Trial Outcomes & Findings for Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes (NCT NCT00137046)
NCT ID: NCT00137046
Last Updated: 2010-02-18
Results Overview
Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation \[FEV1\] in liters \[L\] at observation minus Baseline value).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
582 participants
Primary outcome timeframe
Baseline through Extension Follow-up Month 3
Results posted on
2010-02-18
Participant Flow
A total of 64 centers took part in the study between 09 May 2002 and 08 December 2008.
At the screening visit and during the 4-week run-in phase all subjects received a subcutaneous insulin regimen consisting of 2 to 3 doses per day of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 doses daily of intermediate-/long-acting insulin (NPH insulin or Ultralente), or insulin glargine once daily at bedtime.
Participant milestones
| Measure |
Inhaled Insulin
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Overall Study
STARTED
|
291
|
291
|
|
Overall Study
Received Study Treatment
|
290
|
290
|
|
Overall Study
COMPLETED
|
192
|
198
|
|
Overall Study
NOT COMPLETED
|
99
|
93
|
Reasons for withdrawal
| Measure |
Inhaled Insulin
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Adverse Event
|
16
|
5
|
|
Overall Study
Laboratory Abnormality
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
13
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
24
|
|
Overall Study
Other
|
23
|
19
|
|
Overall Study
Withdrawal by Subject
|
33
|
42
|
|
Overall Study
Adverse Event 4 Days after Last Dose
|
1
|
0
|
|
Overall Study
Withdrew prior to study treatment
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Inhaled Insulin
n=290 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=290 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
Total
n=580 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 25
|
48 years
n=5 Participants
|
53 years
n=7 Participants
|
101 years
n=5 Participants
|
|
Age, Customized
26 to 35
|
81 years
n=5 Participants
|
96 years
n=7 Participants
|
177 years
n=5 Participants
|
|
Age, Customized
36 to 45
|
94 years
n=5 Participants
|
71 years
n=7 Participants
|
165 years
n=5 Participants
|
|
Age, Customized
46 to 55
|
52 years
n=5 Participants
|
48 years
n=7 Participants
|
100 years
n=5 Participants
|
|
Age, Customized
56 to 65
|
15 years
n=5 Participants
|
22 years
n=7 Participants
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Extension Follow-up Month 3Population: Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.
Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation \[FEV1\] in liters \[L\] at observation minus Baseline value).
Outcome measures
| Measure |
Inhaled Insulin
n=283 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=281 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Baseline (n=283, 281)
|
3.51 liters
Standard Deviation 0.76
|
3.47 liters
Standard Deviation 0.78
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 3 (n=277, 263)
|
-0.04 liters
Standard Deviation 0.12
|
-0.01 liters
Standard Deviation 0.12
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 6 (n=262, 273)
|
-0.05 liters
Standard Deviation 0.14
|
-0.03 liters
Standard Deviation 0.13
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 9 (n=251, 264)
|
-0.06 liters
Standard Deviation 0.14
|
-0.04 liters
Standard Deviation 0.13
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 12 (n=242, 259)
|
-0.08 liters
Standard Deviation 0.14
|
-004 liters
Standard Deviation 0.13
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 15 (n=236, 250)
|
-0.09 liters
Standard Deviation 0.16
|
-0.05 liters
Standard Deviation 0.15
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 18 (n=227, 232)
|
-0.09 liters
Standard Deviation 0.15
|
-0.06 liters
Standard Deviation 0.15
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 21 (n=218, 224)
|
-0.11 liters
Standard Deviation 0.16
|
-0.06 liters
Standard Deviation 0.15
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Month 24 (n=211, 219)
|
-0.12 liters
Standard Deviation 0.17
|
-0.08 liters
Standard Deviation 0.16
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Follow-up Month 1 (n=242, 209)
|
-0.11 liters
Standard Deviation 0.17
|
-0.09 liters
Standard Deviation 0.16
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Follow-up Month 3 (n=249, 225)
|
-0.10 liters
Standard Deviation 0.16
|
-0.09 liters
Standard Deviation 0.15
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Follow-up Month 6 (n=240, 218)
|
-0.10 liters
Standard Deviation 0.17
|
-0.09 liters
Standard Deviation 0.16
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 1 (n=166, 175)
|
-0.14 liters
Standard Deviation 0.20
|
-0.10 liters
Standard Deviation 0.17
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 3 (n=161, 175)
|
-0.14 liters
Standard Deviation 0.18
|
-0.10 liters
Standard Deviation 0.18
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 6 (n=158, 170)
|
-0.15 liters
Standard Deviation 0.19
|
-0.11 liters
Standard Deviation 0.17
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 9 (n=151, 164)
|
-0.16 liters
Standard Deviation 0.18
|
-0.12 liters
Standard Deviation 0.19
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 12 (n=152,161)
|
-0.17 liters
Standard Deviation 0.19
|
-0.11 liters
Standard Deviation 0.16
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 15 (n=153,162)
|
-0.16 liters
Standard Deviation 0.19
|
-0.12 liters
Standard Deviation 0.17
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 18 (n=148,160)
|
-0.18 liters
Standard Deviation 0.20
|
-0.14 liters
Standard Deviation 0.19
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 21 (n=144,158)
|
-0.17 liters
Standard Deviation 0.19
|
-0.15 liters
Standard Deviation 0.20
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 24 (n=141,153)
|
-0.18 liters
Standard Deviation 0.20
|
-0.14 liters
Standard Deviation 0.20
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 27 (n=136,146)
|
-0.19 liters
Standard Deviation 0.20
|
-0.13 liters
Standard Deviation 0.19
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 30 (n=136,147)
|
-0.20 liters
Standard Deviation 0.20
|
-0.16 liters
Standard Deviation 0.19
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 33 (n=127,139)
|
-0.20 liters
Standard Deviation 0.21
|
-0.17 liters
Standard Deviation 0.19
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 36 (n=105,126)
|
-0.23 liters
Standard Deviation 0.22
|
-0.16 liters
Standard Deviation 0.18
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 39 (n=52, 64)
|
-0.21 liters
Standard Deviation 0.23
|
-0.17 liters
Standard Deviation 0.21
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Month 39 (LOCF) (n=177, 187)
|
-0.22 liters
Standard Deviation 0.21
|
-0.15 liters
Standard Deviation 0.19
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Extension Follow Up Month 3 (n=115,102)
|
-0.20 liters
Standard Deviation 0.20
|
-0.17 liters
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: Month 3 through Extension Follow-up 3Population: FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.
Outcome measures
| Measure |
Inhaled Insulin
n=283 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=281 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 3 (n=277, 263)
|
0 participants
|
0 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 6 (n=262, 273)
|
0 participants
|
0 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 9 (n=251, 264)
|
0 participants
|
1 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 12 (n=242, 259)
|
1 participants
|
0 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 15 (n=236, 250)
|
3 participants
|
1 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 18 (n=227, 232)
|
0 participants
|
3 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 21 (n=218, 224)
|
2 participants
|
3 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Month 24 (n=211, 219)
|
3 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Follow-up Month 1 (n=242, 209)
|
2 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Follow-up Month 3 (n=249, 225)
|
3 participants
|
3 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Follow-up Month 6 (n=240, 218)
|
5 participants
|
1 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 1 (n=166, 175)
|
2 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 3 (n=161, 175)
|
4 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 6 (n=158, 170)
|
2 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 9 (n=151, 164)
|
3 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 12 (n=152, 161)
|
2 participants
|
0 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 15 (n=153, 162)
|
1 participants
|
0 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 18 (n=148, 160)
|
4 participants
|
3 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 21 (n=144, 158)
|
4 participants
|
5 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 24 (n=141, 153)
|
3 participants
|
5 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 27 (n=136, 146)
|
6 participants
|
4 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 30 (n=136, 147)
|
6 participants
|
2 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 33 (n=127, 139)
|
4 participants
|
3 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 36 (n=105, 126)
|
7 participants
|
3 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Month 39 (n=52, 64)
|
2 participants
|
1 participants
|
|
Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)
Extension Follow Up Month 3 (n=115, 102)
|
5 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline through Extension Follow-up Month 3Population: FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Due to study termination, originally planned inferential analysis change from Month 3 to extension Month 60 was not done.
Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity \[DLco\] measured in milliters/minutes/millimeters of mercury \[mL/min/mmHg\] at observation minus Baseline value).
Outcome measures
| Measure |
Inhaled Insulin
n=283 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=281 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 21 (n=218, 224)
|
-1.29 mL/min/mmHg
Standard Deviation 2.49
|
-0.56 mL/min/mmHg
Standard Deviation 2.07
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 24 (n=208, 219)
|
-1.28 mL/min/mmHg
Standard Deviation 2.29
|
-0.71 mL/min/mmHg
Standard Deviation 2.40
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 30 (n=135,146)
|
-1.36 mL/min/mmHg
Standard Deviation 2.54
|
-0.75 mL/min/mmHg
Standard Deviation 2.59
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 33 (n=127,139)
|
-1.31 mL/min/mmHg
Standard Deviation 2.54
|
-0.81 mL/min/mmHg
Standard Deviation 2.55
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 36 (n=105,122)
|
-1.53 mL/min/mmHg
Standard Deviation 2.53
|
-0.96 mL/min/mmHg
Standard Deviation 2.82
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 39 (n=52, 64)
|
-2.02 mL/min/mmHg
Standard Deviation 3.72
|
-0.93 mL/min/mmHg
Standard Deviation 2.59
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 39 (LOCF) (n=177, 187)
|
-1.66 mL/min/mmHg
Standard Deviation 2.90
|
-0.90 mL/min/mmHg
Standard Deviation 2.55
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Baseline (n=283, 281)
|
28.09 mL/min/mmHg
Standard Deviation 6.20
|
27.18 mL/min/mmHg
Standard Deviation 6.40
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 3 (n=277, 264)
|
-1.09 mL/min/mmHg
Standard Deviation 1.73
|
-0.29 mL/min/mmHg
Standard Deviation 1.71
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 6 (n=262, 273)
|
-1.17 mL/min/mmHg
Standard Deviation 2.16
|
-0.26 mL/min/mmHg
Standard Deviation 1.85
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 9 (n=250, 266)
|
-1.16 mL/min/mmHg
Standard Deviation 2.09
|
-0.41 mL/min/mmHg
Standard Deviation 1.91
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 12 (n=241, 258)
|
-1.40 mL/min/mmHg
Standard Deviation 2.15
|
-0.41 mL/min/mmHg
Standard Deviation 2.15
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 15 (n=235, 249)
|
-1.16 mL/min/mmHg
Standard Deviation 2.17
|
-0.42 mL/min/mmHg
Standard Deviation 2.17
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Month 18 (n=227, 232)
|
-1.21 mL/min/mmHg
Standard Deviation 2.28
|
-0.45 mL/min/mmHg
Standard Deviation 2.22
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Follow-up Month 1 (n=242,208)
|
-0.81 mL/min/mmHg
Standard Deviation 2.20
|
-0.81 mL/min/mmHg
Standard Deviation 2.42
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Follow-up Month 3 (n=247,225)
|
-0.77 mL/min/mmHg
Standard Deviation 2.46
|
-0.80 mL/min/mmHg
Standard Deviation 2.10
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Follow-up Month 6 (n=240,218)
|
-0.77 mL/min/mmHg
Standard Deviation 2.36
|
-0.67 mL/min/mmHg
Standard Deviation 2.28
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 1 (n=166,175)
|
-1.15 mL/min/mmHg
Standard Deviation 2.54
|
-0.55 mL/min/mmHg
Standard Deviation 2.35
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 3 (n=161,173)
|
-1.43 mL/min/mmHg
Standard Deviation 2.37
|
-0.73 mL/min/mmHg
Standard Deviation 2.45
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 6 (n=158,169)
|
-1.38 mL/min/mmHg
Standard Deviation 2.37
|
-0.78 mL/min/mmHg
Standard Deviation 2.54
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 9 (n=151,163)
|
-1.17 mL/min/mmHg
Standard Deviation 2.52
|
-0.74 mL/min/mmHg
Standard Deviation 2.57
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 12 (n=152,161)
|
-1.70 mL/min/mmHg
Standard Deviation 2.46
|
-0.70 mL/min/mmHg
Standard Deviation 2.60
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 15 (n=143,160)
|
-1.70 mL/min/mmHg
Standard Deviation 2.27
|
-0.72 mL/min/mmHg
Standard Deviation 2.94
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 18 (n=148,159)
|
-1.67 mL/min/mmHg
Standard Deviation 2.36
|
-1.02 mL/min/mmHg
Standard Deviation 2.72
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 21 (n=144,156)
|
-1.51 mL/min/mmHg
Standard Deviation 2.59
|
-0.88 mL/min/mmHg
Standard Deviation 2.64
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 24 (n=140,152)
|
-1.63 mL/min/mmHg
Standard Deviation 2.46
|
-0.70 mL/min/mmHg
Standard Deviation 2.72
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Month 27 (n=136,144)
|
-1.25 mL/min/mmHg
Standard Deviation 2.65
|
-0.76 mL/min/mmHg
Standard Deviation 2.75
|
|
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Extension Follow Up Month 3 (n=115, 101)
|
-0.89 mL/min/mmHg
Standard Deviation 2.35
|
-1.11 mL/min/mmHg
Standard Deviation 2.59
|
PRIMARY outcome
Timeframe: Month 3 through Extension Follow-up Month 3Population: FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% \[(baseline observed value minus visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.
Outcome measures
| Measure |
Inhaled Insulin
n=283 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=281 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 12 (n=241, 258)
|
2 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 15 (n=235, 249)
|
1 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 18 (n=227, 232)
|
5 participants
|
4 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 21 (n=218, 224)
|
4 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 24 (n=208, 219)
|
2 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Follow-up Month 1 (n=242, 208)
|
3 participants
|
3 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 6 (n=158, 169)
|
4 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 9 (n=151, 163)
|
2 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 12 (n=152, 161)
|
5 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 15 (n=143, 160)
|
3 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 18 (n=148, 159)
|
1 participants
|
4 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 21 (n=144, 156)
|
5 participants
|
3 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 24 (n=140, 152)
|
5 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 27 (n=136, 144)
|
4 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 30 (n=135, 146)
|
4 participants
|
4 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 33 (n=127, 139)
|
3 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 36 (n=105, 122)
|
4 participants
|
7 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 3 (n=277, 264)
|
0 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 6 (n=262, 273)
|
1 participants
|
0 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Month 9 (n=250, 266)
|
2 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Follow-up Month 3 (n=247, 225)
|
1 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Follow-up Month 6 (n=240, 218)
|
1 participants
|
2 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 1 (n=166, 175)
|
5 participants
|
0 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 3 (n=161, 173)
|
4 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Month 39 (n=52, 64)
|
3 participants
|
1 participants
|
|
Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).
Extension Follow Up Month 3 (n=115, 101)
|
3 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Week -2 through Extension Follow-up Month 6 or end of studyPopulation: FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Annual Rate of Change in FEV1 were not summarized as planned.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week -2 through Extension Follow-up Month 6 or end of studyPopulation: FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the annual rate of change in DLco were not summarized as planned.
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Extension Follow-up Month 3Population: 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.
Change from Baseline: mean of (value of Glycosylated Hemoglobin \[HbA1c\] at observation minus Baseline value).
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 39 (n=55, 66)
|
0.30 percent
Standard Deviation 0.94
|
-0.09 percent
Standard Deviation 1.00
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline (n=288, 286)
|
7.41 percent
Standard Deviation 1.06
|
7.46 percent
Standard Deviation 1.06
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Week 6 (n=269, 256)
|
-0.40 percent
Standard Deviation 0.61
|
-0.43 percent
Standard Deviation 0.61
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 3 (n=276, 280)
|
-0.36 percent
Standard Deviation 0.78
|
-0.41 percent
Standard Deviation 0.73
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 6 (n=263, 274)
|
-0.21 percent
Standard Deviation 0.80
|
-0.36 percent
Standard Deviation 0.81
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 9 (n=253, 266)
|
-0.10 percent
Standard Deviation 0.84
|
-0.23 percent
Standard Deviation 0.81
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 12 (n=240, 262)
|
-0.04 percent
Standard Deviation 0.87
|
-0.32 percent
Standard Deviation 0.82
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 15 (n=236, 253)
|
-0.12 percent
Standard Deviation 0.85
|
-0.29 percent
Standard Deviation 0.90
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 18 (n=231, 237)
|
-0.11 percent
Standard Deviation 0.88
|
-0.30 percent
Standard Deviation 0.89
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 21 (n=223, 231)
|
-0.05 percent
Standard Deviation 0.92
|
-0.25 percent
Standard Deviation 0.92
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 24 (n=214, 225)
|
0.05 percent
Standard Deviation 0.91
|
-0.27 percent
Standard Deviation 0.83
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Follow-up Month 3 (n=205, 195)
|
-0.13 percent
Standard Deviation 0.87
|
-0.22 percent
Standard Deviation 0.83
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Follow-up Month 6 (n=219, 221)
|
-0.10 percent
Standard Deviation 0.87
|
-0.14 percent
Standard Deviation 0.87
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 1 (n=171, 177)
|
-0.09 percent
Standard Deviation 0.90
|
-0.23 percent
Standard Deviation 0.85
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 3 (n=170, 177)
|
0.12 percent
Standard Deviation 0.95
|
-0.17 percent
Standard Deviation 0.91
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 6 (n=166, 178)
|
0.21 percent
Standard Deviation 0.99
|
-0.19 percent
Standard Deviation 0.86
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 9 (n=159, 171)
|
0.26 percent
Standard Deviation 1.00
|
-0.06 percent
Standard Deviation 0.94
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 12 (n=158, 169)
|
0.39 percent
Standard Deviation 0.98
|
0.08 percent
Standard Deviation 0.87
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 15 (n=156, 167)
|
0.40 percent
Standard Deviation 1.05
|
0.17 percent
Standard Deviation 0.85
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 18 (n=153, 166)
|
0.32 percent
Standard Deviation 0.94
|
0.05 percent
Standard Deviation 0.86
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 21 (n=154, 161)
|
0.27 percent
Standard Deviation 0.99
|
0.00 percent
Standard Deviation 0.88
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 24 (n=149, 154)
|
0.29 percent
Standard Deviation 0.89
|
0.06 percent
Standard Deviation 0.91
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 27 (n=141, 151)
|
0.33 percent
Standard Deviation 0.97
|
0.10 percent
Standard Deviation 0.92
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 30 (n=140, 150)
|
0.33 percent
Standard Deviation 0.91
|
-0.01 percent
Standard Deviation 0.89
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 33 (n=131, 143)
|
0.40 percent
Standard Deviation 0.94
|
-0.08 percent
Standard Deviation 0.92
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Month 36 (n=108, 132)
|
0.30 percent
Standard Deviation 0.99
|
-0.03 percent
Standard Deviation 0.99
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Extension Follow-Up Month 3 (n=120, 107)
|
0.14 percent
Standard Deviation 1.00
|
0.12 percent
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Month 1 through Extension Month 39Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Hypoglycemic Event Rates
Month 1 (n=288, 286)
|
7.6 total events/subject months
|
6.3 total events/subject months
|
|
Hypoglycemic Event Rates
Month 2 (n=282, 286)
|
5.9 total events/subject months
|
5.5 total events/subject months
|
|
Hypoglycemic Event Rates
Month 3 (n=279, 285)
|
5.8 total events/subject months
|
5.3 total events/subject months
|
|
Hypoglycemic Event Rates
Month 4 (n=273, 282)
|
4.8 total events/subject months
|
4.6 total events/subject months
|
|
Hypoglycemic Event Rates
Month 5 (n=266, 280)
|
4.7 total events/subject months
|
4.4 total events/subject months
|
|
Hypoglycemic Event Rates
Month 6 (n=263, 277)
|
4.5 total events/subject months
|
4.2 total events/subject months
|
|
Hypoglycemic Event Rates
Month 7 (n=259, 275)
|
4.5 total events/subject months
|
4.3 total events/subject months
|
|
Hypoglycemic Event Rates
Month 8 (n=257, 273)
|
4.2 total events/subject months
|
3.8 total events/subject months
|
|
Hypoglycemic Event Rates
Month 9 (n=254, 272)
|
3.8 total events/subject months
|
3.7 total events/subject months
|
|
Hypoglycemic Event Rates
Month 10 (n=249, 270)
|
4.2 total events/subject months
|
3.9 total events/subject months
|
|
Hypoglycemic Event Rates
Month 11 (n=245, 269)
|
3.9 total events/subject months
|
3.4 total events/subject months
|
|
Hypoglycemic Event Rates
Month 12 (n=243, 267)
|
3.8 total events/subject months
|
3.8 total events/subject months
|
|
Hypoglycemic Event Rates
Month 13 (n=239, 265)
|
3.6 total events/subject months
|
3.5 total events/subject months
|
|
Hypoglycemic Event Rates
Month 14 (n=237, 260)
|
3.6 total events/subject months
|
3.6 total events/subject months
|
|
Hypoglycemic Event Rates
Month 15 (n=236, 258)
|
3.2 total events/subject months
|
3.3 total events/subject months
|
|
Hypoglycemic Event Rates
Month 16 (n=236, 256)
|
3.4 total events/subject months
|
3.5 total events/subject months
|
|
Hypoglycemic Event Rates
Month 17 (n=235, 252)
|
3.0 total events/subject months
|
3.1 total events/subject months
|
|
Hypoglycemic Event Rates
Month 18 (n=233, 250)
|
3.0 total events/subject months
|
3.1 total events/subject months
|
|
Hypoglycemic Event Rates
Month 19 (n=232, 250)
|
3.2 total events/subject months
|
3.0 total events/subject months
|
|
Hypoglycemic Event Rates
Month 20 (n=227, 245)
|
3.0 total events/subject months
|
3.2 total events/subject months
|
|
Hypoglycemic Event Rates
Month 21 (n=226, 244)
|
3.0 total events/subject months
|
3.0 total events/subject months
|
|
Hypoglycemic Event Rates
Month 22 (n=226, 243)
|
2.8 total events/subject months
|
3.1 total events/subject months
|
|
Hypoglycemic Event Rates
Month 23 (n=224, 238)
|
2.5 total events/subject months
|
2.9 total events/subject months
|
|
Hypoglycemic Event Rates
Month 24 (n=222, 229)
|
2.6 total events/subject months
|
2.5 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 1 (n=177, 187)
|
3.5 total events/subject months
|
2.9 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 2 (n=177, 187)
|
3.6 total events/subject months
|
2.7 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 3 (n=172, 185)
|
4.1 total events/subject months
|
2.9 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 4 (n=169, 182)
|
3.2 total events/subject months
|
2.6 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 5 (n=169, 182)
|
3.2 total events/subject months
|
2.8 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 6 (n=168, 182)
|
2.8 total events/subject months
|
2.5 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 7 (n=167, 181)
|
3.1 total events/subject months
|
2.5 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 8 (n=167, 178)
|
2.6 total events/subject months
|
2.8 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 9 (n=165, 177)
|
2.1 total events/subject months
|
2.6 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 10 (n=165, 176)
|
3.1 total events/subject months
|
2.6 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 11 (n=162, 175)
|
3.2 total events/subject months
|
2.2 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 12 (n=160, 175)
|
3.3 total events/subject months
|
2.5 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 13 (n=158, 174)
|
2.8 total events/subject months
|
2.6 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 14 (n=156, 173)
|
2.9 total events/subject months
|
2.7 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 15 (n=156, 173)
|
3.0 total events/subject months
|
2.3 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 16 (n=156, 172)
|
3.4 total events/subject months
|
2.4 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 17 (n=156, 172)
|
3.0 total events/subject months
|
2.3 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 18 (n=156, 172)
|
3.0 total events/subject months
|
2.2 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 19 (n=155, 172)
|
3.2 total events/subject months
|
2.6 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 20 (n=155, 170)
|
2.9 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 21 (n=155, 169)
|
2.8 total events/subject months
|
2.3 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 22 (n=155, 165)
|
2.8 total events/subject months
|
2.2 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 23 (n=152, 164)
|
3.3 total events/subject months
|
2.3 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 24 (n=152, 163)
|
2.9 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 25 (n=150, 162)
|
3.2 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 26 (n=149, 160)
|
2.7 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 27 (n=147, 159)
|
2.7 total events/subject months
|
1.9 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 28 (n=146, 158)
|
2.7 total events/subject months
|
2.3 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 29 (n=145, 155)
|
2.7 total events/subject months
|
2.0 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 30 (n=143, 153)
|
2.5 total events/subject months
|
1.9 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 31 (n=141, 153)
|
2.6 total events/subject months
|
2.2 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 32 (n=138, 152)
|
2.8 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 33 (n=136, 150)
|
2.3 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 34 (n=131, 148)
|
2.0 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 35 (n=122, 147)
|
1.8 total events/subject months
|
2.1 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 36 (n=113, 138)
|
1.9 total events/subject months
|
2.4 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 37 (n=88, 104)
|
1.5 total events/subject months
|
2.0 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 38 (n=66, 73)
|
1.8 total events/subject months
|
1.7 total events/subject months
|
|
Hypoglycemic Event Rates
Extension Month 39 (n=53, 64)
|
1.7 total events/subject months
|
1.4 total events/subject months
|
|
Hypoglycemic Event Rates
Overall Comparative (n=288, 286)
|
4.1 total events/subject months
|
3.9 total events/subject months
|
|
Hypoglycemic Event Rates
Overall Extension (n=177, 187)
|
2.8 total events/subject months
|
2.4 total events/subject months
|
SECONDARY outcome
Timeframe: Month 1 through Extension Month 39Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months \* 100.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Severe Hypoglycemic Event Rates
Extension Month 12 (n=160, 175)
|
1.4 events / subject months * 100
|
4.3 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 16 (n=156, 172)
|
0.7 events / subject months * 100
|
13.7 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 38 (n=66, 73)
|
0.0 events / subject months * 100
|
0.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 1 (n=288, 286)
|
10.2 events / subject months * 100
|
9.1 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 2 (n=282, 286)
|
7.9 events / subject months * 100
|
7.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 3 (n=279, 285)
|
6.5 events / subject months * 100
|
6.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 4 (n=273, 282)
|
3.4 events / subject months * 100
|
4.3 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 5 (n=266, 280)
|
0.0 events / subject months * 100
|
4.3 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 6 (n=263, 277)
|
3.8 events / subject months * 100
|
6.5 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 7 (n=259, 275)
|
2.3 events / subject months * 100
|
4.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 8 (n=257, 273)
|
2.0 events / subject months * 100
|
4.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 9 (n=254, 272)
|
4.0 events / subject months * 100
|
5.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 10 (n=249, 270)
|
0.8 events / subject months * 100
|
3.3 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 11 (n=245, 269)
|
2.1 events / subject months * 100
|
3.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 12 (n=243, 267)
|
2.5 events / subject months * 100
|
3.8 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 13 (n=239, 265)
|
1.3 events / subject months * 100
|
2.7 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 14 (n=237, 260)
|
1.3 events / subject months * 100
|
3.5 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 15 (n=236, 258)
|
1.7 events / subject months * 100
|
3.1 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 16 (n=236, 256)
|
2.6 events / subject months * 100
|
2.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 17 (n=235, 252)
|
3.9 events / subject months * 100
|
1.6 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 18 (n=233, 250)
|
2.6 events / subject months * 100
|
5.6 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 19 (n=232, 250)
|
0.4 events / subject months * 100
|
2.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 20 (n=227, 245)
|
0.4 events / subject months * 100
|
4.9 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 21 (n=226, 244)
|
1.8 events / subject months * 100
|
2.9 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 22 (n=226, 243)
|
0.9 events / subject months * 100
|
2.1 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 23 (n=224, 238)
|
0.9 events / subject months * 100
|
2.6 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Month 24 (n=222, 239)
|
0.8 events / subject months * 100
|
2.6 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 1 (n=177, 187)
|
3.9 events / subject months * 100
|
1.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 2 (n=177, 187)
|
4.0 events / subject months * 100
|
7.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 3 (n=172, 185)
|
4.0 events / subject months * 100
|
2.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 4 (n=169, 182)
|
1.4 events / subject months * 100
|
1.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 5 (n=169, 182)
|
2.7 events / subject months * 100
|
4.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 6 (n=168, 182)
|
0.0 events / subject months * 100
|
3.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 7 (n=167, 181)
|
0.7 events / subject months * 100
|
2.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 8 (n=167, 178)
|
0.0 events / subject months * 100
|
2.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 9 (n=165, 177)
|
2.1 events / subject months * 100
|
4.9 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 10 (n=165, 176)
|
0.0 events / subject months * 100
|
3.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 11 (n=162, 175)
|
2.8 events / subject months * 100
|
1.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 13 (n=158, 174)
|
0.7 events / subject months * 100
|
1.8 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 14 (n=156, 173)
|
1.4 events / subject months * 100
|
3.1 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 15 (n=156, 173)
|
1.4 events / subject months * 100
|
11.1 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 17 (n=156, 172)
|
0.7 events / subject months * 100
|
5.6 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 18 (n=156, 172)
|
0.0 events / subject months * 100
|
7.5 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 19 (n=155, 172)
|
1.4 events / subject months * 100
|
6.9 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 20 (n=155, 170)
|
2.1 events / subject months * 100
|
2.5 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 21 (n=155, 169)
|
1.4 events / subject months * 100
|
3.8 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 22 (n=155, 165)
|
2.1 events / subject months * 100
|
1.3 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 23 (n=152, 164)
|
1.4 events / subject months * 100
|
3.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 24 (n=152, 163)
|
0.7 events / subject months * 100
|
3.2 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 25 (n=150, 162)
|
1.5 events / subject months * 100
|
0.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 26 (n=149, 160)
|
2.2 events / subject months * 100
|
0.7 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 27 (n=147, 159)
|
0.7 events / subject months * 100
|
0.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 28 (n=146, 158)
|
0.0 events / subject months * 100
|
3.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 29 (n=145, 155)
|
0.0 events / subject months * 100
|
0.7 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 30 (n=143, 153)
|
0.8 events / subject months * 100
|
0.7 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 31 (n=141, 153)
|
3.1 events / subject months * 100
|
0.0 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 32 (n=138, 152)
|
0.0 events / subject months * 100
|
1.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 33 (n=136, 150)
|
2.4 events / subject months * 100
|
1.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 34 (n=131, 148)
|
0.8 events / subject months * 100
|
1.4 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 35 (n=122, 147)
|
0.0 events / subject months * 100
|
5.9 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 36 (n=113, 138)
|
1.0 events / subject months * 100
|
0.9 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 37 (n=88, 104)
|
0.0 events / subject months * 100
|
3.8 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Extension Month 39 (n=53, 64)
|
0.8 events / subject months * 100
|
1.7 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Overall Comparative (n=288, 286)
|
2.8 events / subject months * 100
|
4.1 events / subject months * 100
|
|
Severe Hypoglycemic Event Rates
Overall Extension (n=177, 187)
|
1.4 events / subject months * 100
|
3.3 events / subject months * 100
|
SECONDARY outcome
Timeframe: Baseline through Extension Follow-up Month 3Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Change from Baseline: mean of (value of fasting plasma glucose \[milligrams per deciliter (mg/dL)\] at observation minus Baseline value).
Outcome measures
| Measure |
Inhaled Insulin
n=286 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
Follow-up Month 3 (n=2, 2)
|
-43.50 mg/dL
Standard Deviation 85.09
|
46.67 mg/dL
Standard Deviation 24.04
|
|
Change From Baseline in Fasting Plasma Glucose
Follow-up Month 6 (n=159, 164)
|
3.45 mg/dL
Standard Deviation 80.26
|
1.46 mg/dL
Standard Deviation 85.49
|
|
Change From Baseline in Fasting Plasma Glucose
Baseline (n=286, 286)
|
171.24 mg/dL
Standard Deviation 63.20
|
170.06 mg/dL
Standard Deviation 55.20
|
|
Change From Baseline in Fasting Plasma Glucose
Week 6 (n=263, 250)
|
-26.04 mg/dL
Standard Deviation 84.79
|
-14.02 mg/dL
Standard Deviation 80.13
|
|
Change From Baseline in Fasting Plasma Glucose
Month 3 (n=267, 276)
|
-21.84 mg/dL
Standard Deviation 85.26
|
-6.15 mg/dL
Standard Deviation 79.08
|
|
Change From Baseline in Fasting Plasma Glucose
Month 6 (n=258, 271)
|
-31.48 mg/dL
Standard Deviation 81.62
|
-6.29 mg/dL
Standard Deviation 83.81
|
|
Change From Baseline in Fasting Plasma Glucose
Month 9 (n=243, 262)
|
-25.34 mg/dL
Standard Deviation 86.24
|
1.28 mg/dL
Standard Deviation 96.32
|
|
Change From Baseline in Fasting Plasma Glucose
Month 12 (n=232, 256)
|
-24.25 mg/dL
Standard Deviation 87.53
|
-4.95 mg/dL
Standard Deviation 85.96
|
|
Change From Baseline in Fasting Plasma Glucose
Month 15 (n=230, 251)
|
-34.75 mg/dL
Standard Deviation 83.72
|
5.96 mg/dL
Standard Deviation 89.39
|
|
Change From Baseline in Fasting Plasma Glucose
Month 18 (n=226, 236)
|
-24.13 mg/dL
Standard Deviation 86.44
|
-8.13 mg/dL
Standard Deviation 88.83
|
|
Change From Baseline in Fasting Plasma Glucose
Month 21 (n=216, 230)
|
-26.77 mg/dL
Standard Deviation 88.96
|
-11.62 mg/dL
Standard Deviation 82.98
|
|
Change From Baseline in Fasting Plasma Glucose
Month 24 (n=208, 222)
|
-18.36 mg/dL
Standard Deviation 92.92
|
1.25 mg/dL
Standard Deviation 84.87
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 1 (n=164, 171)
|
-25.52 mg/dL
Standard Deviation 90.15
|
-2.72 mg/dL
Standard Deviation 91.27
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 3 (n=167, 172)
|
-25.02 mg/dL
Standard Deviation 87.75
|
0.43 mg/dL
Standard Deviation 84.55
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 6 (n=164, 177)
|
-13.47 mg/dL
Standard Deviation 80.85
|
-12.56 mg/dL
Standard Deviation 86.93
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 9 (n=152, 170)
|
-16.19 mg/dL
Standard Deviation 94.12
|
-4.46 mg/dL
Standard Deviation 88.86
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 12 (n=155, 167)
|
-22.53 mg/dL
Standard Deviation 83.01
|
-5.15 mg/dL
Standard Deviation 81.38
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 15 (n=148, 163)
|
-26.11 mg/dL
Standard Deviation 85.78
|
-10.64 mg/dL
Standard Deviation 86.00
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 18 (n=148, 163)
|
-12.42 mg/dL
Standard Deviation 86.69
|
-2.32 mg/dL
Standard Deviation 84.41
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 21 (n=152, 157)
|
-24.75 mg/dL
Standard Deviation 87.29
|
4.86 mg/dL
Standard Deviation 89.31
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 24 (n=142, 148)
|
-20.46 mg/dL
Standard Deviation 86.45
|
-10.36 mg/dL
Standard Deviation 93.08
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 27 (n=140, 148)
|
-14.91 mg/dL
Standard Deviation 78.42
|
-2.86 mg/dL
Standard Deviation 91.97
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 30 (n=138, 147)
|
-17.16 mg/dL
Standard Deviation 86.47
|
-3.77 mg/dL
Standard Deviation 86.15
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 33 (n=129, 141)
|
-22.77 mg/dL
Standard Deviation 94.77
|
-12.12 mg/dL
Standard Deviation 88.26
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 36 (n=107, 132)
|
-20.00 mg/dL
Standard Deviation 81.03
|
-2.49 mg/dL
Standard Deviation 86.06
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Month 39 (n=55, 64)
|
-38.47 mg/dL
Standard Deviation 95.17
|
-1.57 mg/dL
Standard Deviation 78.47
|
|
Change From Baseline in Fasting Plasma Glucose
Extension Follow-Up Month 3 (n=118, 105)
|
1.97 mg/dL
Standard Deviation 95.39
|
3.25 mg/dL
Standard Deviation 84.53
|
SECONDARY outcome
Timeframe: Baseline through Extension Follow-up Month 3Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Change From Baseline Body Weight
Follow-up Month 3 (n=248, 225)
|
1.50 kilograms
Standard Deviation 4.24
|
2.31 kilograms
Standard Deviation 4.89
|
|
Change From Baseline Body Weight
Follow-up Month 6 (n=239, 219)
|
1.68 kilograms
Standard Deviation 4.28
|
2.17 kilograms
Standard Deviation 4.46
|
|
Change From Baseline Body Weight
Extension Month 21 (n=144, 158)
|
2.14 kilograms
Standard Deviation 5.63
|
3.72 kilograms
Standard Deviation 5.82
|
|
Change From Baseline Body Weight
Extension Month 24 (n=141, 153)
|
2.49 kilograms
Standard Deviation 5.98
|
4.23 kilograms
Standard Deviation 5.70
|
|
Change From Baseline Body Weight
Extension Month 27 (n=136, 146)
|
2.12 kilograms
Standard Deviation 5.87
|
3.96 kilograms
Standard Deviation 6.15
|
|
Change From Baseline Body Weight
Extension Month 30 (n=136, 147)
|
2.42 kilograms
Standard Deviation 6.25
|
4.80 kilograms
Standard Deviation 8.38
|
|
Change From Baseline Body Weight
Extension Month 33 (n=127, 139)
|
2.30 kilograms
Standard Deviation 5.96
|
5.28 kilograms
Standard Deviation 10.84
|
|
Change From Baseline Body Weight
Extension Month 36 (n=105, 126)
|
2.11 kilograms
Standard Deviation 6.24
|
3.87 kilograms
Standard Deviation 6.25
|
|
Change From Baseline Body Weight
Baseline (n=288, 286)
|
75.12 kilograms
Standard Deviation 13.57
|
73.72 kilograms
Standard Deviation 13.13
|
|
Change From Baseline Body Weight
Week 4 (n=257, 247)
|
0.30 kilograms
Standard Deviation 1.39
|
0.63 kilograms
Standard Deviation 3.01
|
|
Change From Baseline Body Weight
Week 8 (n=263, 262)
|
0.46 kilograms
Standard Deviation 1.88
|
0.67 kilograms
Standard Deviation 2.00
|
|
Change From Baseline Body Weight
Month 3 (n=273, 269)
|
0.13 kilograms
Standard Deviation 2.20
|
0.67 kilograms
Standard Deviation 2.35
|
|
Change From Baseline Body Weight
Week 18 (n=248, 260)
|
0.15 kilograms
Standard Deviation 2.60
|
1.00 kilograms
Standard Deviation 2.64
|
|
Change From Baseline Body Weight
Month 6 (n=259, 272)
|
0.11 kilograms
Standard Deviation 2.89
|
1.25 kilograms
Standard Deviation 3.08
|
|
Change From Baseline Body Weight
Month 9 (n=251, 266)
|
0.05 kilograms
Standard Deviation 3.28
|
1.41 kilograms
Standard Deviation 3.35
|
|
Change From Baseline Body Weight
Month 12 (n=242, 259)
|
0.37 kilograms
Standard Deviation 3.46
|
1.55 kilograms
Standard Deviation 3.59
|
|
Change From Baseline Body Weight
Month 15 (n=236, 250)
|
0.44 kilograms
Standard Deviation 3.57
|
1.84 kilograms
Standard Deviation 3.90
|
|
Change From Baseline Body Weight
Month 18 (n=227, 233)
|
0.57 kilograms
Standard Deviation 3.99
|
2.26 kilograms
Standard Deviation 4.30
|
|
Change From Baseline Body Weight
Month 21 (n=220, 224)
|
1.07 kilograms
Standard Deviation 4.22
|
2.35 kilograms
Standard Deviation 4.51
|
|
Change From Baseline Body Weight
Month 24 (n=211, 220)
|
0.99 kilograms
Standard Deviation 4.58
|
2.23 kilograms
Standard Deviation 4.58
|
|
Change From Baseline Body Weight
Extension Month 1 (n=166, 175)
|
2.44 kilograms
Standard Deviation 6.98
|
2.50 kilograms
Standard Deviation 4.93
|
|
Change From Baseline Body Weight
Extension Month 3 (n=161, 175)
|
1.73 kilograms
Standard Deviation 4.69
|
3.08 kilograms
Standard Deviation 7.17
|
|
Change From Baseline Body Weight
Extension Month 6 (n=158, 170)
|
1.67 kilograms
Standard Deviation 4.93
|
3.05 kilograms
Standard Deviation 4.75
|
|
Change From Baseline Body Weight
Extension Month 9 (n=153, 164)
|
1.61 kilograms
Standard Deviation 4.73
|
3.17 kilograms
Standard Deviation 5.27
|
|
Change From Baseline Body Weight
Extension Month 12 (n=152, 162)
|
2.11 kilograms
Standard Deviation 4.95
|
3.08 kilograms
Standard Deviation 4.93
|
|
Change From Baseline Body Weight
Extension Month 15 (n=153, 162)
|
2.01 kilograms
Standard Deviation 5.06
|
3.16 kilograms
Standard Deviation 5.21
|
|
Change From Baseline Body Weight
Extension Month 18 (n=149, 160)
|
2.31 kilograms
Standard Deviation 5.50
|
3.30 kilograms
Standard Deviation 5.82
|
|
Change From Baseline Body Weight
Extension Month 39 (n=52, 64)
|
1.58 kilograms
Standard Deviation 7.90
|
4.83 kilograms
Standard Deviation 6.75
|
|
Change From Baseline Body Weight
Extension Follow-Up Month 3 (n=116, 103)
|
2.49 kilograms
Standard Deviation 5.98
|
4.09 kilograms
Standard Deviation 6.34
|
SECONDARY outcome
Timeframe: Month 3 through Extension Month 39Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 3 (n=280, 285)
|
30.52 units
Standard Deviation 16.00
|
34.97 units
Standard Deviation 17.38
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 6 (n=271, 280)
|
30.57 units
Standard Deviation 16.48
|
35.37 units
Standard Deviation 17.72
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 9 (n=256, 269)
|
30.69 units
Standard Deviation 16.53
|
35.35 units
Standard Deviation 18.06
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 12 (n=243, 262)
|
30.65 units
Standard Deviation 17.29
|
35.42 units
Standard Deviation 18.00
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 15 (n=237, 255)
|
30.99 units
Standard Deviation 17.83
|
35.75 units
Standard Deviation 17.86
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 18 (n=234, 242)
|
30.97 units
Standard Deviation 17.86
|
36.35 units
Standard Deviation 18.13
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 21 (n=224, 233)
|
31.30 units
Standard Deviation 18.53
|
36.75 units
Standard Deviation 17.76
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Month 24 (n=218, 229)
|
31.82 units
Standard Deviation 19.36
|
36.21 units
Standard Deviation 18.02
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 1 (n=171, 178)
|
32.84 units
Standard Deviation 18.90
|
35.67 units
Standard Deviation 18.72
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 3 (n=170, 177)
|
32.45 units
Standard Deviation 18.91
|
35.10 units
Standard Deviation 18.07
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 6 (n=166, 179)
|
31.96 units
Standard Deviation 18.36
|
34.75 units
Standard Deviation 17.55
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 9 (n=160, 174)
|
32.73 units
Standard Deviation 19.24
|
35.22 units
Standard Deviation 17.41
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 12 (n=159, 169)
|
32.29 units
Standard Deviation 19.12
|
33.82 units
Standard Deviation 15.65
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 15 (n=156, 164)
|
32.02 units
Standard Deviation 18.61
|
35.52 units
Standard Deviation 18.37
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 18 (n=152, 166)
|
32.37 units
Standard Deviation 18.62
|
34.88 units
Standard Deviation 17.44
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 21 (n=154, 165)
|
31.83 units
Standard Deviation 19.05
|
35.14 units
Standard Deviation 17.24
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 24 (n=150, 153)
|
31.99 units
Standard Deviation 19.59
|
35.61 units
Standard Deviation 18.34
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 27 (n=142, 153)
|
31.25 units
Standard Deviation 19.01
|
35.58 units
Standard Deviation 18.42
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 30 (n=141, 148)
|
31.06 units
Standard Deviation 19.73
|
35.34 units
Standard Deviation 18.73
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 33 (n=133, 144)
|
30.71 units
Standard Deviation 19.06
|
34.83 units
Standard Deviation 17.47
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 36 (n=113, 136)
|
29.62 units
Standard Deviation 19.06
|
33.58 units
Standard Deviation 15.64
|
|
Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 39 (n=57, 67)
|
29.07 units
Standard Deviation 16.59
|
33.63 units
Standard Deviation 19.79
|
SECONDARY outcome
Timeframe: Month 3 through Extension Month 39Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total daily dose of long-acting insulin adjusted for body weight (units per kilogram \[kg\]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 33 (n=133, 144)
|
0.42 units/kg
Standard Deviation 0.25
|
0.48 units/kg
Standard Deviation 0.23
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 36 (n=113, 136)
|
0.40 units/kg
Standard Deviation 0.25
|
0.46 units/kg
Standard Deviation 0.21
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 3 (n=280, 285)
|
0.41 units/kg
Standard Deviation 0.22
|
0.48 units/kg
Standard Deviation 0.25
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 6 (n=271, 280)
|
0.41 units/kg
Standard Deviation 0.23
|
0.49 units/kg
Standard Deviation 0.25
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month9 (n=256, 269)
|
0.41 units/kg
Standard Deviation 0.23
|
0.49 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 12 (n=243, 262)
|
0.41 units/kg
Standard Deviation 0.24
|
0.49 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 15 (n=237, 255)
|
0.42 units/kg
Standard Deviation 0.25
|
0.49 units/kg
Standard Deviation 0.25
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 18 (n=234, 242)
|
0.42 units/kg
Standard Deviation 0.25
|
0.50 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 21 (n=224, 233)
|
0.42 units/kg
Standard Deviation 0.26
|
0.51 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Month 24 (n=218, 229)
|
0.43 units/kg
Standard Deviation 0.27
|
0.50 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 1 (n=171, 178)
|
0.45 units/kg
Standard Deviation 0.25
|
0.49 units/kg
Standard Deviation 0.27
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 3 (n=170, 177)
|
0.44 units/kg
Standard Deviation 0.25
|
0.49 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 6 (n=166, 179)
|
0.43 units/kg
Standard Deviation 0.24
|
0.48 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 9 (n=160, 174)
|
0.44 units/kg
Standard Deviation 0.25
|
0.49 units/kg
Standard Deviation 0.25
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 12 (n=159, 169)
|
0.44 units/kg
Standard Deviation 0.24
|
0.47 units/kg
Standard Deviation 0.22
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 15 (n=156, 164)
|
0.44 units/kg
Standard Deviation 0.25
|
0.49 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 18 (n=152, 166)
|
0.44 units/kg
Standard Deviation 0.25
|
0.48 units/kg
Standard Deviation 0.24
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 21 (n=154, 165)
|
0.44 units/kg
Standard Deviation 0.25
|
0.48 units/kg
Standard Deviation 0.23
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 24 (n=150, 153)
|
0.44 units/kg
Standard Deviation 0.26
|
0.49 units/kg
Standard Deviation 0.25
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 27 (n=142, 153)
|
0.43 units/kg
Standard Deviation 0.24
|
0.49 units/kg
Standard Deviation 0.24
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 30 (n=141, 148)
|
0.42 units/kg
Standard Deviation 0.26
|
0.49 units/kg
Standard Deviation 0.26
|
|
Total Daily Long-Acting Insulin Dose Adjusted for Body Weight
Extension Month 39 (n=57, 67)
|
0.39 units/kg
Standard Deviation 0.23
|
0.45 units/kg
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Month 3 through Extension Month 39Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total daily dose of short-acting insulin unadjusted for body weight. 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.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 3 (n=170, 178)
|
12.50 mg, units
Standard Deviation 6.88
|
25.94 mg, units
Standard Deviation 18.26
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 6 (n=166, 179)
|
13.64 mg, units
Standard Deviation 9.07
|
25.39 mg, units
Standard Deviation 17.52
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 21 (n=224, 235)
|
14.42 mg, units
Standard Deviation 8.64
|
25.45 mg, units
Standard Deviation 15.41
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 24 (n=219, 232)
|
14.61 mg, units
Standard Deviation 9.14
|
25.23 mg, units
Standard Deviation 16.57
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 3 (n=280, 285)
|
10.45 mg, units
Standard Deviation 5.71
|
25.05 mg, units
Standard Deviation 14.73
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 6 (n=271, 281)
|
11.50 mg, units
Standard Deviation 6.73
|
25.14 mg, units
Standard Deviation 14.72
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 9 (n=257, 271)
|
11.97 mg, units
Standard Deviation 6.79
|
24.90 mg, units
Standard Deviation 14.54
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 12 (n=243, 266)
|
12.69 mg, units
Standard Deviation 6.96
|
25.32 mg, units
Standard Deviation 14.35
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 15 (n=237, 255)
|
13.12 mg, units
Standard Deviation 7.65
|
25.11 mg, units
Standard Deviation 14.83
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Month 18 (n=234, 241)
|
13.60 mg, units
Standard Deviation 8.04
|
25.20 mg, units
Standard Deviation 15.15
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 1 (n=170, 179)
|
11.49 mg, units
Standard Deviation 6.35
|
25.84 mg, units
Standard Deviation 17.48
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 9 (n=160, 174)
|
14.06 mg, units
Standard Deviation 9.33
|
26.19 mg, units
Standard Deviation 18.00
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 12 (n=159, 169)
|
14.74 mg, units
Standard Deviation 10.07
|
25.49 mg, units
Standard Deviation 17.69
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 15 (n=156, 167)
|
13.93 mg, units
Standard Deviation 8.38
|
25.80 mg, units
Standard Deviation 17.62
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 18 (n=153, 167)
|
13.97 mg, units
Standard Deviation 8.58
|
26.04 mg, units
Standard Deviation 17.52
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 21 (n=154, 166)
|
14.53 mg, units
Standard Deviation 8.80
|
25.95 mg, units
Standard Deviation 17.04
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 24 (n=150, 156)
|
14.48 mg, units
Standard Deviation 8.71
|
27.26 mg, units
Standard Deviation 19.48
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 27 (n=142, 153)
|
14.82 mg, units
Standard Deviation 8.70
|
26.63 mg, units
Standard Deviation 17.82
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 30 (n=141, 149)
|
14.92 mg, units
Standard Deviation 8.93
|
27.22 mg, units
Standard Deviation 18.66
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 33 (n=133, 144)
|
15.28 mg, units
Standard Deviation 9.72
|
26.71 mg, units
Standard Deviation 18.67
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 36 (n=113, 136)
|
15.72 mg, units
Standard Deviation 8.32
|
27.04 mg, units
Standard Deviation 19.65
|
|
Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)
Extension Month 39 (n=57, 67)
|
17.92 mg, units
Standard Deviation 12.04
|
29.75 mg, units
Standard Deviation 19.68
|
SECONDARY outcome
Timeframe: Month 3 through Extension Month 39Population: FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.
Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams \[mg\] or units divided by kilograms \[kg\]). 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.
Outcome measures
| Measure |
Inhaled Insulin
n=288 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=286 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 6 (n=166, 179)
|
0.18 mg/kg, units/kg
Standard Deviation 0.10
|
0.34 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 9 (n=160, 174)
|
0.19 mg/kg, units/kg
Standard Deviation 0.11
|
0.35 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 12 (n=159, 169)
|
0.20 mg/kg, units/kg
Standard Deviation 0.13
|
0.34 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 24 (n=150, 156)
|
0.20 mg/kg, units/kg
Standard Deviation 0.11
|
0.36 mg/kg, units/kg
Standard Deviation 0.24
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 27 (n=142, 153)
|
0.20 mg/kg, units/kg
Standard Deviation 0.11
|
0.36 mg/kg, units/kg
Standard Deviation 0.23
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 30 (n=141, 149)
|
0.20 mg/kg, units/kg
Standard Deviation 0.11
|
0.37 mg/kg, units/kg
Standard Deviation 0.24
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 33 (n=133, 144)
|
0.20 mg/kg, units/kg
Standard Deviation 0.12
|
0.36 mg/kg, units/kg
Standard Deviation 0.24
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 3 (n=280, 285)
|
0.14 mg/kg, units/kg
Standard Deviation 0.07
|
0.34 mg/kg, units/kg
Standard Deviation 0.19
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 6 (n=271, 281)
|
0.15 mg/kg, units/kg
Standard Deviation 0.08
|
0.34 mg/kg, units/kg
Standard Deviation 0.19
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 9 (n=257, 271)
|
0.16 mg/kg, units/kg
Standard Deviation 0.09
|
0.34 mg/kg, units/kg
Standard Deviation 0.18
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 12 (n=243, 266)
|
0.17 mg/kg, units/kg
Standard Deviation 0.09
|
0.34 mg/kg, units/kg
Standard Deviation 0.18
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 15 (n=237, 255)
|
0.17 mg/kg, units/kg
Standard Deviation 0.10
|
0.34 mg/kg, units/kg
Standard Deviation 0.19
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 18 (n=234, 241)
|
0.18 mg/kg, units/kg
Standard Deviation 0.10
|
0.34 mg/kg, units/kg
Standard Deviation 0.19
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 21 (n=224, 235)
|
0.19 mg/kg, units/kg
Standard Deviation 0.11
|
0.34 mg/kg, units/kg
Standard Deviation 0.20
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Month 24 (n=219, 232)
|
0.19 mg/kg, units/kg
Standard Deviation 0.12
|
0.34 mg/kg, units/kg
Standard Deviation 0.21
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 1 (n=170, 179)
|
0.15 mg/kg, units/kg
Standard Deviation 0.08
|
0.35 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 3 (n=170, 178)
|
0.17 mg/kg, units/kg
Standard Deviation 0.08
|
0.35 mg/kg, units/kg
Standard Deviation 0.23
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 15 (n=156, 167)
|
0.19 mg/kg, units/kg
Standard Deviation 0.10
|
0.35 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 18 (n=153, 167)
|
0.19 mg/kg, units/kg
Standard Deviation 0.10
|
0.35 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 21 (n=154, 166)
|
0.19 mg/kg, units/kg
Standard Deviation 0.11
|
0.35 mg/kg, units/kg
Standard Deviation 0.22
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 36 (n=113, 136)
|
0.21 mg/kg, units/kg
Standard Deviation 0.11
|
0.36 mg/kg, units/kg
Standard Deviation 0.25
|
|
Total Daily Short-Acting Insulin Dose Adjusted for Body Weight
Extension Month 39 (n=57, 67)
|
0.23 mg/kg, units/kg
Standard Deviation 0.14
|
0.39 mg/kg, units/kg
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Week - 1Population: FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Baseline Dyspnea Index were not summarized as planned.
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of studyPopulation: FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Transition Dyspnea Index were not summarized as planned.
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week -4 through Month 24Population: Full Analysis Set (FAS): received at least 1 dose of study treatment. Due to early termination of the study a limited set of analyses were undertaken and lipid results were not summarized as planned.
Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0 and if indicated through Extension Follow up Month 3Population: FAS. Due to early termination of the study a limited set of analyses were undertaken and results of the Cough Questionnaire were not summarized as planned.
Subject completed cough questionnaire with reference to the past 4 weeks. Six question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (subcutaneous \[SC\] or inhaled), and productivity of cough; range 0 (no symptoms) to 4 (severe symptoms). Questionnaire was administered at Week 0 and then at subsequent visits only if cough was identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week -3 through Extension Follow-up Month 6 or End of StudyPopulation: FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and FVC results were not summarized as planned.
Forced Vital Capacity (FVC) measured in liters (L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week -3 through Extension Follow-up Month 6 or End of StudyPopulation: FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and TLC results were not summarized as planned.
Total Lung Capacity measured in liters (L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Extension Month 39Population: FAS; (n)= number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.
Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).
Outcome measures
| Measure |
Inhaled Insulin
n=284 Participants
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=283 Participants
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Insulin Antibodies
Month 21 (n=216, 228)
|
59.50 microU/mL
Interval 1.05 to 2575.0
|
3.85 microU/mL
Interval 1.05 to 932.0
|
|
Insulin Antibodies
Month 24 (n=212, 224)
|
67.00 microU/mL
Interval 1.05 to 2360.0
|
4.40 microU/mL
Interval 1.05 to 1420.0
|
|
Insulin Antibodies
Extension Month 33 (n=129, 142)
|
35.00 microU/mL
Interval 1.05 to 3980.0
|
4.30 microU/mL
Interval 1.05 to 845.0
|
|
Insulin Antibodies
Extension Month 36 (n=104, 132)
|
30.50 microU/mL
Interval 1.05 to 1477.0
|
3.65 microU/mL
Interval 1.05 to 876.0
|
|
Insulin Antibodies
Extension Month 39 (n=54, 66)
|
25.50 microU/mL
Interval 1.05 to 1750.0
|
1.58 microU/mL
Interval 1.05 to 742.0
|
|
Insulin Antibodies
Baseline (n=284, 283)
|
4.50 microU/mL
Interval 1.05 to 3514.0
|
4.10 microU/mL
Interval 1.05 to 1324.0
|
|
Insulin Antibodies
Week 3 (n=262, 260)
|
7.50 microU/mL
Interval 1.05 to 6056.0
|
3.60 microU/mL
Interval 1.05 to 828.0
|
|
Insulin Antibodies
Week 6 (n=267, 260)
|
15.00 microU/mL
Interval 1.05 to 12445.0
|
4.00 microU/mL
Interval 1.05 to 1792.0
|
|
Insulin Antibodies
Month 3 (n=271, 274)
|
31.00 microU/mL
Interval 1.05 to 4108.0
|
4.25 microU/mL
Interval 1.05 to 876.0
|
|
Insulin Antibodies
Week 18 (n=263, 271)
|
49.00 microU/mL
Interval 1.05 to 1968.0
|
4.40 microU/mL
Interval 1.05 to 1012.0
|
|
Insulin Antibodies
Month 6 (n=254, 268)
|
88.50 microU/mL
Interval 1.05 to 1420.0
|
5.10 microU/mL
Interval 1.05 to 1352.0
|
|
Insulin Antibodies
Month 9 (n=244, 262)
|
134.50 microU/mL
Interval 1.05 to 2776.0
|
4.95 microU/mL
Interval 1.05 to 1608.0
|
|
Insulin Antibodies
Month 12 (n=234, 258)
|
142.50 microU/mL
Interval 1.05 to 3156.0
|
4.90 microU/mL
Interval 1.05 to 2192.0
|
|
Insulin Antibodies
Month 15 (n=230, 250)
|
109.50 microU/mL
Interval 1.05 to 4380.0
|
4.70 microU/mL
Interval 1.05 to 1360.0
|
|
Insulin Antibodies
Month 18 (n=226, 233)
|
91.00 microU/mL
Interval 1.05 to 2390.0
|
4.40 microU/mL
Interval 1.05 to 1655.0
|
|
Insulin Antibodies
Follow-up Month 1 (n=234, 209)
|
41.50 microU/mL
Interval 1.05 to 27286.0
|
4.20 microU/mL
Interval 1.05 to 1285.0
|
|
Insulin Antibodies
Follow-up Month 3 (n=245, 226)
|
28.00 microU/mL
Interval 1.05 to 8119.0
|
4.20 microU/mL
Interval 1.05 to 382.0
|
|
Insulin Antibodies
Follow-up Month 6 (n=239, 223)
|
22.00 microU/mL
Interval 1.05 to 5280.0
|
4.40 microU/mL
Interval 1.05 to 1265.0
|
|
Insulin Antibodies
Extension Month 1 (n=164, 176)
|
37.50 microU/mL
Interval 1.05 to 3985.0
|
4.50 microU/mL
Interval 1.05 to 900.0
|
|
Insulin Antibodies
Extension Month 3 (165, 177)
|
45.00 microU/mL
Interval 1.05 to 3405.0
|
4.40 microU/mL
Interval 1.05 to 1260.0
|
|
Insulin Antibodies
Extension Month 6 (n=162, 176)
|
42.50 microU/mL
Interval 1.05 to 3145.0
|
3.55 microU/mL
Interval 1.05 to 720.0
|
|
Insulin Antibodies
Extension Month 9 (n=154, 167)
|
41.00 microU/mL
Interval 1.05 to 2465.0
|
4.70 microU/mL
Interval 1.05 to 873.0
|
|
Insulin Antibodies
Extension Month 12 (n=155, 167)
|
49.00 microU/mL
Interval 1.05 to 3280.0
|
4.30 microU/mL
Interval 1.05 to 1310.0
|
|
Insulin Antibodies
Extension Month 15 (n=149, 163)
|
43.00 microU/mL
Interval 1.05 to 3955.0
|
4.50 microU/mL
Interval 1.05 to 1330.0
|
|
Insulin Antibodies
Extension Month 18 (n=149, 160)
|
45.00 microU/mL
Interval 1.05 to 10755.0
|
3.60 microU/mL
Interval 1.05 to 1430.0
|
|
Insulin Antibodies
Extension Month 21 (n=151, 157)
|
44.00 microU/mL
Interval 1.05 to 3200.0
|
3.60 microU/mL
Interval 1.05 to 820.0
|
|
Insulin Antibodies
Extension Month 24 (n=146, 153)
|
42.50 microU/mL
Interval 1.05 to 3920.0
|
4.40 microU/mL
Interval 1.05 to 758.0
|
|
Insulin Antibodies
Extension Month 27 (n=138, 148)
|
35.00 microU/mL
Interval 1.05 to 3040.0
|
6.35 microU/mL
Interval 1.05 to 1121.0
|
|
Insulin Antibodies
Extension Month 30 (n=139, 150)
|
36.00 microU/mL
Interval 1.05 to 3730.0
|
5.25 microU/mL
Interval 1.05 to 1110.0
|
Adverse Events
Inhaled Insulin
Serious events: 50 serious events
Other events: 290 other events
Deaths: 0 deaths
Subcutaneous Insulin
Serious events: 65 serious events
Other events: 289 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Insulin
n=290 participants at risk
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=290 participants at risk
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Angina pectoris
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Arrhythmia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Coronary artery disease
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
1.4%
4/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Eye disorders
Macular degeneration
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Chest discomfort
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Chest pain
|
1.4%
4/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Cellulitis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Cystitis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gangrene
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Influenza
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Kidney infection
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Meningitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Pneumonia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Postoperative wound infection
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Sepsis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.0%
26/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Intracranial hypotension
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Sciatica
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.69%
2/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Renal and urinary disorders
Renal colic
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Reproductive system and breast disorders
Uterine disorder
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
0.34%
1/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
Other adverse events
| Measure |
Inhaled Insulin
n=290 participants at risk
Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
|
Subcutaneous Insulin
n=290 participants at risk
Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
10/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
36/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
9.7%
28/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
30/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
7.2%
21/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
20/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Asthenia
|
6.6%
19/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
7.2%
21/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Chest pain
|
6.2%
18/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
General disorders
Fatigue
|
7.6%
22/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.6%
25/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Immune system disorders
Seasonal allergy
|
5.2%
15/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.2%
15/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Bronchitis
|
8.3%
24/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.6%
25/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gastroenteritis
|
10.0%
29/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.6%
25/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Gastroenteritis viral
|
9.0%
26/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
6.2%
18/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Influenza
|
29.0%
84/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
29.3%
85/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Nasopharyngitis
|
33.1%
96/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
38.3%
111/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Pharyngitis
|
5.2%
15/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Rhinitis
|
6.9%
20/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
4.8%
14/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Sinusitis
|
17.2%
50/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
16.2%
47/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Upper respiratory tract infection
|
42.8%
124/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
36.2%
105/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Infections and infestations
Urinary tract infection
|
10.7%
31/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
11.0%
32/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
7/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.2%
15/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
2.4%
7/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
97.2%
282/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
98.3%
285/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
31/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
11.7%
34/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
24/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
10.7%
31/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.3%
24/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
18/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
10.3%
30/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.5%
16/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
4.5%
13/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Dizziness
|
6.9%
20/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
7.6%
22/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Headache
|
14.1%
41/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
15.9%
46/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Nervous system disorders
Tremor
|
14.5%
42/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
14.8%
43/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Depression
|
4.1%
12/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.6%
25/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Insomnia
|
5.5%
16/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
2.8%
8/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Psychiatric disorders
Stress
|
5.9%
17/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.2%
15/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.8%
130/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
18.3%
53/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
24/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
2.1%
6/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.2%
21/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
4.8%
14/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.1%
35/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
16.2%
47/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.1%
12/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
5.2%
15/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.6%
25/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
7.9%
23/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.7%
28/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
10.7%
31/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
|
Vascular disorders
Hypertension
|
8.3%
24/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
8.3%
24/290
Adverse events for this study are reported using MedDRA in these Basic Results, but are reported using COSTART in the Clinical Study Report and PhRMA Web Synopsis for consistency with earlier studies. Consequently, subtle differences may be observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER