Trial Outcomes & Findings for Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes (NCT NCT00527397)
NCT ID: NCT00527397
Last Updated: 2009-10-15
Results Overview
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
TERMINATED
PHASE3
24 participants
One year
2009-10-15
Participant Flow
10 centers in Japan.
As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (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.
Participant milestones
| Measure |
All Subjects With Type 1 or Type 2 Diabetes Mellitus
All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
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|---|---|
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Overall Study
STARTED
|
24
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
|
24
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Reasons for withdrawal
| Measure |
All Subjects With Type 1 or Type 2 Diabetes Mellitus
All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
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|---|---|
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Overall Study
Adverse Event
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3
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Overall Study
Lack of Efficacy
|
1
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Overall Study
Protocol Violation
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1
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Overall Study
Withdrawal by Subject
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6
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Overall Study
Study terminated by sponsor
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13
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Baseline Characteristics
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
Baseline characteristics by cohort
| Measure |
All Subjects With Type 1 or Type 2 Diabetes Mellitus
n=24 Participants
All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
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|---|---|
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Age Continuous
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55.2 years
STANDARD_DEVIATION 15.0 • n=5 Participants
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: This endopoint was not analyzed because of small numbers of subjects due to early termination
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.
The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
n=12 Participants
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
n=6 Participants
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=6 Participants
subjects with type 1 diabetes mellitus
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|---|---|---|---|
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Daily Inhaled Insulin Dose
Day 1 (n=6, 12, 6)
|
7.2 milligram
Standard Deviation 2.5
|
5.5 milligram
Standard Deviation 2.3
|
8.8 milligram
Standard Deviation 3.4
|
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Daily Inhaled Insulin Dose
Day 2 (n=6, 12, 6)
|
7.6 milligram
Standard Deviation 3.5
|
5.5 milligram
Standard Deviation 2.3
|
9.7 milligram
Standard Deviation 4.0
|
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Daily Inhaled Insulin Dose
Day 3 (n=6, 12, 6)
|
7.8 milligram
Standard Deviation 3.8
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5.8 milligram
Standard Deviation 2.5
|
9.8 milligram
Standard Deviation 4.6
|
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Daily Inhaled Insulin Dose
Day 4 (n=6, 12, 6)
|
7.8 milligram
Standard Deviation 3.8
|
5.5 milligram
Standard Deviation 2.3
|
10.0 milligram
Standard Deviation 4.1
|
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Daily Inhaled Insulin Dose
Day 5 (n=6, 12, 6)
|
7.8 milligram
Standard Deviation 3.8
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5.5 milligram
Standard Deviation 2.6
|
7.7 milligram
Standard Deviation 3.7
|
|
Daily Inhaled Insulin Dose
Week 1 (n=6, 12, 6)
|
8.5 milligram
Standard Deviation 5.0
|
5.8 milligram
Standard Deviation 2.5
|
9.8 milligram
Standard Deviation 4.3
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Daily Inhaled Insulin Dose
Week 2 (n=6, 11, 6)
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8.9 milligram
Standard Deviation 5.6
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5.5 milligram
Standard Deviation 2.9
|
9.3 milligram
Standard Deviation 3.9
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Daily Inhaled Insulin Dose
Week 4 (n=5, 11, 6)
|
8.4 milligram
Standard Deviation 5.1
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5.2 milligram
Standard Deviation 2.6
|
8.4 milligram
Standard Deviation 5.0
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Daily Inhaled Insulin Dose
Week 6 (n=5, 9, 6)
|
8.1 milligram
Standard Deviation 5.6
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5.8 milligram
Standard Deviation 2.9
|
8.8 milligram
Standard Deviation 4.3
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Daily Inhaled Insulin Dose
Week 8 (n=5, 8, 6)
|
9.0 milligram
Standard Deviation 6.6
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5.7 milligram
Standard Deviation 2.7
|
8.0 milligram
Standard Deviation 4.4
|
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Daily Inhaled Insulin Dose
Week 12 (n=4, 7, 5)
|
9.9 milligram
Standard Deviation 6.6
|
5.4 milligram
Standard Deviation 3.0
|
5.5 milligram
Standard Deviation 1.7
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Daily Inhaled Insulin Dose
Week 16 (n=3, 6, 3)
|
11.5 milligram
Standard Deviation 7.7
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5.0 milligram
Standard Deviation 2.0
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6.0 milligram
Standard Deviation 2.6
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Daily Inhaled Insulin Dose
Week 20 (n=3, 5, 3)
|
12.4 milligram
Standard Deviation 8.2
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6.3 milligram
Standard Deviation 1.5
|
5.0 milligram
Standard Deviation 2.0
|
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Daily Inhaled Insulin Dose
Week 26 (n=3, 5, 3)
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12.4 milligram
Standard Deviation 8.2
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6.3 milligram
Standard Deviation 1.5
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6.0 milligram
Standard Deviation 2.6
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Daily Inhaled Insulin Dose
End of treatment (n=6, 12, 6)
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9.1 milligram
Standard Deviation 6.7
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6.8 milligram
Standard Deviation 2.6
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7.7 milligram
Standard Deviation 4.0
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12, Week 26, End of treatmentPopulation: Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.
Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
n=12 Participants
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
n=6 Participants
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=6 Participants
subjects with type 1 diabetes mellitus
|
|---|---|---|---|
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The Values of Hemoglobin A1c:Change From Baseline
Week 6 (n=5, 10, 6)
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-0.39 percent
Standard Deviation 0.55
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-0.72 percent
Standard Deviation 1.09
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-0.42 percent
Standard Deviation 0.53
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The Values of Hemoglobin A1c:Change From Baseline
Week 12 (n=4, 6, 3)
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-0.48 percent
Standard Deviation 0.72
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-0.93 percent
Standard Deviation 0.38
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-0.35 percent
Standard Deviation 0.76
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The Values of Hemoglobin A1c:Change From Baseline
End of treatment (n=6, 12, 6)
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0.01 percent
Standard Deviation 0.78
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-0.48 percent
Standard Deviation 1.20
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-0.22 percent
Standard Deviation 0.90
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SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12, Week 26Population: Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.
Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
n=12 Participants
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
n=6 Participants
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=6 Participants
subjects with type 1 diabetes mellitus
|
|---|---|---|---|
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The Value of Fasting Plasma Glucose:Change From Baseline
Week 6 (n=4, 10, 6)
|
-1.6 milligram/millilitre
Standard Deviation 96.4
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-3.0 milligram/millilitre
Standard Deviation 39.0
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50.3 milligram/millilitre
Standard Deviation 31.3
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The Value of Fasting Plasma Glucose:Change From Baseline
Week 12 (n=3, 6, 3)
|
11.3 milligram/millilitre
Standard Deviation 47.9
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-5.0 milligram/millilitre
Standard Deviation 16.5
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27.7 milligram/millilitre
Standard Deviation 27.1
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The Value of Fasting Plasma Glucose:Change From Baseline
End of treatment (n=4, 12, 6)
|
18.3 milligram/millilitre
Standard Deviation 76.9
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-8.8 milligram/millilitre
Standard Deviation 47.9
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87.3 milligram/millilitre
Standard Deviation 83.0
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SECONDARY outcome
Timeframe: 0 month to 12 monthsPopulation: Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.
Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
n=12 Participants
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
n=6 Participants
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=6 Participants
subjects with type 1 diabetes mellitus
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|---|---|---|---|
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The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
0 to 3 months (n=6, 12, 6)
|
3.2 events / subject-month
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0.1 events / subject-month
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3.5 events / subject-month
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The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
>3 to 6 months (n=3, 6, 4)
|
0.2 events / subject-month
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0.3 events / subject-month
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0.1 events / subject-month
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The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
overall (n=6, 12, 6)
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1.9 events / subject-month
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0.2 events / subject-month
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1.9 events / subject-month
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SECONDARY outcome
Timeframe: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26Population: Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.
Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=24 Participants
subjects with type 1 diabetes mellitus
|
|---|---|---|---|
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The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Week 1 (n=23)
|
—
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—
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-0.055 liter
Standard Deviation 0.162
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|
The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Week 2 (n=22)
|
—
|
—
|
-0.070 liter
Standard Deviation 0.184
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The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Week 6 (n=21)
|
—
|
—
|
-0.065 liter
Standard Deviation 0.126
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The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Week 12 (n=13)
|
—
|
—
|
0.012 liter
Standard Deviation 0.137
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The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
Week 26 (n=4)
|
—
|
—
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-0.030 liter
Standard Deviation 0.086
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The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
End of treatment (n=24)
|
—
|
—
|
-0.034 liter
Standard Deviation 0.147
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SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatmentPopulation: Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.
pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=24 Participants
subjects with type 1 diabetes mellitus
|
|---|---|---|---|
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The Values of Forced Vital Capacity:Change From Baseline
Week 1 (n=23)
|
—
|
—
|
-0.053 liter
Standard Deviation 0.208
|
|
The Values of Forced Vital Capacity:Change From Baseline
Week 2 (n=22)
|
—
|
—
|
0.000 liter
Standard Deviation 0.135
|
|
The Values of Forced Vital Capacity:Change From Baseline
Week 6 (n=21)
|
—
|
—
|
-0.003 liter
Standard Deviation 0.176
|
|
The Values of Forced Vital Capacity:Change From Baseline
Week 12 (n=13)
|
—
|
—
|
0.065 liter
Standard Deviation 0.204
|
|
The Values of Forced Vital Capacity:Change From Baseline
Week 26 (n=4)
|
—
|
—
|
-0.105 liter
Standard Deviation 0.074
|
|
The Values of Forced Vital Capacity:Change From Baseline
End of treatment (n=24)
|
—
|
—
|
-0.001 liter
Standard Deviation 0.169
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatmentPopulation: Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.
Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=24 Participants
subjects with type 1 diabetes mellitus
|
|---|---|---|---|
|
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Week 1 (n=23)
|
—
|
—
|
-0.003 liter/liter
Standard Deviation 0.033
|
|
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Week 2 (n=22)
|
—
|
—
|
-0.023 liter/liter
Standard Deviation 0.038
|
|
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Week 6 (n=21)
|
—
|
—
|
-0.022 liter/liter
Standard Deviation 0.034
|
|
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Week 12 (n=13)
|
—
|
—
|
-0.012 liter/liter
Standard Deviation 0.029
|
|
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
Week 26 (n=4)
|
—
|
—
|
0.013 liter/liter
Standard Deviation 0.013
|
|
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
End of treatment (n=24)
|
—
|
—
|
-0.012 liter/liter
Standard Deviation 0.043
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12, End of treatmentPopulation: Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.
Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.
Outcome measures
| Measure |
Type 2 Diabetes Mellitus Using Insulin
n=12 Participants
subjects with type 2 diabetes mellitus who had already treated by Insulin
|
Type 2 Diabetes Mellitus Not Using Insulin
n=6 Participants
subjects with type 2 diabetes mellitus who had not yet treated by Insulin
|
Type 1 Diabetes Mellitus
n=6 Participants
subjects with type 1 diabetes mellitus
|
|---|---|---|---|
|
Insulin Antibody Levels : Change From Baseline
Week 6 (n=5, 10, 6)
|
3630.63 microunit/milliliter
Standard Deviation 11026.91
|
-0.42 microunit/milliliter
Standard Deviation 5.40
|
1.68 microunit/milliliter
Standard Deviation 5.71
|
|
Insulin Antibody Levels : Change From Baseline
Week 12 (n=4, 6, 3)
|
131.73 microunit/milliliter
Standard Deviation 154.02
|
11.00 microunit/milliliter
Standard Deviation 14.29
|
9.78 microunit/milliliter
Standard Deviation 7.02
|
|
Insulin Antibody Levels : Change From Baseline
End of treatment (n=6, 12, 6)
|
3220.95 microunit/milliliter
Standard Deviation 10025.38
|
11.42 microunit/milliliter
Standard Deviation 9.04
|
10.52 microunit/milliliter
Standard Deviation 11.49
|
Adverse Events
All Subjects With Type 1 or Type 2 Diabetes Mellitus
Serious adverse events
| Measure |
All Subjects With Type 1 or Type 2 Diabetes Mellitus
all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
|
|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
4.2%
1/24
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.2%
1/24
|
Other adverse events
| Measure |
All Subjects With Type 1 or Type 2 Diabetes Mellitus
all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24
|
|
General disorders
Hunger
|
8.3%
2/24
|
|
Infections and infestations
Nasopharyngitis
|
29.2%
7/24
|
|
Infections and infestations
Tinea pedis
|
8.3%
2/24
|
|
Injury, poisoning and procedural complications
Device malfunction
|
16.7%
4/24
|
|
Investigations
Urine ketone body present
|
8.3%
2/24
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
66.7%
16/24
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
4/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
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 months 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