Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus
Brief summary
Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)
Detailed description
Pfizer announced in October 2007 that it would stop marketing CP-464,005. At that time recruitment for study, A2171105 was placed on hold. Nektar, the company from which Pfizer licensed CP-464,005, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171105 was terminated on April 10, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
Interventions
DRUGCP-464,005
Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.
Exclusion criteria
* Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well) * Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 \< 70% of predicted) ) at Week -4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Monitoring Blood Glucose Levels: Change From Baseline | One year | Self-monitoring blood glucose levels obtained at each observation point minus that at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Values of Hemoglobin A1c:Change From Baseline | Baseline, Week 6, Week 12, Week 26, End of treatment | 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. |
| The Value of Fasting Plasma Glucose:Change From Baseline | Baseline, Week 6, Week 12, Week 26 | 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. |
| The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | 0 month to 12 months | 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 |
| Daily Inhaled Insulin Dose | Up to 26 weeks | 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. |
| The Values of Forced Vital Capacity:Change From Baseline | Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment | 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. |
| The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline | Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment | 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. |
| Insulin Antibody Levels : Change From Baseline | Baseline, Week 6, Week 12, End of treatment | 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. |
| The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | Beseline, Week 1, Week 2, Week 6, Week 12, Week 26 | 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. |
Countries
Japan
Participant flow
Recruitment details
10 centers in Japan.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Study terminated by sponsor | 13 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | All Subjects With Type 1 or Type 2 Diabetes Mellitus |
|---|---|
| Age Continuous | 55.2 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / — |
| serious Total, serious adverse events | 3 / — |
Outcome results
Primary
Self-Monitoring Blood Glucose Levels: Change From Baseline
Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.
Time frame: One year
Population: This endopoint was not analyzed because of small numbers of subjects due to early termination
Secondary
Daily Inhaled Insulin Dose
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.
Time frame: Up to 26 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 1 (n=6, 12, 6) | 9.8 milligram | Standard Deviation 4.3 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Day 3 (n=6, 12, 6) | 9.8 milligram | Standard Deviation 4.6 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 12 (n=4, 7, 5) | 5.5 milligram | Standard Deviation 1.7 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 2 (n=6, 11, 6) | 9.3 milligram | Standard Deviation 3.9 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Day 2 (n=6, 12, 6) | 9.7 milligram | Standard Deviation 4 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 8 (n=5, 8, 6) | 8.0 milligram | Standard Deviation 4.4 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 4 (n=5, 11, 6) | 8.4 milligram | Standard Deviation 5 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 20 (n=3, 5, 3) | 5.0 milligram | Standard Deviation 2 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 6 (n=5, 9, 6) | 8.8 milligram | Standard Deviation 4.3 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Day 4 (n=6, 12, 6) | 10.0 milligram | Standard Deviation 4.1 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | End of treatment (n=6, 12, 6) | 7.7 milligram | Standard Deviation 4 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Day 1 (n=6, 12, 6) | 8.8 milligram | Standard Deviation 3.4 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Day 5 (n=6, 12, 6) | 7.7 milligram | Standard Deviation 3.7 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 26 (n=3, 5, 3) | 6.0 milligram | Standard Deviation 2.6 |
| Type 1 Diabetes Mellitus | Daily Inhaled Insulin Dose | Week 16 (n=3, 6, 3) | 6.0 milligram | Standard Deviation 2.6 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 16 (n=3, 6, 3) | 11.5 milligram | Standard Deviation 7.7 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Day 1 (n=6, 12, 6) | 7.2 milligram | Standard Deviation 2.5 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Day 2 (n=6, 12, 6) | 7.6 milligram | Standard Deviation 3.5 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Day 3 (n=6, 12, 6) | 7.8 milligram | Standard Deviation 3.8 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Day 4 (n=6, 12, 6) | 7.8 milligram | Standard Deviation 3.8 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Day 5 (n=6, 12, 6) | 7.8 milligram | Standard Deviation 3.8 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 1 (n=6, 12, 6) | 8.5 milligram | Standard Deviation 5 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 2 (n=6, 11, 6) | 8.9 milligram | Standard Deviation 5.6 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 4 (n=5, 11, 6) | 8.4 milligram | Standard Deviation 5.1 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 6 (n=5, 9, 6) | 8.1 milligram | Standard Deviation 5.6 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 8 (n=5, 8, 6) | 9.0 milligram | Standard Deviation 6.6 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 12 (n=4, 7, 5) | 9.9 milligram | Standard Deviation 6.6 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 20 (n=3, 5, 3) | 12.4 milligram | Standard Deviation 8.2 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | Week 26 (n=3, 5, 3) | 12.4 milligram | Standard Deviation 8.2 |
| Type 2 Diabetes Mellitus Using Insulin | Daily Inhaled Insulin Dose | End of treatment (n=6, 12, 6) | 9.1 milligram | Standard Deviation 6.7 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 1 (n=6, 12, 6) | 5.8 milligram | Standard Deviation 2.5 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 26 (n=3, 5, 3) | 6.3 milligram | Standard Deviation 1.5 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 12 (n=4, 7, 5) | 5.4 milligram | Standard Deviation 3 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Day 5 (n=6, 12, 6) | 5.5 milligram | Standard Deviation 2.6 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Day 4 (n=6, 12, 6) | 5.5 milligram | Standard Deviation 2.3 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 16 (n=3, 6, 3) | 5.0 milligram | Standard Deviation 2 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Day 3 (n=6, 12, 6) | 5.8 milligram | Standard Deviation 2.5 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Day 1 (n=6, 12, 6) | 5.5 milligram | Standard Deviation 2.3 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 20 (n=3, 5, 3) | 6.3 milligram | Standard Deviation 1.5 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 4 (n=5, 11, 6) | 5.2 milligram | Standard Deviation 2.6 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Day 2 (n=6, 12, 6) | 5.5 milligram | Standard Deviation 2.3 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 6 (n=5, 9, 6) | 5.8 milligram | Standard Deviation 2.9 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 2 (n=6, 11, 6) | 5.5 milligram | Standard Deviation 2.9 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | End of treatment (n=6, 12, 6) | 6.8 milligram | Standard Deviation 2.6 |
| Type 2 Diabetes Mellitus Not Using Insulin | Daily Inhaled Insulin Dose | Week 8 (n=5, 8, 6) | 5.7 milligram | Standard Deviation 2.7 |
Secondary
Insulin Antibody Levels : Change From Baseline
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.
Time frame: Baseline, Week 6, Week 12, End of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Diabetes Mellitus | Insulin Antibody Levels : Change From Baseline | Week 12 (n=4, 6, 3) | 9.78 microunit/milliliter | Standard Deviation 7.02 |
| Type 1 Diabetes Mellitus | Insulin Antibody Levels : Change From Baseline | Week 6 (n=5, 10, 6) | 1.68 microunit/milliliter | Standard Deviation 5.71 |
| Type 1 Diabetes Mellitus | Insulin Antibody Levels : Change From Baseline | End of treatment (n=6, 12, 6) | 10.52 microunit/milliliter | Standard Deviation 11.49 |
| Type 2 Diabetes Mellitus Using Insulin | Insulin Antibody Levels : Change From Baseline | Week 12 (n=4, 6, 3) | 131.73 microunit/milliliter | Standard Deviation 154.02 |
| Type 2 Diabetes Mellitus Using Insulin | Insulin Antibody Levels : Change From Baseline | Week 6 (n=5, 10, 6) | 3630.63 microunit/milliliter | Standard Deviation 11026.91 |
| Type 2 Diabetes Mellitus Using Insulin | Insulin Antibody Levels : Change From Baseline | End of treatment (n=6, 12, 6) | 3220.95 microunit/milliliter | Standard Deviation 10025.38 |
| Type 2 Diabetes Mellitus Not Using Insulin | Insulin Antibody Levels : Change From Baseline | Week 6 (n=5, 10, 6) | -0.42 microunit/milliliter | Standard Deviation 5.4 |
| Type 2 Diabetes Mellitus Not Using Insulin | Insulin Antibody Levels : Change From Baseline | End of treatment (n=6, 12, 6) | 11.42 microunit/milliliter | Standard Deviation 9.04 |
| Type 2 Diabetes Mellitus Not Using Insulin | Insulin Antibody Levels : Change From Baseline | Week 12 (n=4, 6, 3) | 11.00 microunit/milliliter | Standard Deviation 14.29 |
Secondary
The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin
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
Time frame: 0 month to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 1 Diabetes Mellitus | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | >3 to 6 months (n=3, 6, 4) | 0.1 events / subject-month |
| Type 1 Diabetes Mellitus | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | 0 to 3 months (n=6, 12, 6) | 3.5 events / subject-month |
| Type 1 Diabetes Mellitus | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | overall (n=6, 12, 6) | 1.9 events / subject-month |
| Type 2 Diabetes Mellitus Using Insulin | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | >3 to 6 months (n=3, 6, 4) | 0.2 events / subject-month |
| Type 2 Diabetes Mellitus Using Insulin | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | 0 to 3 months (n=6, 12, 6) | 3.2 events / subject-month |
| Type 2 Diabetes Mellitus Using Insulin | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | overall (n=6, 12, 6) | 1.9 events / subject-month |
| Type 2 Diabetes Mellitus Not Using Insulin | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | 0 to 3 months (n=6, 12, 6) | 0.1 events / subject-month |
| Type 2 Diabetes Mellitus Not Using Insulin | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | overall (n=6, 12, 6) | 0.2 events / subject-month |
| Type 2 Diabetes Mellitus Not Using Insulin | The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin | >3 to 6 months (n=3, 6, 4) | 0.3 events / subject-month |
Secondary
The Value of Fasting Plasma Glucose:Change From Baseline
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.
Time frame: Baseline, Week 6, Week 12, Week 26
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Diabetes Mellitus | The Value of Fasting Plasma Glucose:Change From Baseline | Week 12 (n=3, 6, 3) | 27.7 milligram/millilitre | Standard Deviation 27.1 |
| Type 1 Diabetes Mellitus | The Value of Fasting Plasma Glucose:Change From Baseline | Week 6 (n=4, 10, 6) | 50.3 milligram/millilitre | Standard Deviation 31.3 |
| Type 1 Diabetes Mellitus | The Value of Fasting Plasma Glucose:Change From Baseline | End of treatment (n=4, 12, 6) | 87.3 milligram/millilitre | Standard Deviation 83 |
| Type 2 Diabetes Mellitus Using Insulin | The Value of Fasting Plasma Glucose:Change From Baseline | Week 12 (n=3, 6, 3) | 11.3 milligram/millilitre | Standard Deviation 47.9 |
| Type 2 Diabetes Mellitus Using Insulin | The Value of Fasting Plasma Glucose:Change From Baseline | Week 6 (n=4, 10, 6) | -1.6 milligram/millilitre | Standard Deviation 96.4 |
| Type 2 Diabetes Mellitus Using Insulin | The Value of Fasting Plasma Glucose:Change From Baseline | End of treatment (n=4, 12, 6) | 18.3 milligram/millilitre | Standard Deviation 76.9 |
| Type 2 Diabetes Mellitus Not Using Insulin | The Value of Fasting Plasma Glucose:Change From Baseline | Week 6 (n=4, 10, 6) | -3.0 milligram/millilitre | Standard Deviation 39 |
| Type 2 Diabetes Mellitus Not Using Insulin | The Value of Fasting Plasma Glucose:Change From Baseline | End of treatment (n=4, 12, 6) | -8.8 milligram/millilitre | Standard Deviation 47.9 |
| Type 2 Diabetes Mellitus Not Using Insulin | The Value of Fasting Plasma Glucose:Change From Baseline | Week 12 (n=3, 6, 3) | -5.0 milligram/millilitre | Standard Deviation 16.5 |
Secondary
The Values of Forced Expiratory Volume at 1 Second:Change From Baseline
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.
Time frame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Diabetes Mellitus | The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | Week 1 (n=23) | -0.055 liter | Standard Deviation 0.162 |
| Type 1 Diabetes Mellitus | The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | Week 2 (n=22) | -0.070 liter | Standard Deviation 0.184 |
| Type 1 Diabetes Mellitus | The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | Week 6 (n=21) | -0.065 liter | Standard Deviation 0.126 |
| Type 1 Diabetes Mellitus | The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | Week 12 (n=13) | 0.012 liter | Standard Deviation 0.137 |
| Type 1 Diabetes Mellitus | The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | Week 26 (n=4) | -0.030 liter | Standard Deviation 0.086 |
| Type 1 Diabetes Mellitus | The Values of Forced Expiratory Volume at 1 Second:Change From Baseline | End of treatment (n=24) | -0.034 liter | Standard Deviation 0.147 |
Secondary
The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline
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.
Time frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Type 1 Diabetes Mellitus | 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 |
| Type 1 Diabetes Mellitus | 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 |
| Type 1 Diabetes Mellitus | 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 |
| Type 1 Diabetes Mellitus | 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 |
| Type 1 Diabetes Mellitus | 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
The Values of Forced Vital Capacity:Change From Baseline
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.
Time frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Diabetes Mellitus | The Values of Forced Vital Capacity:Change From Baseline | Week 1 (n=23) | -0.053 liter | Standard Deviation 0.208 |
| Type 1 Diabetes Mellitus | The Values of Forced Vital Capacity:Change From Baseline | Week 2 (n=22) | 0.000 liter | Standard Deviation 0.135 |
| Type 1 Diabetes Mellitus | The Values of Forced Vital Capacity:Change From Baseline | Week 6 (n=21) | -0.003 liter | Standard Deviation 0.176 |
| Type 1 Diabetes Mellitus | The Values of Forced Vital Capacity:Change From Baseline | Week 12 (n=13) | 0.065 liter | Standard Deviation 0.204 |
| Type 1 Diabetes Mellitus | The Values of Forced Vital Capacity:Change From Baseline | Week 26 (n=4) | -0.105 liter | Standard Deviation 0.074 |
| Type 1 Diabetes Mellitus | The Values of Forced Vital Capacity:Change From Baseline | End of treatment (n=24) | -0.001 liter | Standard Deviation 0.169 |
Secondary
The Values of Hemoglobin A1c:Change From Baseline
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.
Time frame: Baseline, Week 6, Week 12, Week 26, End of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Type 1 Diabetes Mellitus | The Values of Hemoglobin A1c:Change From Baseline | End of treatment (n=6, 12, 6) | -0.22 percent | Standard Deviation 0.9 |
| Type 1 Diabetes Mellitus | The Values of Hemoglobin A1c:Change From Baseline | Week 12 (n=4, 6, 3) | -0.35 percent | Standard Deviation 0.76 |
| Type 1 Diabetes Mellitus | The Values of Hemoglobin A1c:Change From Baseline | Week 6 (n=5, 10, 6) | -0.42 percent | Standard Deviation 0.53 |
| Type 2 Diabetes Mellitus Using Insulin | The Values of Hemoglobin A1c:Change From Baseline | End of treatment (n=6, 12, 6) | 0.01 percent | Standard Deviation 0.78 |
| Type 2 Diabetes Mellitus Using Insulin | The Values of Hemoglobin A1c:Change From Baseline | Week 6 (n=5, 10, 6) | -0.39 percent | Standard Deviation 0.55 |
| Type 2 Diabetes Mellitus Using Insulin | The Values of Hemoglobin A1c:Change From Baseline | Week 12 (n=4, 6, 3) | -0.48 percent | Standard Deviation 0.72 |
| Type 2 Diabetes Mellitus Not Using Insulin | The Values of Hemoglobin A1c:Change From Baseline | End of treatment (n=6, 12, 6) | -0.48 percent | Standard Deviation 1.2 |
| Type 2 Diabetes Mellitus Not Using Insulin | The Values of Hemoglobin A1c:Change From Baseline | Week 12 (n=4, 6, 3) | -0.93 percent | Standard Deviation 0.38 |
| Type 2 Diabetes Mellitus Not Using Insulin | The Values of Hemoglobin A1c:Change From Baseline | Week 6 (n=5, 10, 6) | -0.72 percent | Standard Deviation 1.09 |