Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00527397
First received: September 7, 2007
Last updated: October 5, 2009
Last verified: July 2009
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 |
Drug: CP-464,005 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Uncontrolled Long-Term Safety Study Of CP-464,005 (Inhaled Insulin) In Japanese Patients With Type 1 Or Type 2 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Self-Monitoring Blood Glucose Levels: Change From Baseline [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Daily Inhaled Insulin Dose [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
- The Values of Hemoglobin A1c:Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, Week 26, End of treatment ] [ Designated as safety issue: No ]
- The Value of Fasting Plasma Glucose:Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, Week 26 ] [ Designated as safety issue: No ]
- The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin [ Time Frame: 0 month to 12 months ] [ Designated as safety issue: No ]
- The Values of Forced Expiratory Volume at 1 Second:Change From Baseline [ Time Frame: Beseline, Week 1, Week 2, Week 6, Week 12, Week 26 ] [ Designated as safety issue: Yes ]
- The Values of Forced Vital Capacity:Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment ] [ Designated as safety issue: Yes ]
- The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment ] [ Designated as safety issue: Yes ]
- Insulin Antibody Levels : Change From Baseline [ Time Frame: Baseline, Week 6, Week 12, End of treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | August 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B
Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin
|
Drug: CP-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.
Other Name: Exubera
|
|
Experimental: C
Type 2 DM who has already treated by Insulin
|
Drug: CP-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.
Other Name: Exubera
|
|
Experimental: A
Type 1 DM
|
Drug: CP-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.
Other Name: Exubera
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527397
Locations
| Japan | |
| Pfizer Investigational Site | |
| Nagoya-shi, Aichi, Japan | |
| Pfizer Investigational Site | |
| Yokohama-shi, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Tenri-shi, Nara, Japan | |
| Pfizer Investigational Site | |
| Takatsuki-shi, Oosaka, Japan | |
| Pfizer Investigational Site | |
| Bunkyo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Meguro-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Toyama-shi, Toyama, Japan | |
| Pfizer Investigational Site | |
| Kyoto, Japan | |
| Pfizer Investigational Site | |
| Osaka, Japan | |
| Pfizer Investigational Site | |
| Tokyo, Japan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00527397 History of Changes |
| Other Study ID Numbers: | A2171105 |
| Study First Received: | September 7, 2007 |
| Results First Received: | July 15, 2009 |
| Last Updated: | October 5, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Pfizer:
|
Diabetes Mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013