1.02  (2.72)
Extension Month 21 (n=144,156) -1.51  (2.59) -0.88  (2.64)
Extension Month 24 (n=140,152) -1.63  (2.46) -0.70  (2.72)
Extension Month 27 (n=136,144) -1.25  (2.65) -0.76  (2.75)
Extension Month 30 (n=135,146) -1.36  (2.54) -0.75  (2.59)
Extension Month 33 (n=127,139) -1.31  (2.54) -0.81  (2.55)
Extension Month 36 (n=105,122) -1.53  (2.53) -0.96  (2.82)
Extension Month 39 (n=52, 64) -2.02  (3.72) -0.93  (2.59)
Extension Month 39 (LOCF) (n=177, 187) -1.66  (2.90) -0.90  (2.55)
Extension Follow Up Month 3 (n=115, 101) -0.89  (2.35) -1.11  (2.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.744
Confidence Interval 90%
-0.981 to -0.506
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.144
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.797
Confidence Interval 90%
-1.073 to -0.522
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.167
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.667
Confidence Interval 90%
-0.949 to -0.384
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.171
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.826
Confidence Interval 90%
-1.123 to -0.528
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.181
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.610
Confidence Interval 90%
-0.923 to -0.296
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.190
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.577
Confidence Interval 90%
-0.910 to -0.245
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 Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.613
Confidence Interval 90%
-0.962 to -0.263
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.212
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.385
Confidence Interval 90%
-0.736 to -0.034
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.150
Confidence Interval 90%
-0.197 to 0.497
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.211
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.166
Confidence Interval 90%
-0.160 to 0.492
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.198
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.069
Confidence Interval 90%
-0.274 to 0.411
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.208
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.460
Confidence Interval 90%
-0.876 to -0.043
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.252
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.579
Confidence Interval 90%
-0.986 to -0.172
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.247
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.460
Confidence Interval 90%
-0.880 to -0.040
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.255
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.385
Confidence Interval 90%
-0.822 to 0.053
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.265
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.930
Confidence Interval 90%
-1.372 to -0.487
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.268
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.823
Confidence Interval 90%
-1.296 to -0.351
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.286
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.525
Confidence Interval 90%
-0.965 to -0.084
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.267
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.647
Confidence Interval 90%
-1.104 to -0.191
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.276
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.853
Confidence Interval 90%
-1.340 to -0.367
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.295
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.390
Confidence Interval 90%
-0.890 to 0.111
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.303
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.636
Confidence Interval 90%
-1.119 to -0.153
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.293
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.522
Confidence Interval 90%
-1.000 to -0.043
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.290
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.744
Confidence Interval 90%
-1.315 to -0.173
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.346
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.378
Confidence Interval 90%
-2.420 to -0.335
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.628
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.720
Confidence Interval 90%
-1.183 to -0.258
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.280
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.061
Confidence Interval 90%
-0.594 to 0.472
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.323
Estimation Comments [Not Specified]
4.Primary Outcome
Title Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Hide Description Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.
Time Frame Month 3 through Extension Follow-up Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
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 283 281
Measure Type: Number
Unit of Measure: participants
Month 3 (n=277, 264) 0 1
Month 6 (n=262, 273) 1 0
Month 9 (n=250, 266) 2 1
Month 12 (n=241, 258) 2 1
Month 15 (n=235, 249) 1 2
Month 18 (n=227, 232) 5 4
Month 21 (n=218, 224) 4 2
Month 24 (n=208, 219) 2 2
Follow-up Month 1 (n=242, 208) 3 3
Follow-up Month 3 (n=247, 225) 1 1
Follow-up Month 6 (n=240, 218) 1 2
Extension Month 1 (n=166, 175) 5 0
Extension Month 3 (n=161, 173) 4 1
Extension Month 6 (n=158, 169) 4 2
Extension Month 9 (n=151, 163) 2 2
Extension Month 12 (n=152, 161) 5 2
Extension Month 15 (n=143, 160) 3 2
Extension Month 18 (n=148, 159) 1 4
Extension Month 21 (n=144, 156) 5 3
Extension Month 24 (n=140, 152) 5 1
Extension Month 27 (n=136, 144) 4 2
Extension Month 30 (n=135, 146) 4 4
Extension Month 33 (n=127, 139) 3 2
Extension Month 36 (n=105, 122) 4 7
Extension Month 39 (n=52, 64) 3 1
Extension Follow Up Month 3 (n=115, 101) 3 2
5.Primary Outcome
Title Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).
Time Frame Week -2 through Extension Follow-up Month 6 or end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Annual Rate of Change in FEV1 were not summarized as planned.
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.
6.Primary Outcome
Title Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
Hide Description Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).
Time Frame Week -2 through Extension Follow-up Month 6 or end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the annual rate of change in DLco were not summarized as planned.
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.
7.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Hide Description Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).
Time Frame Baseline through Extension Follow-up Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
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 288 286
Mean (Standard Deviation)
Unit of Measure: percent
Baseline (n=288, 286) 7.41  (1.06) 7.46  (1.06)
Week 6 (n=269, 256) -0.40  (0.61) -0.43  (0.61)
Month 3 (n=276, 280) -0.36  (0.78) -0.41  (0.73)
Month 6 (n=263, 274) -0.21  (0.80) -0.36  (0.81)
Month 9 (n=253, 266) -0.10  (0.84) -0.23  (0.81)
Month 12 (n=240, 262) -0.04  (0.87) -0.32  (0.82)
Month 15 (n=236, 253) -0.12  (0.85) -0.29  (0.90)
Month 18 (n=231, 237) -0.11  (0.88) -0.30  (0.89)
Month 21 (n=223, 231) -0.05  (0.92) -0.25  (0.92)
Month 24 (n=214, 225) 0.05  (0.91) -0.27  (0.83)
Follow-up Month 3 (n=205, 195) -0.13  (0.87) -0.22  (0.83)
Follow-up Month 6 (n=219, 221) -0.10  (0.87) -0.14  (0.87)
Extension Month 1 (n=171, 177) -0.09  (0.90) -0.23  (0.85)
Extension Month 3 (n=170, 177) 0.12  (0.95) -0.17  (0.91)
Extension Month 6 (n=166, 178) 0.21  (0.99) -0.19  (0.86)
Extension Month 9 (n=159, 171) 0.26  (1.00) -0.06  (0.94)
Extension Month 12 (n=158, 169) 0.39  (0.98) 0.08  (0.87)
Extension Month 15 (n=156, 167) 0.40  (1.05) 0.17  (0.85)
Extension Month 18 (n=153, 166) 0.32  (0.94) 0.05  (0.86)
Extension Month 21 (n=154, 161) 0.27  (0.99) 0.00  (0.88)
Extension Month 24 (n=149, 154) 0.29  (0.89) 0.06  (0.91)
Extension Month 27 (n=141, 151) 0.33  (0.97) 0.10  (0.92)
Extension Month 30 (n=140, 150) 0.33  (0.91) -0.01  (0.89)
Extension Month 33 (n=131, 143) 0.40  (0.94) -0.08  (0.92)
Extension Month 36 (n=108, 132) 0.30  (0.99) -0.03  (0.99)
Extension Month 39 (n=55, 66) 0.30  (0.94) -0.09  (1.00)
Extension Follow-Up Month 3 (n=120, 107) 0.14  (1.00) 0.12  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.031
Confidence Interval 90%
-0.060 to 0.122
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.055
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.136
Confidence Interval 90%
0.033 to 0.239
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.062
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.112
Confidence Interval 90%
-0.000 to 0.224
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.068
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.257
Confidence Interval 90%
0.141 to 0.374
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.156
Confidence Interval 90%
0.040 to 0.273
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.182
Confidence Interval 90%
0.065 to 0.300
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.072
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.190
Confidence Interval 90%
0.060 to 0.319
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.078
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.316
Confidence Interval 90%
0.190 to 0.443
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.077
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.093
Confidence Interval 90%
-0.037 to 0.224
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.079
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.021
Confidence Interval 90%
-0.103 to 0.145
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.112
Confidence Interval 90%
-0.023 to 0.248
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.273
Confidence Interval 90%
0.126 to 0.419
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.089
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.363
Confidence Interval 90%
0.219 to 0.507
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.087
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.278
Confidence Interval 90%
0.128 to 0.428
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.091
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.293
Confidence Interval 90%
0.144 to 0.442
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.091
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.213
Confidence Interval 90%
0.058 to 0.369
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.094
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.243
Confidence Interval 90%
0.101 to 0.386
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.086
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.227
Confidence Interval 90%
0.079 to 0.376
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.090
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.225
Confidence Interval 90%
0.079 to 0.372
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.089
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.211
Confidence Interval 90%
0.055 to 0.368
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.095
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.331
Confidence Interval 90%
0.180 to 0.483
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.092
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.462
Confidence Interval 90%
0.302 to 0.622
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.097
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.410
Confidence Interval 90%
0.221 to 0.600
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.115
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.451
Confidence Interval 90%
0.183 to 0.718
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.161
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.032
Confidence Interval 90%
-0.174 to 0.237
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.124
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Hypoglycemic Event Rates
Hide Description A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.
Time Frame Month 1 through Extension Month 39
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
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 288 286
Measure Type: Number
Unit of Measure: total events/subject months
Month 1 (n=288, 286) 7.6 6.3
Month 2 (n=282, 286) 5.9 5.5
Month 3 (n=279, 285) 5.8 5.3
Month 4 (n=273, 282) 4.8 4.6
Month 5 (n=266, 280) 4.7 4.4
Month 6 (n=263, 277) 4.5 4.2
Month 7 (n=259, 275) 4.5 4.3
Month 8 (n=257, 273) 4.2 3.8
Month 9 (n=254, 272) 3.8 3.7
Month 10 (n=249, 270) 4.2 3.9
Month 11 (n=245, 269) 3.9 3.4
Month 12 (n=243, 267) 3.8 3.8
Month 13 (n=239, 265) 3.6 3.5
Month 14 (n=237, 260) 3.6 3.6
Month 15 (n=236, 258) 3.2 3.3
Month 16 (n=236, 256) 3.4 3.5
Month 17 (n=235, 252) 3.0 3.1
Month 18 (n=233, 250) 3.0 3.1
Month 19 (n=232, 250) 3.2 3.0
Month 20 (n=227, 245) 3.0 3.2
Month 21 (n=226, 244) 3.0 3.0
Month 22 (n=226, 243) 2.8 3.1
Month 23 (n=224, 238) 2.5 2.9
Month 24 (n=222, 229) 2.6 2.5
Extension Month 1 (n=177, 187) 3.5 2.9
Extension Month 2 (n=177, 187) 3.6 2.7
Extension Month 3 (n=172, 185) 4.1 2.9
Extension Month 4 (n=169, 182) 3.2 2.6
Extension Month 5 (n=169, 182) 3.2 2.8
Extension Month 6 (n=168, 182) 2.8 2.5
Extension Month 7 (n=167, 181) 3.1 2.5
Extension Month 8 (n=167, 178) 2.6 2.8
Extension Month 9 (n=165, 177) 2.1 2.6
Extension Month 10 (n=165, 176) 3.1 2.6
Extension Month 11 (n=162, 175) 3.2 2.2
Extension Month 12 (n=160, 175) 3.3 2.5
Extension Month 13 (n=158, 174) 2.8 2.6
Extension Month 14 (n=156, 173) 2.9 2.7
Extension Month 15 (n=156, 173) 3.0 2.3
Extension Month 16 (n=156, 172) 3.4 2.4
Extension Month 17 (n=156, 172) 3.0 2.3
Extension Month 18 (n=156, 172) 3.0 2.2
Extension Month 19 (n=155, 172) 3.2 2.6
Extension Month 20 (n=155, 170) 2.9 2.1
Extension Month 21 (n=155, 169) 2.8 2.3
Extension Month 22 (n=155, 165) 2.8 2.2
Extension Month 23 (n=152, 164) 3.3 2.3
Extension Month 24 (n=152, 163) 2.9 2.1
Extension Month 25 (n=150, 162) 3.2 2.1
Extension Month 26 (n=149, 160) 2.7 2.1
Extension Month 27 (n=147, 159) 2.7 1.9
Extension Month 28 (n=146, 158) 2.7 2.3
Extension Month 29 (n=145, 155) 2.7 2.0
Extension Month 30 (n=143, 153) 2.5 1.9
Extension Month 31 (n=141, 153) 2.6 2.2
Extension Month 32 (n=138, 152) 2.8 2.1
Extension Month 33 (n=136, 150) 2.3 2.1
Extension Month 34 (n=131, 148) 2.0 2.1
Extension Month 35 (n=122, 147) 1.8 2.1
Extension Month 36 (n=113, 138) 1.9 2.4
Extension Month 37 (n=88, 104) 1.5 2.0
Extension Month 38 (n=66, 73) 1.8 1.7
Extension Month 39 (n=53, 64) 1.7 1.4
Overall Comparative (n=288, 286) 4.1 3.9
Overall Extension (n=177, 187) 2.8 2.4
9.Secondary Outcome
Title Severe Hypoglycemic Event Rates
Hide Description Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100.
Time Frame Month 1 through Extension Month 39
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
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 288 286
Measure Type: Number
Unit of Measure: events / subject months * 100
Month 1 (n=288, 286) 10.2 9.1
Month 2 (n=282, 286) 7.9 7.4
Month 3 (n=279, 285) 6.5 6.0
Month 4 (n=273, 282) 3.4 4.3
Month 5 (n=266, 280) 0.0 4.3
Month 6 (n=263, 277) 3.8 6.5
Month 7 (n=259, 275) 2.3 4.0
Month 8 (n=257, 273) 2.0 4.0
Month 9 (n=254, 272) 4.0 5.2
Month 10 (n=249, 270) 0.8 3.3
Month 11 (n=245, 269) 2.1 3.0
Month 12 (n=243, 267) 2.5 3.8
Month 13 (n=239, 265) 1.3 2.7
Month 14 (n=237, 260) 1.3 3.5
Month 15 (n=236, 258) 1.7 3.1
Month 16 (n=236, 256) 2.6 2.0
Month 17 (n=235, 252) 3.9 1.6
Month 18 (n=233, 250) 2.6 5.6
Month 19 (n=232, 250) 0.4 2.4
Month 20 (n=227, 245) 0.4 4.9
Month 21 (n=226, 244) 1.8 2.9
Month 22 (n=226, 243) 0.9 2.1
Month 23 (n=224, 238) 0.9 2.6
Month 24 (n=222, 239) 0.8 2.6
Extension Month 1 (n=177, 187) 3.9 1.2
Extension Month 2 (n=177, 187) 4.0 7.0
Extension Month 3 (n=172, 185) 4.0 2.4
Extension Month 4 (n=169, 182) 1.4 1.2
Extension Month 5 (n=169, 182) 2.7 4.2
Extension Month 6 (n=168, 182) 0.0 3.0
Extension Month 7 (n=167, 181) 0.7 2.4
Extension Month 8 (n=167, 178) 0.0 2.4
Extension Month 9 (n=165, 177) 2.1 4.9
Extension Month 10 (n=165, 176) 0.0 3.0
Extension Month 11 (n=162, 175) 2.8 1.2
Extension Month 12 (n=160, 175) 1.4 4.3
Extension Month 13 (n=158, 174) 0.7 1.8
Extension Month 14 (n=156, 173) 1.4 3.1
Extension Month 15 (n=156, 173) 1.4 11.1
Extension Month 16 (n=156, 172) 0.7 13.7
Extension Month 17 (n=156, 172) 0.7 5.6
Extension Month 18 (n=156, 172) 0.0 7.5
Extension Month 19 (n=155, 172) 1.4 6.9
Extension Month 20 (n=155, 170) 2.1 2.5
Extension Month 21 (n=155, 169) 1.4 3.8
Extension Month 22 (n=155, 165) 2.1 1.3
Extension Month 23 (n=152, 164) 1.4 3.2
Extension Month 24 (n=152, 163) 0.7 3.2
Extension Month 25 (n=150, 162) 1.5 0.0
Extension Month 26 (n=149, 160) 2.2 0.7
Extension Month 27 (n=147, 159) 0.7 0.0
Extension Month 28 (n=146, 158) 0.0 3.4
Extension Month 29 (n=145, 155) 0.0 0.7
Extension Month 30 (n=143, 153) 0.8 0.7
Extension Month 31 (n=141, 153) 3.1 0.0
Extension Month 32 (n=138, 152) 0.0 1.4
Extension Month 33 (n=136, 150) 2.4 1.4
Extension Month 34 (n=131, 148) 0.8 1.4
Extension Month 35 (n=122, 147) 0.0 5.9
Extension Month 36 (n=113, 138) 1.0 0.9
Extension Month 37 (n=88, 104) 0.0 3.8
Extension Month 38 (n=66, 73) 0.0 0.0
Extension Month 39 (n=53, 64) 0.8 1.7
Overall Comparative (n=288, 286) 2.8 4.1
Overall Extension (n=177, 187) 1.4 3.3
10.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose
Time Frame Baseline through Extension Follow-up Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
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 286 286
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=286, 286) 171.24  (63.20) 170.06  (55.20)
Week 6 (n=263, 250) -26.04  (84.79) -14.02  (80.13)
Month 3 (n=267, 276) -21.84  (85.26) -6.15  (79.08)
Month 6 (n=258, 271) -31.48  (81.62) -6.29  (83.81)
Month 9 (n=243, 262) -25.34  (86.24) 1.28  (96.32)
Month 12 (n=232, 256) -24.25  (87.53) -4.95  (85.96)
Month 15 (n=230, 251) -34.75  (83.72) 5.96  (89.39)
Month 18 (n=226, 236) -24.13  (86.44) -8.13  (88.83)
Month 21 (n=216, 230) -26.77  (88.96) -11.62  (82.98)
Month 24 (n=208, 222) -18.36  (92.92) 1.25  (84.87)
Follow-up Month 3 (n=2, 2) -43.50  (85.09) 46.67  (24.04)
Follow-up Month 6 (n=159, 164) 3.45  (80.26) 1.46  (85.49)
Extension Month 1 (n=164, 171) -25.52  (90.15) -2.72  (91.27)
Extension Month 3 (n=167, 172) -25.02  (87.75) 0.43  (84.55)
Extension Month 6 (n=164, 177) -13.47  (80.85) -12.56  (86.93)
Extension Month 9 (n=152, 170) -16.19  (94.12) -4.46  (88.86)
Extension Month 12 (n=155, 167) -22.53  (83.01) -5.15  (81.38)
Extension Month 15 (n=148, 163) -26.11  (85.78) -10.64  (86.00)
Extension Month 18 (n=148, 163) -12.42  (86.69) -2.32  (84.41)
Extension Month 21 (n=152, 157) -24.75  (87.29) 4.86  (89.31)
Extension Month 24 (n=142, 148) -20.46  (86.45) -10.36  (93.08)
Extension Month 27 (n=140, 148) -14.91  (78.42) -2.86  (91.97)
Extension Month 30 (n=138, 147) -17.16  (86.47) -3.77  (86.15)
Extension Month 33 (n=129, 141) -22.77  (94.77) -12.12  (88.26)
Extension Month 36 (n=107, 132) -20.00  (81.03) -2.49  (86.06)
Extension Month 39 (n=55, 64) -38.47  (95.17) -1.57  (78.47)
Extension Follow-Up Month 3 (n=118, 105) 1.97  (95.39) 3.25  (84.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.81
Confidence Interval 90%
-25.24 to -4.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.83
Confidence Interval 90%
-35.16 to -14.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.16
Confidence Interval 90%
-37.56 to -14.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.92
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.46
Confidence Interval 90%
-30.56 to -8.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.74
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -39.97
Confidence Interval 90%
-50.93 to -29.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.65
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.08
Confidence Interval 90%
-27.65 to -4.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.02
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.54
Confidence Interval 90%
-24.69 to -2.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.76
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.86
Confidence Interval 90%
-30.88 to -6.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.29
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.56
Confidence Interval 90%
-9.83 to 16.96
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.12
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.80
Confidence Interval 90%
-31.32 to -4.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.20
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.71
Confidence Interval 90%
-33.44 to -7.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.72
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.80
Confidence Interval 90%
-11.06 to 14.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.80
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.72
Confidence Interval 90%
-23.61 to 6.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.02
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.34
Confidence Interval 90%
-29.28 to -3.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.84
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.99
Confidence Interval 90%
-26.60 to 0.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.25
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.22
Confidence Interval 90%
-24.39 to 3.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.58
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -28.64
Confidence Interval 90%
-43.19 to -14.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.82
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.99
Confidence Interval 90%
-23.69 to 5.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.91
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.52
Confidence Interval 90%
-24.04 to 5.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.80
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.40
Confidence Interval 90%
-24.71 to 3.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.67
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]