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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

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: Inhaled Insulin
  • Inhaled insulin with dose adjusted according to premeal blood glucose
• Drug: Subcutaneous Insulin
  • Subcutaneous insulin with dose adjusted according to premeal blood glucose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Subcutaneous Insulin
• Experimental: Inhaled Insulin

Primary Measures

• Change from baseline in FEV1 and DLco measured 30 minutes following the administration of ipratropium at clinic visits throughout the study.
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• Diabetes control (HbA1c, hypoglycemic events)
  • Time Frame: 12 months
    Safety Issue?: No
• Other PFTs (besides FEV1 and DLco), bronchodilator responsiveness, PFTs measured before and after insulin administration, COPD exacerbations, COPD medication use, BDI/TDI dyspnea index
  • Time Frame: 12 months
    Safety Issue?: Yes

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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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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