A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

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”

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Subcutaneous Insulin
• Experimental: Inhaled Insulin

Primary 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
    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
    Safety Issue?: Yes

Secondary Measures

• Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)
  • Time Frame: Duration of the study
    Safety Issue?: No
• Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)
  • Time Frame: Duration of the study
    Safety Issue?: No
• Other PFTs (Besides FEV1 and DLco)
  • Time Frame: Duration of the study
    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
    Safety Issue?: Yes
• Insulin Dose Responsiveness for FEV1
  • Time Frame: Baseline, Week 9, Week 51
    Safety Issue?: Yes
• Insulin Dose Responsiveness for DLco
  • Time Frame: Baseline, Week 9, Week 51
    Safety Issue?: Yes
• Methacholine PC20
  • Time Frame: Duration of the study
    Safety Issue?: No
• Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used
  • Time Frame: Duration of the study
    Safety Issue?: No
• Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
  • Time Frame: 0 to 1 week to > 9 months
    Safety Issue?: Yes
• Incidence of Severe COPD Exacerbations
  • Time Frame: 0 to 1 week to > 9 months
    Safety Issue?: Yes
• Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires
  • Time Frame: Duration of the study
    Safety Issue?: No
• Change From Baseline in Glycosylated Hemoglobin (HbA1c)
  • Time Frame: Baseline, Weeks 6, 12, 26, 39, and 52
    Safety Issue?: No
• Change From Baseline in Fasting Plasma Glucose
  • Time Frame: Baseline, Weeks 6, 12, 26, 39, 52
    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
    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
    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
    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
    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
    Safety Issue?: No
• Lipids
  • Time Frame: Duration of the study
    Safety Issue?: No
• Hypoglycemic Event Rates
  • Time Frame: 0 to1 month to > 11 months
    Safety Issue?: No
• Severe Hypoglcyemic Event Rates
  • Time Frame: 0 to 1 month to > 11 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 77 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00138671

Study ID Number: A2171030

ClinicalTrials.gov Identifier: NCT00138671

Health Authority: United States: Food and Drug Administration

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