A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition

Open-Label Randomized Two-Way Crossover Pilot Study To Estimate The Effects Of Inhaled Versus IV Infusion Of Human Insulin With Regards To Glucose Disposal In Subjects With Type 1 Diabetes Mellitus

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
Brief Summary

To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

Detailed Description

The study was terminated on Oct. 28, 2007. The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.

Overall Status Terminated
Start Date February 2006
Completion Date March 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
18F-labeled glucose uptake in muscle
Secondary Outcome
Measure Time Frame
Glucose turnover overnight Insulin pharmacokinetics
Enrollment 22
Condition
Intervention

Intervention Type: Drug

Intervention Name: Inhaled Human Insulin

Intervention Type: Drug

Intervention Name: Regular Human Insulin

Eligibility

Criteria:

Inclusion Criteria:

- Diabetes mellitus Type 1

Exclusion Criteria:

- Asthma, COPD

- Smoking

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility: Pfizer Investigational Site
Location Countries

United States

Verification Date

April 2007

Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov