Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00138671
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : August 30, 2005
Results First Posted : November 13, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus
Chronic Obstructive Pulmonary Disease
Interventions Drug: Subcutaneous Insulin
Drug: Inhaled Insulin
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin. Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Period Title: Overall Study
Started 59 46
Completed 46 30
Not Completed 13 16
Reason Not Completed
Death             0             3
Adverse Event             6             3
Lost to Follow-up             1             2
Withdrawal by Subject             3             5
Other             3             3
Arm/Group Title Inhaled Insulin Subcutaneous Insulin Total
Hide Arm/Group Description Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin. Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin. Total of all reporting groups
Overall Number of Baseline Participants 59 46 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 46 participants 105 participants
36 to 45 years 1 3 4
46 to 55 years 10 4 14
56 to 65 years 20 23 43
66 to 75 years 27 15 42
> 75 years 1 1 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 46 participants 105 participants
Female
17
  28.8%
9
  19.6%
26
  24.8%
Male
42
  71.2%
37
  80.4%
79
  75.2%
Primary Diagnosis (Diabetes Type I or II)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 46 participants 105 participants
Type I 7 6 13
Type II 52 40 92
[1]
Measure Description: Type I or Type II diabetes mellitus was defined using the American Diabetes Association criteria (2002).
1.Primary Outcome
Title Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Hide Description FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).
Time Frame Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 59 43
Mean (Standard Deviation)
Unit of Measure: L
Week 1 (n=52, 39) -0.021  (0.132) -0.018  (0.125)
Week 2 (n=51, 40) -0.039  (0.116) -0.042  (0.120)
Week 3 (n=47, 40) -0.026  (0.121) -0.048  (0.145)
Week 4 (n=50, 38) -0.050  (0.140) -0.039  (0.151)
Week 6 (n=53, 38) -0.045  (0.152) -0.070  (0.165)
Week 12 (n=48, 41) -0.056  (0.180) -0.007  (0.187)
Week 18 (n=52, 37) -0.049  (0.158) -0.071  (0.195)
Week 26 (n=52, 38) -0.067  (0.174) -0.096  (0.189)
Week 39, (n=47, 34) -0.053  (0.174) -0.092  (0.232)
Week 52 (n=45, 30) -0.068  (0.208) -0.128  (0.184)
2.Primary Outcome
Title Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)
Hide Description DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).
Time Frame Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 59 43
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
Week 1 (n=51, 40) -0.263  (1.610) -0.319  (0.984)
Week 2 (n=51, 40) -0.491  (1.288) -0.031  (1.106)
Week 3 (n=47, 40) -0.494  (1.175) 0.169  (1.303)
Week 4 (n=50, 39) -0.640  (1.345) -0.482  (1.321)
Week 6 (n=52, 38) -0.625  (1.356) -0.576  (1.226)
Week 12 (n=47, 40) -0.379  (1.516) -0.534  (1.506)
Week 18 (n=51, 36) -0.287  (1.463) -0.286  (1.796)
Week 26 (n=52, 38) -0.287  (1.841) -0.947  (1.643)
Week 39 (n=47, 33) -0.611  (1.475) -0.891  (2.137)
Week 52 (n=45, 29) -0.614  (1.754) -0.882  (1.720)
3.Secondary Outcome
Title Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)
Hide Description Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)
Hide Description Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Other PFTs (Besides FEV1 and DLco)
Hide Description Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Bronchodilator Responsiveness as Determined by the Change in FEV1
Hide Description Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.
Time Frame Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 59 43
Mean (Standard Deviation)
Unit of Measure: percent change
Week 1 (n=52, 39) 4.890  (5.727) 5.693  (7.249)
Week 2 (n=51, 40) 6.132  (6.200) 5.245  (6.254)
Week 3 (n=47, 40) 6.346  (7.469) 5.820  (8.347)
Week 4 (n=50, 38) 5.177  (7.211) 6.382  (9.685)
Week 6 (n=53, 38) 5.988  (6.034) 7.736  (10.139)
Week 12 (n=48, 41) 6.473  (8.994) 5.542  (6.791)
Week 18 (n=52, 37) 6.700  (6.020) 5.152  (8.155)
Week 26 (n=52, 38) 5.585  (5.592) 5.856  (8.562)
Week 39 (n=47, 34) 6.634  (5.829) 6.098  (9.311)
Week 52 (n=45, 30) 6.030  (4.700) 5.445  (8.390)
7.Secondary Outcome
Title Insulin Dose Responsiveness for FEV1
Hide Description FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).
Time Frame Baseline, Week 9, Week 51
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 50 39
Mean (Standard Deviation)
Unit of Measure: L
Baseline, 10 minutes (n=50, 39) 0.009  (0.076) 0.022  (0.106)
Baseline, 60 minutes (n=50, 39) -0.004  (0.096) 0.020  (0.127)
Week 9, 10 minutes (n=42, 31) -0.004  (0.110) 0.016  (0.096)
Week 9, 60 minutes (n=42, 30) 0.011  (0.109) 0.030  (0.116)
Week 51, 10 minutes (n=46, 31) -0.021  (0.121) -0.002  (0.084)
Week 51, 60 minutes (n=45, 31) 0.005  (0.115) -0.020  (0.141)
8.Secondary Outcome
Title Insulin Dose Responsiveness for DLco
Hide Description DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).
Time Frame Baseline, Week 9, Week 51
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had a FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 48 39
Mean (Standard Deviation)
Unit of Measure: mL/min/mmHg
Baseline, 10 minutes (n=48, 39) -0.461  (1.157) -0.195  (0.707)
Baseline, 60 minutes (n=49, 39) -0.597  (1.102) -0.160  (1.217)
Week 9, 10 minutes (n=41, 30) -0.182  (1.015) -0.238  (1.505)
Week 9, 60 minutes (n=42, 29) 0.013  (2.288) -0.373  (1.574)
Week 51, 10 minutes (n=44, 31) -0.465  (0.781) 0.054  (1.204)
Week 51, 60 minutes (n=44, 31) -0.395  (0.885) -0.163  (1.211)
9.Secondary Outcome
Title Methacholine PC20
Hide Description Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used
Hide Description All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Hide Description Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.
Time Frame 0 to 1 week to > 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 59 43
Measure Type: Number
Unit of Measure: events/subject-month (crude event rate)
0 to 1 week (n=59, 43) 0.00 0.00
> 1 to 2 weeks (n=59, 43) 0.07 0.00
> 2 to 3 weeks (n=59, 43) 0.00 0.00
> 3 to 4 weeks (n=59, 42) 0.07 0.10
> 4 to 6 weeks (n=57, 42) 0.08 0.05
> 6 to 9 weeks (n=56, 42) 0.05 0.03
> 9 to 12 weeks (n=55, 41) 0.05 0.07
> 3 to 6 months (n=52, 41) 0.02 0.01
> 6 to 9 months (n=52, 37) 0.01 0.01
> 9 months (n=50, 35) 0.01 0.02
Overall (n=59, 43) 0.02 0.02
12.Secondary Outcome
Title Incidence of Severe COPD Exacerbations
Hide Description Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.
Time Frame 0 to 1 week to > 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 59 43
Measure Type: Number
Unit of Measure: events/subject-month (crude event rate)
0 to 1 week (n=59, 43) 0.00 0.00
> 1 to 2 weeks (n=59, 43) 0.00 0.00
> 2 to 3 weeks (n=59, 43) 0.00 0.00
> 3 to 4 weeks (n=59, 42) 0.00 0.00
> 4 to 6 weeks (n=57, 42) 0.00 0.00
> 6 to 9 weeks (n=56, 42) 0.00 0.00
> 9 to 12 weeks (n=55, 41) 0.00 0.00
> 3 to 6 months (n=52, 41) 0.00 0.00
> 6 to 9 months (n=52, 37) 0.01 0.00
> 9 months (n=50, 35) 0.00 0.00
Overall (n= 59, 43) 0.00 0.00
13.Secondary Outcome
Title Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires
Hide Description The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Hide Description Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).
Time Frame Baseline, Weeks 6, 12, 26, 39, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 57 43
Mean (Standard Deviation)
Unit of Measure: percent
Week 6 (n=56, 40) -0.40  (0.81) -0.48  (0.60)
Week 12 (n=50, 41) -0.53  (0.98) -0.42  (0.65)
Week 26 (n=52, 38) -0.39  (0.96) -0.32  (0.79)
Week 39 (n=48, 35) -0.34  (1.11) -0.20  (1.01)
Week 52 (n=46, 32) -0.30  (1.10) -0.23  (0.84)
Week 52 LOCF (n=57, 43) -0.28  (1.03) -0.26  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval 90%
-0.17 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 90%
-0.27 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 90%
-0.29 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval 90%
-0.36 to 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval 90%
-0.23 to 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 LOCF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 90%
-0.29 to 0.31
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose
Hide Description Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).
Time Frame Baseline, Weeks 6, 12, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 57 43
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 6 (n=52, 39) -24.67  (69.69) 2.89  (41.17)
Week 12 (n=48, 39) -30.73  (52.99) -0.18  (46.25)
Week 26 (n=47, 38) -34.92  (61.63) 10.45  (62.80)
Week 39 (n=47, 33) -20.45  (56.62) 10.43  (98.53)
Week 52 (n=45, 31) -23.40  (65.77) 12.37  (58.01)
Week 52 (LOCF) (n=57, 43) -28.55  (65.85) 2.36  (66.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.475
Confidence Interval 90%
-23.47 to 14.518
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.91
Confidence Interval 90%
-30.04 to 8.232
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.84
Confidence Interval 90%
-42.51 to -3.166
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.222
Confidence Interval 90%
-28.52 to 12.075
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.329
Confidence Interval 90%
-29.27 to 12.616
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 LOCF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.406
Confidence Interval 90%
-13.70 to 16.514
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).
Time Frame Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=randomized subjects with >=1 study drug dose, baseline and >=1 post-baseline HbA1c measurement. Last Observation Carried Forward (LOCF) method used. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin. Week 11 and 50 visits were part of the methacholine substudy and were not required visits for all subjects.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 59 43
Mean (Standard Deviation)
Unit of Measure: kg
Week 1 (n=52, 40) 0.25  (1.62) 0.02  (0.98)
Week 2 (n=51, 40) 0.26  (1.77) 0.15  (1.73)
Week 3 (n=49, 41) 0.19  (2.03) 0.13  (1.90)
Week 4 (n=53, 41) 0.19  (1.98) 0.24  (2.13)
Week 6 (n=54, 39) 0.42  (2.26) 0.26  (1.94)
Week 9 (n=47, 34) 0.31  (2.93) 0.25  (2.31)
Week 11 (n=8, 8) 0.03  (2.25) -0.14  (2.97)
Week 12 (n=49, 41) 0.42  (3.29) 0.34  (3.69)
Week 18 (n=52, 37) 0.40  (3.66) 0.90  (4.01)
Week 26 (n=52, 38) 0.85  (3.95) 1.99  (4.03)
Week 39 (n=47, 34) 0.61  (4.37) 2.43  (5.21)
Week 50 (n=8, 6) 1.75  (4.90) 6.33  (9.06)
Week 51 (n=23, 17) 1.21  (4.82) 2.67  (3.28)
Week 52 (n=43, 27) 0.97  (5.65) 3.32  (4.68)
Week 52 LOCF (n=59, 43) 0.99  (4.20) 2.40  (4.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.884
Confidence Interval 90%
-0.317 to 2.084
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.470
Confidence Interval 90%
-0.728 to 1.668
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.382
Confidence Interval 90%
-0.815 to 1.579
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.405
Confidence Interval 90%
-0.793 to 1.602
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.562
Confidence Interval 90%
-0.642 to 1.766
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.416
Confidence Interval 90%
-0.809 to 1.641
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 11
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%
-1.416 to 1.454
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 12
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%
-1.127 to 1.308
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.309
Confidence Interval 90%
-1.551 to 0.934
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.869
Confidence Interval 90%
-2.123 to 0.384
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 39
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.664
Confidence Interval 90%
-2.968 to -0.360
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 50
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.116
Confidence Interval 90%
-3.829 to -0.403
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 51
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.801
Confidence Interval 90%
-3.204 to -0.397
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.026
Confidence Interval 90%
-3.384 to -0.668
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Inhaled Insulin, Subcutaneous Insulin
Comments Week 52 LOCF
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.451
Confidence Interval 90%
-3.003 to 0.101
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)
Hide Description Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.
Time Frame Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 43
Mean (Standard Deviation)
Unit of Measure: Units
Week 1 (n=53, 40) 43.78  (22.20) 48.18  (23.44)
Week 2 (n=50, 41) 44.96  (22.50) 48.04  (24.33)
Week 3 (n=51, 39) 47.04  (24.36) 50.53  (24.44)
Week 4 (n=52, 41) 47.50  (25.94) 50.30  (25.61)
Week 6 (n=54, 40) 49.56  (26.61) 51.34  (25.91)
Week 9 (n=47, 35) 48.68  (28.61) 56.72  (25.89)
Week 12 (n=51, 41) 49.23  (28.46) 52.32  (29.49)
Week 18 (n=51, 40) 50.87  (29.32) 53.83  (29.34)
Week 26 (n=51, 38) 50.47  (28.83) 55.78  (28.11)
Week 39 (n=49, 35) 49.99  (29.00) 53.10  (26.11)
Week 52 (n=48, 34) 50.66  (30.63) 53.39  (26.32)
18.Secondary Outcome
Title Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Hide Description Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.
Time Frame Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 56 41
Mean (Standard Deviation)
Unit of Measure: mg, Units
Week 1 (n=54, 40) 12.34  (5.26) 32.74  (21.59)
Week 2 (n=51, 41) 13.03  (6.63) 32.08  (22.25)
Week 3 (n=52, 39) 14.10  (6.89) 32.88  (21.60)
Week 4 (n=53, 41) 14.17  (7.28) 31.85  (22.29)
Week 6 (n=55, 40) 15.17  (7.20) 33.42  (22.72)
Week 9 (n=48, 35) 15.82  (7.41) 36.65  (22.94)
Week 12 (n=52, 41) 15.64  (7.80) 33.58  (23.94)
Week 18 (n=52, 40) 16.47  (7.48) 35.36  (26.06)
Week 26 (n=52, 38) 16.71  (8.05) 37.73  (26.14)
Week 39 (n=49, 35) 17.22  (8.60) 37.47  (26.20)
Week 52 (n=48, 34) 16.85  (9.52) 39.28  (25.13)
19.Secondary Outcome
Title Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)
Hide Description Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).
Time Frame Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 43
Mean (Standard Deviation)
Unit of Measure: Units/kg
Week 1 (n=51, 40) 0.46  (0.22) 0.48  (0.19)
Week 2 (n=50, 40) 0.47  (0.22) 0.48  (0.20)
Week 3 (n=49, 39) 0.50  (0.25) 0.50  (0.21)
Week 4 (n=50, 41) 0.49  (0.26) 0.50  (0.21)
Week 6 (n=53, 39) 0.52  (0.27) 0.51  (0.21)
Week 9 (n=46, 34) 0.50  (0.29) 0.57  (0.21)
Week 12 (n=49, 41) 0.51  (0.28) 0.52  (0.24)
Week 18 (n=51, 37) 0.53  (0.29) 0.55  (0.24)
Week 26 (n=51, 38) 0.52  (0.28) 0.55  (0.22)
Week 39 (n=47, 34) 0.51  (0.27) 0.54  (0.24)
Week 52, (n=43, 27) 0.52  (0.29) 0.56  (0.21)
20.Secondary Outcome
Title Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)
Hide Description Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg).
Time Frame Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 56 41
Mean (Standard Deviation)
Unit of Measure: mg/kg, Units/kg
Week 1 (n=52, 40) 0.13  (0.05) 0.33  (0.21)
Week 2 (n=51, 40) 0.14  (0.06) 0.33  (0.21)
Week 3 (n=49, 39) 0.15  (0.07) 0.33  (0.22)
Week 4 (n=51, 41) 0.15  (0.07) 0.32  (0.22)
Week 6 (n=54, 39) 0.16  (0.07) 0.34  (0.22)
Week 9 (n=47, 34) 0.17  (0.07) 0.36  (0.22)
Week 12 (n=49, 41) 0.17  (0.08) 0.34  (0.23)
Week 18 (n=52, 37) 0.17  (0.08) 0.37  (0.24)
Week 26 (n=52, 38) 0.18  (0.08) 0.38  (0.24)
Week 39 (n=47, 34) 0.18  (0.08) 0.38  (0.25)
Week 52 (n=43, 27) 0.18  (0.09) 0.40  (0.25)
21.Secondary Outcome
Title Lipids
Hide Description Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.
Time Frame Duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Hypoglycemic Event Rates
Hide Description A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.
Time Frame 0 to1 month to > 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 57 43
Measure Type: Number
Unit of Measure: events / subject-month
0 to 1 month (n=57, 43) 1.76 1.36
> 1 to 2 months (n=56, 42) 1.25 0.98
> 2 to 3 months (n=55, 42) 1.21 0.97
> 3 to 4 months (n=52, 41) 0.87 0.67
> 4 to 5 months (n=52, 40) 0.96 1.01
> 5 to 6 months (n=52, 38) 0.69 1.13
> 6 to 7 months (n=52, 37) 0.62 0.92
> 7 to 8 months (n=51, 36) 0.67 0.75
> 8 to 9 months (n=51, 36) 0.59 0.78
> 9 to 10 months (n=51, 36) 0.50 0.52
> 10 to 11 months (n=49, 34) 0.75 0.51
> 11 months (n=47, 33) 0.62 0.26
Overall (n=57, 43) 0.89 0.84
23.Secondary Outcome
Title Severe Hypoglcyemic Event Rates
Hide Description An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.
Time Frame 0 to 1 month to > 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description:
Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
Overall Number of Participants Analyzed 57 43
Measure Type: Number
Unit of Measure: events / 100 subject-months
0 to 1 month (n=57, 43) 1.71 2.35
> 1 to 2 months (n=56, 42) 1.79 0.00
> 2 to 3 months (n=55, 42) 0.00 0.00
> 3 to 4 months (n=52, 41) 0.00 0.00
> 4 to 5 months (n=52, 40) 0.00 0.00
> 5 to 6 months (n=52, 38) 0.00 0.00
> 6 to 7 months (n=52, 37) 0.00 0.00
> 7 to 8 months (n=51, 36) 0.00 0.00
> 8 to 9 months (n=51, 36) 1.96 0.00
> 9 to 10 months (n=51, 36) 2.01 0.00
> 10 to 11 months (n=49, 34) 0.00 0.00
> 11 months (n=47, 33) 0.00 0.00
Overall (n=57, 43) 0.64 0.22
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inhaled Insulin Subcutaneous Insulin
Hide Arm/Group Description Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin. Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
All-Cause Mortality
Inhaled Insulin Subcutaneous Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Inhaled Insulin Subcutaneous Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   17   14 
Blood and lymphatic system disorders     
Anaemia  1  1/59 (1.69%)  0/46 (0.00%) 
Cardiac disorders     
Angina unstable   1/59 (1.69%)  0/46 (0.00%) 
Coronary artery disease   0/59 (0.00%)  2/46 (4.35%) 
Myocardial infarction   1/59 (1.69%)  3/46 (6.52%) 
Gastrointestinal disorders     
Inguinal hernia   0/59 (0.00%)  1/46 (2.17%) 
Intestinal obstruction   0/59 (0.00%)  1/46 (2.17%) 
Nausea   0/59 (0.00%)  1/46 (2.17%) 
Vomiting projectile   0/59 (0.00%)  1/46 (2.17%) 
General disorders     
Chest pain   1/59 (1.69%)  0/46 (0.00%) 
Hypothermia   0/59 (0.00%)  1/46 (2.17%) 
Ill-defined disorder   0/59 (0.00%)  1/46 (2.17%) 
Implant site erosion   1/59 (1.69%)  0/46 (0.00%) 
Infections and infestations     
Appendicitis   0/59 (0.00%)  1/46 (2.17%) 
Cellulitis   1/59 (1.69%)  0/46 (0.00%) 
Gastroenteritis viral   0/59 (0.00%)  1/46 (2.17%) 
Osteomyelitis   0/59 (0.00%)  1/46 (2.17%) 
Pneumonia   3/59 (5.08%)  0/46 (0.00%) 
Postoperative wound infection   1/59 (1.69%)  0/46 (0.00%) 
Injury, poisoning and procedural complications     
Drug administration error   0/59 (0.00%)  1/46 (2.17%) 
Radius fracture   1/59 (1.69%)  0/46 (0.00%) 
Rib fracture   1/59 (1.69%)  0/46 (0.00%) 
Wrist fracture   1/59 (1.69%)  0/46 (0.00%) 
Investigations     
Electrocardiogram abnormal   0/59 (0.00%)  1/46 (2.17%) 
Troponin increased   0/59 (0.00%)  1/46 (2.17%) 
Metabolism and nutrition disorders     
Dehydration   1/59 (1.69%)  0/46 (0.00%) 
Diabetic ketoacidosis   1/59 (1.69%)  0/46 (0.00%) 
Hypoglycaemia   1/59 (1.69%)  1/46 (2.17%) 
Ketoacidosis   1/59 (1.69%)  0/46 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain   0/59 (0.00%)  1/46 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung adenocarcinoma metastatic   1/59 (1.69%)  0/46 (0.00%) 
Rectal cancer   1/59 (1.69%)  0/46 (0.00%) 
Nervous system disorders     
Depressed level of consciousness   1/59 (1.69%)  0/46 (0.00%) 
Neuropathy peripheral   1/59 (1.69%)  0/46 (0.00%) 
Syncope   0/59 (0.00%)  1/46 (2.17%) 
Renal and urinary disorders     
Azotaemia   0/59 (0.00%)  1/46 (2.17%) 
Bladder neck obstruction   0/59 (0.00%)  1/46 (2.17%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   2/59 (3.39%)  0/46 (0.00%) 
Vascular disorders     
Arteriosclerosis   1/59 (1.69%)  0/46 (0.00%) 
Hypertension   0/59 (0.00%)  1/46 (2.17%) 
Hypotension   1/59 (1.69%)  0/46 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inhaled Insulin Subcutaneous Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   59   38 
Blood and lymphatic system disorders     
Anaemia  1  4/59 (6.78%)  1/46 (2.17%) 
Cardiac disorders     
Coronary artery disease   2/59 (3.39%)  3/46 (6.52%) 
Myocardial infarction   1/59 (1.69%)  3/46 (6.52%) 
Eye disorders     
Vision blurred   2/59 (3.39%)  4/46 (8.70%) 
Gastrointestinal disorders     
Constipation   3/59 (5.08%)  0/46 (0.00%) 
Diarrhoea   4/59 (6.78%)  3/46 (6.52%) 
Nausea   4/59 (6.78%)  4/46 (8.70%) 
Toothache   3/59 (5.08%)  1/46 (2.17%) 
Vomiting   3/59 (5.08%)  3/46 (6.52%) 
General disorders     
Asthenia   9/59 (15.25%)  5/46 (10.87%) 
Chest pain   4/59 (6.78%)  1/46 (2.17%) 
Fatigue   6/59 (10.17%)  3/46 (6.52%) 
Oedema peripheral   5/59 (8.47%)  6/46 (13.04%) 
Immune system disorders     
Seasonal allergy   3/59 (5.08%)  0/46 (0.00%) 
Infections and infestations     
Bronchitis   8/59 (13.56%)  2/46 (4.35%) 
Gastroenteritis   3/59 (5.08%)  0/46 (0.00%) 
Gastroenteritis viral   2/59 (3.39%)  3/46 (6.52%) 
Influenza   4/59 (6.78%)  2/46 (4.35%) 
Nasopharyngitis   10/59 (16.95%)  6/46 (13.04%) 
Otitis media   3/59 (5.08%)  1/46 (2.17%) 
Pneumonia   4/59 (6.78%)  2/46 (4.35%) 
Sinusitis   3/59 (5.08%)  2/46 (4.35%) 
Upper respiratory tract infection   12/59 (20.34%)  6/46 (13.04%) 
Urinary tract infection   4/59 (6.78%)  1/46 (2.17%) 
Injury, poisoning and procedural complications     
Contusion   3/59 (5.08%)  2/46 (4.35%) 
Metabolism and nutrition disorders     
Hypoglycaemia   40/59 (67.80%)  30/46 (65.22%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   7/59 (11.86%)  2/46 (4.35%) 
Back pain   5/59 (8.47%)  5/46 (10.87%) 
Musculoskeletal pain   2/59 (3.39%)  5/46 (10.87%) 
Myalgia   0/59 (0.00%)  3/46 (6.52%) 
Pain in extremity   3/59 (5.08%)  3/46 (6.52%) 
Nervous system disorders     
Dizziness   8/59 (13.56%)  7/46 (15.22%) 
Headache   10/59 (16.95%)  3/46 (6.52%) 
Neuropathy peripheral   4/59 (6.78%)  3/46 (6.52%) 
Tremor   4/59 (6.78%)  5/46 (10.87%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   4/59 (6.78%)  4/46 (8.70%) 
Cough   5/59 (8.47%)  2/46 (4.35%) 
Dyspnoea   6/59 (10.17%)  2/46 (4.35%) 
Productive cough   3/59 (5.08%)  0/46 (0.00%) 
Pulmonary congestion   3/59 (5.08%)  1/46 (2.17%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis   7/59 (11.86%)  9/46 (19.57%) 
Vascular disorders     
Hypertension   6/59 (10.17%)  3/46 (6.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v12.0)
This study was terminated due to Pfizer's decision to stop marketing Exubera®. Due to inconsistency in concomitant medication data entry, interpretation of the event rates for non-severe exacerbations may be of limited clinical value.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00138671     History of Changes
Other Study ID Numbers: A2171030
First Submitted: August 26, 2005
First Posted: August 30, 2005
Results First Submitted: September 2, 2009
Results First Posted: November 13, 2009
Last Update Posted: February 2, 2010