A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00138671
First received: August 26, 2005
Last updated: January 25, 2010
Last verified: August 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Chronic Obstructive Pulmonary Disease |
Drug: Subcutaneous Insulin Drug: Inhaled Insulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ] [ Designated as safety issue: Yes ]
- Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco) [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Other PFTs (Besides FEV1 and DLco) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Bronchodilator Responsiveness as Determined by the Change in FEV1 [ Time Frame: Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 ] [ Designated as safety issue: Yes ]
- Insulin Dose Responsiveness for FEV1 [ Time Frame: Baseline, Week 9, Week 51 ] [ Designated as safety issue: Yes ]
- Insulin Dose Responsiveness for DLco [ Time Frame: Baseline, Week 9, Week 51 ] [ Designated as safety issue: Yes ]
- Methacholine PC20 [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [ Time Frame: 0 to 1 week to > 9 months ] [ Designated as safety issue: Yes ]
- Incidence of Severe COPD Exacerbations [ Time Frame: 0 to 1 week to > 9 months ] [ Designated as safety issue: Yes ]
- Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Weeks 6, 12, 26, 39, and 52 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Plasma Glucose [ Time Frame: Baseline, Weeks 6, 12, 26, 39, 52 ] [ Designated as safety issue: No ]
- Change From Baseline in Body Weight [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52 ] [ Designated as safety issue: No ]
- Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ] [ Designated as safety issue: No ]
- Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ] [ Designated as safety issue: No ]
- Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ] [ Designated as safety issue: No ]
- Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight) [ Time Frame: Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52 ] [ Designated as safety issue: No ]
- Lipids [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
- Hypoglycemic Event Rates [ Time Frame: 0 to1 month to > 11 months ] [ Designated as safety issue: No ]
- Severe Hypoglcyemic Event Rates [ Time Frame: 0 to 1 month to > 11 months ] [ Designated as safety issue: No ]
| Enrollment: | 105 |
| Study Start Date: | January 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Subcutaneous Insulin |
Drug: Subcutaneous Insulin
Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
|
| Experimental: Inhaled Insulin |
Drug: Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
|
Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
Eligibility| Ages Eligible for Study: | 30 Years to 77 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
- Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough.
Exclusion Criteria:
- Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138671
Show 88 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138671
Show 88 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00138671 History of Changes |
| Other Study ID Numbers: | A2171030 |
| Study First Received: | August 26, 2005 |
| Results First Received: | September 2, 2009 |
| Last Updated: | January 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Respiratory Tract Diseases Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016