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: October 2008

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

• 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
• Diabetes control (HbA1c, hypoglycemic events)
  • Time Frame: 12 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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

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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