Trial Outcomes & Findings for A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera. (NCT NCT00437489)
NCT ID: NCT00437489
Last Updated: 2009-05-11
Results Overview
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
TERMINATED
PHASE4
49 participants
From baseline to week 16
2009-05-11
Participant Flow
Five centers in the Philippines, 2 centers in Singapore, 1 center in Hong Kong, and 1 center in Pakistan enrolled subjects.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study before it had recruited targeted number of subjects and followed them for the per protocol specified period.
Participant milestones
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
23
|
22
|
Reasons for withdrawal
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Overall Study
Study terminated by sponsor
|
23
|
21
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
Baseline characteristics by cohort
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
n=25 Participants
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
n=24 Participants
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
18 - 44 years
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Age, Customized
45 - 64 years
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 16Population: Full analysis set (FAS) population - descriptive statistics were produced using last observation carried forward (LOCF) for Week 16, therefore all subjects are included in the Week 16 data.
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
Outcome measures
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
n=25 Participants
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
n=24 Participants
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Change in HbA1c From Baseline
|
-1.9 Percent
Standard Deviation 1.56
|
-2.0 Percent
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: From baseline to week 16Population: FAS - descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.
Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.
Outcome measures
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
n=25 Participants
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
n=24 Participants
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Fasting plasma glucose
|
-1.8 mmol/l
Standard Deviation 2.36
|
-2.9 mmol/l
Standard Deviation 5.62
|
|
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Overall absolute blood glucose
|
-2.5 mmol/l
Standard Deviation 3.62
|
-4.3 mmol/l
Standard Deviation 4.20
|
|
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Pre-meal blood glucose
|
-1.7 mmol/l
Standard Deviation 3.58
|
-3.3 mmol/l
Standard Deviation 4.05
|
|
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Post-meal blood glucose
|
-4.1 mmol/l
Standard Deviation 3.78
|
-5.5 mmol/l
Standard Deviation 4.28
|
|
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)
Change from pre-meal to post-meal blood glucose
|
-2.5 mmol/l
Standard Deviation 2.14
|
-2.1 mmol/l
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: week 16Population: FAS Population - Descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.
Cumulative Number Subjects Who Experienced Hypoglycemia \& Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose \<3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.
Outcome measures
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
n=25 Participants
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
n=24 Participants
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia
Hypoglycemia
|
12 participants
|
5 participants
|
|
Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia
Nocturnal hypoglycemia
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: up to week 4 or 16Population: FAS Population
Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).
Outcome measures
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
n=25 Participants
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
n=24 Participants
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Hypoglycemia Event Rate Per Month
up to week 4 (GrpA:n=8, GrpB:n=4)
|
3.3 event rate per month
Standard Deviation 3.3
|
8.3 event rate per month
Standard Deviation 9.1
|
|
Hypoglycemia Event Rate Per Month
up to week 16 (GrpA:n=12, GrpB:n=5)
|
2.4 event rate per month
Standard Deviation 2.4
|
2.5 event rate per month
Standard Deviation 1.3
|
Adverse Events
Exubera Dose of 1mg Three Times Daily (TID)
Exubera Dose (mg) as Per Weight Based Formula TID
Serious adverse events
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Vascular disorders
Blood pressure inadequately controlled
|
4.0%
1/25
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Pelvic Instability at the Lumbar Spine
|
4.0%
1/25
|
0.00%
0/24
|
|
Nervous system disorders
Diabetic Neuropathy
|
4.0%
1/25
|
0.00%
0/24
|
Other adverse events
| Measure |
Exubera Dose of 1mg Three Times Daily (TID)
Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
|
Exubera Dose (mg) as Per Weight Based Formula TID
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
|
|---|---|---|
|
Eye disorders
Eye disorders
|
8.0%
2/25
|
4.2%
1/24
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
16.0%
4/25
|
8.3%
2/24
|
|
General disorders
General disorders and administration site conditions
|
20.0%
5/25
|
25.0%
6/24
|
|
Infections and infestations
Infections and infestations
|
12.0%
3/25
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Metabolism and nutrition discorders
|
48.0%
12/25
|
20.8%
5/24
|
|
Nervous system disorders
Nervous system disorders
|
40.0%
10/25
|
25.0%
6/24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
12.0%
3/25
|
12.5%
3/24
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
16.0%
4/25
|
12.5%
3/24
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/25
|
8.3%
2/24
|
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 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER