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Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00136916
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 29, 2005
Results First Posted : January 18, 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
Interventions Drug: Inhaled Insulin
Drug: Subcutaneous insulin
Enrollment 635

Recruitment Details  
Pre-assignment Details At screening visit and during the 4-week run-in phase subjects received subcutaneous insulin regime of 2 to 3 daily doses (QD) of regular insulin-/short-acting insulin analog (lispro or aspart) and 1 or 2 doses QD of intermediate or long-acting insulin (neutral protamine hagedorn [NPH] insulin or Ultralente®) or insulin glargine QD at bedtime.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime. Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Period Title: Overall Study
Started 319 316
Received Treatment 316 311
Completed 194 [1] 212 [1]
Not Completed 125 104
Reason Not Completed
Never received study treatment             3             5
Death             1             3
Adverse Event             27             8
Laboratory abnormality             0             1
Lack of Efficacy             13             3
Lost to Follow-up             12             14
Withdrawal by Subject             44             46
Other             22             24
Discontinued in follow up period             3             0
[1]
At study termination, active subjects completed end-of-study assessment and 3-month follow-up visit
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin Total
Hide Arm/Group Description Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime. Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime. Total of all reporting groups
Overall Number of Baseline Participants 316 311 627
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 316 participants 311 participants 627 participants
Between 26 and 35 years 2 7 9
Between 36 and 45 years 36 49 85
Between 46 and 55 years 100 93 193
Between 56 and 65 years 117 101 218
Between 66 and 75 years 61 61 122
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 316 participants 311 participants 627 participants
56.7  (9.2) 55.5  (9.9) 56.1  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 311 participants 627 participants
Female
111
  35.1%
118
  37.9%
229
  36.5%
Male
205
  64.9%
193
  62.1%
398
  63.5%
1.Primary Outcome
Title Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).
Time Frame Month 3 through extension Month 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline 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 (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change From Baseline in FEV1
Hide Description Change from baseline: mean of (value of observed FEV1 [L] at treatment 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; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 311 304
Mean (Standard Deviation)
Unit of Measure: L
Baseline (n=311, 304) 2.91  (0.68) 2.93  (0.71)
Month 3 (M3) (n=290, 291) -0.06  (0.13) -0.01  (0.15)
M6 (n=281, 280) -0.05  (0.16) -0.05  (0.17)
M9 (n=266, 276) -0.08  (0.17) -0.07  (0.16)
M12 (n=259, 263) -0.09  (0.17) -0.07  (0.16)
M15 (n=247, 250) -0.12  (0.18) -0.09  (0.17)
M18 (n=237, 236) -0.12  (0.18) -0.10  (0.18)
M21 (n=232, 233) -0.13  (0.18) -0.11  (0.18)
M24 (n=223, 226) -0.15  (0.19) -0.13  (0.18)
Follow-up (FU) M1 (n=249, 221) -0.14  (0.18) -0.14  (0.19)
FU M3 (n=248, 231) -0.13  (0.21) -0.14  (0.20)
FU M6 (n=242, 220) -0.12  (0.20) -0.15  (0.18)
Extension (Ext) M1 (n=161, 163) -0.16  (0.20) -0.16  (0.20)
Ext M3 (n=157, 158) -0.19  (0.21) -0.16  (0.19)
Ext M6 (n=148, 159) -0.20  (0.21) -0.17  (0.20)
Ext M9 (n=144, 157) -0.19  (0.21) -0.16  (0.21)
Ext M12 (n=144, 157) -0.20  (0.21) -0.18  (0.22)
Ext M15 (n=141, 145) -0.22  (0.23) -0.21  (0.20)
Ext M18 (n=135, 139) -0.22  (0.23) -0.21  (0.22)
Ext M21 (n=132, 143) -0.23  (0.24) -0.21  (0.21)
Ext M24 (n=125, 131) -0.24  (0.24) -0.23  (0.22)
Ext M27 (n=124, 125) -0.25  (0.23) -0.24  (0.22)
Ext M30 (n=125, 126) -0.24  (0.22) -0.23  (0.23)
Ext M33 (n=98, 113) -0.24  (0.24) -0.24  (0.22)
Ext M36 (n=54, 60) -0.25  (0.18) -0.28  (0.17)
Ext M36 [LOCF] (n=171, 169) -0.24  (0.24) -0.24  (0.21)
Ext FU M3 (n=119, 115) -0.24  (0.21) -0.25  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.045
Confidence Interval 90%
-0.064 to -0.026
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.011
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.003
Confidence Interval 90%
-0.025 to 0.020
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.010
Confidence Interval 90%
-0.033 to 0.013
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.020
Confidence Interval 90%
-0.044 to 0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.014
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.023
Confidence Interval 90%
-0.048 to 0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.015
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.023
Confidence Interval 90%
-0.050 to 0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.016
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.020
Confidence Interval 90%
-0.047 to 0.007
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.026
Confidence Interval 90%
-0.054 to 0.002
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.007
Confidence Interval 90%
-0.021 to 0.034
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.014
Confidence Interval 90%
-0.016 to 0.044
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.018
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.027
Confidence Interval 90%
-0.002 to 0.055
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.004
Confidence Interval 90%
-0.040 to 0.032
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.022
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.033
Confidence Interval 90%
-0.070 to 0.004
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.023
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.039
Confidence Interval 90%
-0.077 to -0.002
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.023
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.036
Confidence Interval 90%
-0.075 to 0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.018
Confidence Interval 90%
-0.058 to 0.022
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.024
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.007
Confidence Interval 90%
-0.034 to 0.048
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.025
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.011
Confidence Interval 90%
-0.055 to 0.033
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.015
Confidence Interval 90%
-0.058 to 0.029
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.026
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.015
Confidence Interval 90%
-0.061 to 0.030
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.028
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.000
Confidence Interval 90%
-0.044 to 0.043
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.026
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.005
Confidence Interval 90%
-0.051 to 0.040
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.027
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M33
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.008
Confidence Interval 90%
-0.042 to 0.058
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.030
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.024
Confidence Interval 90%
-0.030 to 0.077
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.032
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36 LOCF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.003
Confidence Interval 90%
-0.042 to 0.035
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.023
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.019
Confidence Interval 90%
-0.023 to 0.062
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.026
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
3.Primary Outcome
Title Annual Rate of Change in 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 3 or end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Summary of ≥ 15 % Decliners in FEV1
Hide Description Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 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 (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 311 304
Measure Type: Number
Unit of Measure: participants
M3 (n=290, 291) 2 2
M6 (n=281, 280) 3 4
M9 (n=266, 276) 7 5
M12 (n=259, 263) 7 4
M15 (n=247, 250) 13 6
M18 (n=237, 236) 10 8
M21 (n=232, 233) 12 8
M24 (n=223, 226) 14 13
FU M1 (n=249, 221) 11 7
FU M3 (n=248, 231) 16 15
FU M6 (n=242, 220) 13 11
Ext M1 (n=161, 163) 12 6
Ext M3 (n=157, 158) 12 5
Ext M6 (n=148, 159) 14 8
Ext M9 (n=144, 157) 11 10
Ext M12 (n=144, 157) 19 13
Ext M15 (n=141, 145) 15 11
Ext M18 (n=135, 139) 17 18
Ext M21 (n=132, 143) 22 11
Ext M24 (n=125, 131) 22 16
Ext M27 (n=124, 125) 18 14
Ext M30 (n=125, 126) 20 18
Ext M33 (n=98, 113) 10 12
Ext M36 (n=54, 60) 5 6
Ext FU M3 (n=119, 115) 14 19
5.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 mercury per year (ml/min/mmHg/yr).
Time Frame Week -2 through extension follow up Month 3 or end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco).
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Hide Description Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment 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; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco).
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 308 303
Mean (Standard Deviation)
Unit of Measure: ml/min/mmHg
Baseline (n=308, 303) 24.13  (5.54) 23.97  (5.72)
M3 (n=289, 290) -0.57  (1.60) -0.32  (1.62)
M6 (n=278, 280) -0.56  (1.62) -0.44  (1.73)
M9 (n=266, 272) -0.67  (1.78) -0.72  (1.77)
M12 (n=258, 263) -0.72  (1.86) -0.41  (1.87)
M15 (n=246, 248) -0.81  (1.83) -0.56  (1.96)
M18 (n=237, 232) -0.86  (1.95) -0.65  (1.92)
M21 (n=231, 231) -0.89  (1.98) -0.67  (1.92)
M24 (n=221, 223) -0.74  (2.10) -0.81  (2.06)
FU M1 (n=247, 220) -0.46  (2.05) -1.02  (2.01)
FU M3 (n=247, 231) -0.58  (2.07) -0.90  (2.15)
FU M6 (n=241, 219) -0.64  (2.15) -0.95  (2.11)
Ext M1 (n=159, 161) -1.01  (2.08) -1.09  (2.15)
Ext M3 (n=157, 157) -1.07  (2.10) -1.16  (2.45)
Ext M6 (n=148, 157) -1.48  (1.87) -1.26  (2.38)
Ext M9 (n=143, 155) -1.15  (2.31) -1.36  (2.54)
Ext M12 (n=141, 155) -1.49  (2.22) -1.59  (2.38)
Ext M15 (n=141, 142) -1.49  (2.25) -1.46  (2.41)
Ext M18 (n=132, 138) -1.54  (2.25) -1.63  (2.21)
Ext M21 (n=129, 142) -1.33  (2.45) -1.64  (2.45)
Ext M24 (n=124, 130) -1.39  (2.27) -1.46  (2.43)
Ext M27 (n=123, 124) -1.35  (2.48) -1.44  (2.41)
Ext M30 (n=124, 125) -1.75  (2.13) -1.62  (2.55)
Ext M33 (n=98, 113) -1.47  (2.05) -1.61  (2.25)
Ext M36 (n=52, 60) -1.22  (2.16) -1.87  (2.23)
Ext M36 [LOCF] (n=171, 169) -1.39  (2.31) -1.77  (2.46)
Ext FU M3 (n=118, 114) -1.12  (2.15) -1.69  (2.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.251
Confidence Interval 90%
-0.466 to -0.037
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.130
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.095
Confidence Interval 90%
-0.323 to 0.134
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.139
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.084
Confidence Interval 90%
-0.158 to 0.325
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.146
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.266
Confidence Interval 90%
-0.524 to -0.009
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.156
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.181
Confidence Interval 90%
-0.453 to 0.091
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.165
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.141
Confidence Interval 90%
-0.427 to 0.145
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.173
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.155
Confidence Interval 90%
-0.445 to 0.134
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.176
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.119
Confidence Interval 90%
-0.193 to 0.431
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.189
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.617
Confidence Interval 90%
0.322 to 0.911
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.179
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.354
Confidence Interval 90%
0.051 to 0.657
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.184
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.318
Confidence Interval 90%
0.011 to 0.626
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.186
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.136
Confidence Interval 90%
-0.227 to 0.500
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.220
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.098
Confidence Interval 90%
-0.289 to 0.485
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.235
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.202
Confidence Interval 90%
-0.576 to 0.172
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.226
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.245
Confidence Interval 90%
-0.180 to 0.669
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.257
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.126
Confidence Interval 90%
-0.284 to 0.535
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.248
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.023
Confidence Interval 90%
-0.395 to 0.441
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.253
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.146
Confidence Interval 90%
-0.262 to 0.554
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.247
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.321
Confidence Interval 90%
-0.138 to 0.780
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.278
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.043
Confidence Interval 90%
-0.419 to 0.506
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.280
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.190
Confidence Interval 90%
-0.279 to 0.659
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.284
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.117
Confidence Interval 90%
-0.579 to 0.346
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.280
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M33
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.262
Confidence Interval 90%
-0.189 to 0.714
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.273
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.267
Confidence Interval 90%
-0.370 to 0.904
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.383
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36 LOCF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.399
Confidence Interval 90%
-0.003 to 0.802
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.244
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.619
Confidence Interval 90%
0.137 to 1.102
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.292
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.
7.Primary Outcome
Title Summary of ≥ 20 % Decliners in DLco
Hide Description Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent 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 (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 308 303
Measure Type: Number
Unit of Measure: participants
M3 (n=289, 290) 0 2
M6 (n=278, 280) 1 2
M9 (n=266, 272) 0 3
M12 (n=258, 263) 4 3
M15 (n=246, 248) 1 2
M18(n=237, 232) 2 5
M21 (n=231, 231) 0 3
M24 (n=221, 223) 4 5
FU M1 (n=247, 220) 2 4
FU M3 (n=247, 231) 3 6
FU M6 (n=241, 219) 5 5
Ext M1 (n=159, 161) 3 3
Ext M3 (n=157, 157) 3 8
Ext M6 (n=148, 157) 4 6
Ext M9 (n=143, 155) 4 7
Ext M12 (n=141, 155) 8 9
Ext M15(n=141, 142) 4 6
Ext M18 (n=132, 138) 6 7
Ext M21(n=129, 142) 4 8
Ext M24 (n=124, 130) 5 7
Ext M27(n=123, 124) 7 8
Ext M30 (n=124, 125) 7 11
Ext M33(n=98, 113) 1 4
Ext M36 (n=52, 60) 2 3
Ext FU M3 (n=118, 114) 6 10
8.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide Description Forced Vital Capacity (FVC) measured in liters (L).
Time Frame Week -3 through extension follow up Month 3 or end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Total Lung Capacity (TLC)
Hide Description Total Lung Capacity measured in liters (L).
Time Frame Baseline through extension follow up Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Hide Description Change from baseline: mean of (value of observed HbA1c [%] at treatment 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 (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 315 303
Mean (Standard Deviation)
Unit of Measure: percent
Baseline (n=315, 303) 7.66  (1.12) 7.77  (1.12)
Week 6 (W6) (n=291, 280) -0.64  (0.67) -0.60  (0.70)
M3 (n=296, 291) -0.80  (0.86) -0.73  (0.89)
M6 (n=284, 287) -0.67  (0.94) -0.68  (1.00)
M9 (n=270, 280) -0.56  (0.98) -0.61  (0.93)
M12 (n=261, 263) -0.45  (0.94) -0.58  (1.00)
M15(n=252, 258) -0.43  (1.00) -0.51  (1.00)
M18(n=244, 241) -0.42  (1.02) -0.53  (1.06)
M21 (n=236, 238) -0.43  (1.04) -0.52  (1.02)
M24 (n=226, 234) -0.35  (1.09) -0.48  (1.13)
FU M3 (n=225, 226) -0.41  (1.04) -0.44  (1.06)
FU M6 (n=230, 230) -0.27  (1.12) -0.31  (1.06)
Ext M1 (n=167, 162) -0.41  (1.16) -0.40  (1.05)
Ext M3 (n=164, 162) -0.33  (1.19) -0.42  (1.05)
Ext M6 (n=157, 163) -0.26  (1.11) -0.40  (1.10)
Ext M9 (n=152, 157) -0.11  (1.15) -0.26  (1.13)
Ext M12 (n=150, 157) -0.08  (1.19) -0.17  (1.16)
Ext M15(n=146, 151) -0.17  (1.30) -0.25  (1.15)
Ext M18 (n=145, 145) -0.20  (1.19) -0.29  (1.17)
Ext M21(n=137, 147) -0.13  (1.16) -0.20  (1.20)
Ext M24 (n=131, 137) -0.18  (1.21) -0.23  (1.11)
Ext M27(n=129, 132) -0.18  (1.13) -0.28  (1.20)
Ext M30 (n=129, 129) -0.20  (1.19) -0.30  (1.19)
Ext M33(n=104, 116) 8.54  (88.44) -0.18  (1.17)
Ext M36 (n=55, 64) -0.20  (1.15) -0.30  (1.18)
Ext FU M3 (n=117, 116) -0.11  (1.40) -0.17  (1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.119
Confidence Interval 90%
-0.215 to -0.023
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.058
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.023
Confidence Interval 90%
-0.133 to 0.087
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.067
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.010
Confidence Interval 90%
-0.104 to 0.124
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.069
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.091
Confidence Interval 90%
-0.033 to 0.214
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.052
Confidence Interval 90%
-0.081 to 0.185
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.081
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.090
Confidence Interval 90%
-0.054 to 0.234
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.087
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.068
Confidence Interval 90%
-0.073 to 0.208
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.085
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.100
Confidence Interval 90%
-0.058 to 0.257
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.096
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.006
Confidence Interval 90%
-0.143 to 0.154
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.090
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.036
Confidence Interval 90%
-0.119 to 0.190
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.094
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.019
Confidence Interval 90%
-0.200 to 0.161
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.110
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.081
Confidence Interval 90%
-0.101 to 0.263
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.110
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.141
Confidence Interval 90%
-0.038 to 0.320
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.108
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.150
Confidence Interval 90%
-0.041 to 0.342
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.116
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.104
Confidence Interval 90%
-0.090 to 0.298
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.118
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.074
Confidence Interval 90%
-0.132 to 0.279
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.125
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.087
Confidence Interval 90%
-0.111 to 0.284
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.120
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.064
Confidence Interval 90%
-0.141 to 0.270
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.124
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.047
Confidence Interval 90%
-0.156 to 0.249
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.123
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.067
Confidence Interval 90%
-0.138 to 0.272
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.124
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.046
Confidence Interval 90%
-0.171 to 0.264
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.132
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M33
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.824
Confidence Interval 90%
-3.920 to 23.569
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.319
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.011
Confidence Interval 90%
-0.316 to 0.337
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.197
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.024
Confidence Interval 90%
-0.245 to 0.292
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.163
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.
11.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment 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; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 315 303
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=315, 303) 158.13  (42.71) 154.53  (41.51)
W6 (n=282, 276) -23.36  (51.69) -12.55  (50.46)
M3 (n=294, 290) -26.38  (52.72) -12.77  (54.93)
M6 (n=281, 285) -25.21  (53.48) -9.05  (68.42)
M9 (n=267, 279) -26.68  (54.95) -10.41  (56.42)
M12 (n=260, 263) -20.55  (59.68) -7.60  (60.03)
M15(n=253, 255) -21.37  (54.53) -8.82  (55.57)
M18(n=242, 238) -24.52  (54.50) -7.69  (58.47)
M21(n=232, 237) -25.95  (53.06) -13.14  (54.66)
M24 (n=226, 232) -24.02  (54.45) -8.91  (65.24)
FU M3 (n=5, 4) -22.60  (44.65) -4.08  (32.08)
FU M6 (n=161, 156) -2.85  (66.18) -1.56  (71.72)
Ext M1 (n=165, 162) -17.91  (60.96) -7.34  (60.98)
Ext M3 (n=162, 159) -18.16  (66.59) -9.29  (62.50)
Ext M6 (n=152, 161) -15.65  (67.18) -4.34  (61.96)
Ext M9 (n=149, 155) -13.99  (61.68) -6.06  (60.86)
Ext M12 (n=148, 155) -12.53  (72.25) -4.98  (62.92)
Ext M15(n=143, 143) -6.88  (68.85) -4.23  (65.21)
Ext M18 (n=136, 138) -17.23  (65.97) -10.32  (63.11)
Ext M21(n=132, 144) -12.86  (63.98) -6.53  (64.09)
Ext M24 (n=129, 136) -14.45  (61.65) -3.47  (68.57)
Ext M27 (n=128, 129) -21.68  (58.35) -3.76  (63.31)
Ext M30 (n=127, 130) -11.80  (62.82) -6.40  (61.47)
Ext M33(n=103, 115) -16.26  (63.44) -7.35  (66.21)
Ext M36 (n=55, 64) -28.61  (65.99) -13.35  (53.97)
Ext FU M3 (n=115, 118) -2.87  (81.19) 1.88  (64.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.39
Confidence Interval 90%
-19.07 to -5.710
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.054
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.21
Confidence Interval 90%
-22.11 to -6.312
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.795
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.96
Confidence Interval 90%
-19.07 to -2.852
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.920
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.56
Confidence Interval 90%
-20.89 to -4.232
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.052
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.83
Confidence Interval 90%
-80.69 to 47.019
Parameter Dispersion
Type: Standard Error of the mean
Value: 21.867
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.578
Confidence Interval 90%
-9.257 to 14.412
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.173
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.460
Confidence Interval 90%
-19.37 to 0.450
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.007
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.481
Confidence Interval 90%
-20.11 to 1.153
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.446
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.76
Confidence Interval 90%
-21.95 to 0.438
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.785
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.827
Confidence Interval 90%
-16.98 to 3.328
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.154
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.287
Confidence Interval 90%
-19.15 to 4.579
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.192
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.848
Confidence Interval 90%
-13.76 to 10.066
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.219
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.022
Confidence Interval 90%
-20.83 to 2.790
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.156
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.078
Confidence Interval 90%
-18.99 to 4.834
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.217
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.53
Confidence Interval 90%
-24.63 to -0.429
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.329
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.07
Confidence Interval 90%
-30.45 to -7.685
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.895
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.220
Confidence Interval 90%
-15.15 to 8.705
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.223
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M33
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.490
Confidence Interval 90%
-21.09 to 4.107
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.625
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.88
Confidence Interval 90%
-36.66 to -7.105
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.906
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.673
Confidence Interval 90%
-19.16 to 9.812
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.770
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.
12.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment 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; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Arm/Group Title Inhaled Insulin (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 314 302
Mean (Standard Deviation)
Unit of Measure: kg
Baseline (n=314, 302) 87.18  (14.75) 88.31  (15.50)
W4 (n=280, 270) 0.63  (2.11) 0.83  (1.86)
W8 (n=289, 281) 1.07  (2.41) 1.00  (2.31)
M3 (n=288, 290) 1.08  (2.75) 1.13  (2.55)
W18(n=280, 285) 1.33  (3.13) 1.76  (3.03)
M6 (n=276, 277) 1.15  (3.59) 1.89  (3.53)
M9 (n=269, 274) 1.50  (3.95) 2.15  (3.90)
M12 (n=259, 264) 1.75  (4.29) 2.37  (4.34)
M15(n=247, 249) 1.88  (4.33) 2.62  (4.49)
M18(n=237, 235) 1.79  (4.53) 2.93  (4.85)
M21(n=232, 232) 1.99  (4.56) 3.04  (5.04)
M24 (n=223, 226) 2.04  (4.86) 3.36  (5.16)
FU M3 (n=249, 231) 2.32  (5.25) 3.63  (5.34)
FU M6 (n=243, 218) 2.38  (5.34) 4.09  (7.70)
Ext M1 (n=161, 162) 2.87  (5.48) 3.75  (5.58)
Ext M3 (n=157, 157) 2.83  (4.78) 4.14  (5.69)
Ext M6 (n=148, 159) 3.15  (5.70) 4.01  (6.07)
Ext M9 (n=144, 156) 2.95  (5.95) 3.89  (5.87)
Ext M12 (n=144, 156) 2.96  (6.00) 4.19  (6.12)
Ext M15 (n=142, 145) 3.12  (5.91) 4.54  (6.26)
Ext M18 (n=135, 139) 3.33  (9.20) 4.46  (6.12)
Ext M21(n=132, 143) 2.79  (6.90) 5.01  (8.37)
Ext M24 (n=126, 131) 2.94  (6.98) 4.57  (6.37)
Ext M27(n=125, 125) 2.99  (6.94) 5.58  (9.62)
Ext M30 (n=125, 126) 3.39  (6.43) 4.78  (6.96)
Ext M33(n=99, 113) 2.77  (6.33) 5.22  (7.21)
Ext M36 (n=54, 60) 2.48  (6.61) 5.28  (7.09)
Ext FU M3 (n=119, 115) 2.74  (6.90) 4.44  (6.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.059
Confidence Interval 90%
-0.416 to 0.299
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.217
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.735
Confidence Interval 90%
-1.224 to -0.246
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.297
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.642
Confidence Interval 90%
-1.251 to -0.032
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.370
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.355
Confidence Interval 90%
-2.120 to -0.589
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.464
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.303
Confidence Interval 90%
-2.086 to -0.520
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.475
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments FU M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.557
Confidence Interval 90%
-2.539 to -0.575
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.596
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.904
Confidence Interval 90%
-1.898 to 0.090
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.603
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.280
Confidence Interval 90%
-2.225 to -0.334
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.573
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.834
Confidence Interval 90%
-1.909 to 0.241
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.652
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.001
Confidence Interval 90%
-2.080 to 0.078
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.654
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.316
Confidence Interval 90%
-2.431 to -0.200
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.676
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.512
Confidence Interval 90%
-2.661 to -0.363
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.696
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.313
Confidence Interval 90%
-2.824 to 0.198
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.916
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.399
Confidence Interval 90%
-3.891 to -0.907
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.904
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.566
Confidence Interval 90%
-2.867 to -0.265
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.788
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.720
Confidence Interval 90%
-4.439 to -1.001
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.041
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.401
Confidence Interval 90%
-2.755 to -0.047
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.820
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M33
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.281
Confidence Interval 90%
-3.781 to -0.782
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.908
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext M36
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.766
Confidence Interval 90%
-4.932 to -0.599
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.305
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin (Exubera®), Subcutaneous Insulin
Comments Ext FU M3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.637
Confidence Interval 90%
-3.120 to -0.153
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.898
Estimation Comments Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.
13.Secondary Outcome
Title Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Hide Description Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
Time Frame Month 3 through extension Month 36
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 (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 315 303
Mean (Standard Deviation)
Unit of Measure: units
M3 (n=301, 298) 44.10  (25.60) 47.98  (25.06)
M6 (n=289, 291) 44.03  (26.27) 47.31  (25.47)
M9 (n=275, 284) 43.64  (26.17) 48.11  (26.02)
M12 (n=266, 270) 44.62  (27.43) 48.01  (26.02)
M15 (n=258, 260) 45.02  (27.76) 48.37  (26.48)
M18 (n=243, 242) 46.07  (27.77) 48.93  (27.60)
M21 (n=240, 240) 46.67  (29.06) 49.84  (28.73)
M24 (n=229, 237) 46.62  (28.55) 50.34  (29.31)
Ext M1 (n=167, 164) 45.29  (28.00) 51.29  (28.45)
Ext M3 (n=165, 162) 45.76  (28.61) 51.62  (28.71)
Ext M6 (n=159, 164) 45.89  (28.61) 52.18  (28.85)
Ext M9 (n=156, 158) 46.51  (29.34) 52.32  (28.89)
Ext M12 (n=151, 158) 46.52  (29.84) 51.72  (29.06)
Ext M15 (n=148, 149) 46.39  (30.12) 52.92  (29.83)
Ext M18 (n=145, 145) 46.31  (31.17) 52.37  (29.78)
Ext M21 (n=137, 148) 46.49  (31.17) 52.68  (29.40)
Ext M24 (n=131, 137) 47.21  (32.42) 52.18  (30.33)
Ext M27 (n=132, 133) 48.13  (32.76) 52.42  (29.87)
Ext M30 (n=131, 130) 48.13  (33.41) 53.22  (29.85)
Ext M33 (n=104, 116) 48.38  (32.47) 51.93  (30.65)
Ext M36 (n=56, 65) 46.42  (31.91) 53.47  (28.96)
14.Secondary Outcome
Title Total Daily Long-acting Insulin (Adjusted for Body Weight)
Hide Description Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
Time Frame Month 3 through extension Month 36
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 (Exubera®) Subcutaneous Insulin
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 315 303
Mean (Standard Deviation)
Unit of Measure: units/kg
M3 (n=301, 298) 0.51  (0.29) 0.54  (0.27)
M6 (n=289, 291) 0.50  (0.29) 0.54  (0.28)
M9 (n=275, 284) 0.50  (0.29) 0.55  (0.29)
M12 (n=266, 270) 0.51  (0.30) 0.55  (0.29)
M15 (n=258, 260) 0.52  (0.31) 0.56  (0.30)
M18 (n=243, 242) 0.53  (0.31) 0.57  (0.31)
M21 (n=240, 240) 0.53  (0.32) 0.57  (0.32)
M24 (n=229, 237) 0.54  (0.32) 0.58  (0.32)
Ext M1 (n=167, 164) 0.53  (0.33) 0.59  (0.31)
Ext M3 (n=165, 162) 0.53  (0.34) 0.59  (0.31)
Ext M6 (n=159, 164) 0.54  (0.34) 0.60  (0.31)
Ext M9 (n=156, 158) 0.54  (0.35) 0.60  (0.31)
Ext M12 (n=151, 158) 0.54  (0.36) 0.60  (0.32)
Ext M15 (n=148, 149) 0.54  (0.36) 0.61  (0.32)
Ext M18 (n=145, 145) 0.54  (0.37) 0.61  (0.32)
Ext M21 (n=137, 148) 0.54  (0.37) 0.61  (0.32)
Ext M24 (n=131, 137) 0.55  (0.39) 0.61  (0.34)
Ext M27 (n=132, 133) 0.56  (0.39) 0.61  (0.33)
Ext M30 (n=131, 130) 0.56  (0.41) 0.62  (0.33)
Ext M33 (n=104, 116) 0.56  (0.37) 0.61  (0.34)
Ext M36 (n=56, 65) 0.53  (0.37) 0.61  (0.31)
15.Secondary Outcome
Title Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Hide Description Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.
Time Frame Month 3 through extension Month 36
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 (Exubera®) (mg) Subcutaneous Insulin (Units)
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 315 303
Mean (Standard Deviation)
Unit of Measure: mg, units
M3 (n=302, 299) 12.66  (6.80) 31.15  (18.75)
M6 (n=290, 292) 13.18  (6.90) 31.73  (19.08)
M9 (n=275, 285) 13.57  (7.57) 31.58  (18.89)
M12 (n=266, 270) 14.40  (7.90) 31.94  (19.29)
M15 (n=258, 261) 14.70  (8.06) 31.88  (19.37)
M18 (n=245, 242) 14.91  (8.41) 32.79  (20.70)
M21 (n=240, 242) 15.09  (8.55) 33.18  (20.92)
M24 (n=229, 238) 15.43  (8.65) 34.04  (21.84)
Ext M1 (n=167, 164) 13.89  (8.47) 34.52  (24.52)
Ext M3 (n=165, 163) 14.62  (9.18) 35.29  (23.19)
Ext M6 (n=159, 165) 14.62  (9.16) 35.43  (24.80)
Ext M9 (n=156, 161) 14.82  (9.10) 35.68  (24.72)
Ext M12 (n=151, 160) 15.42  (9.81) 36.56  (26.34)
Ext M15 (n=148, 151) 15.48  (9.90) 36.27  (25.51)
Ext M18 (n=145, 146) 15.57  (9.93) 37.37  (26.29)
Ext M21 (n=138, 149) 15.94  (10.41) 36.80  (27.09)
Ext M24 (n=131, 138) 15.46  (9.70) 38.51  (29.06)
Ext M27 (n=132, 134) 16.25  (10.30) 38.54  (28.13)
Ext M30 (n=131, 131) 16.56  (10.63) 39.01  (28.66)
Ext M33 (n=105, 117) 16.51  (10.43) 40.33  (30.81)
Ext M36 (n=56, 66) 17.25  (11.30) 42.34  (28.72)
16.Secondary Outcome
Title Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Hide Description Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).
Time Frame Month 3 through extension Month 36
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 (Exubera®) (mg) Subcutaneous Insulin (Units)
Hide Arm/Group Description:
Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
Overall Number of Participants Analyzed 315 303
Mean (Standard Deviation)
Unit of Measure: mg/kg, units/kg
M3 (n=302, 299) 0.15  (0.07) 0.36  (0.22)
M6 (n=290, 292) 0.15  (0.08) 0.36  (0.22)
M9 (n=275, 285) 0.16  (0.08) 0.36  (0.22)
M12 (n=266, 270) 0.17  (0.09) 0.37  (0.23)
M15 (n=258, 261) 0.17  (0.09) 0.37  (0.24)
M18 (n=245, 242) 0.17  (0.09) 0.38  (0.25)
M21 (n=240, 242) 0.17  (0.09) 0.39  (0.26)
M24 (n=229, 238) 0.18  (0.10) 0.40  (0.27)
Ext M1 (n=167, 164) 0.16  (0.09) 0.40  (0.30)
Ext M3 (n=165, 163) 0.17  (0.10) 0.41  (0.26)
Ext M6 (n=159, 165) 0.17  (0.10) 0.41  (0.30)
Ext M9 (n=156, 161) 0.17  (0.10) 0.42  (0.30)
Ext M12 (n=151, 160) 0.18  (0.11) 0.43  (0.32)