Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Drug: CP-464,005

• Registration Number: NCT00527397
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-07
• Results First Submitted: 2009-07-15
• Results First Submitted QC: 2009-09-01
• Results First Posted: 2009-10-05
• Last Update Submitted: 2009-10-05
• Last Update Posted: 2009-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	CP-464,005	Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
C	CP-464,005	Type 2 DM who has already treated by Insulin
A	CP-464,005	Type 1 DM

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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.
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Tokyo, Japan