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Clinical Trials/NCT00287066
NCT00287066TerminatedPhase 3

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

Pfizer1 site in 1 country22 target enrollmentStarted: February 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Pfizer
Enrollment
22
Locations
1
Primary Endpoint
18F-labeled glucose uptake in muscle
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Diabetes mellitus Type 1

Exclusion Criteria

  • •Asthma, COPD

Outcomes

Primary Outcomes

18F-labeled glucose uptake in muscle

Secondary Outcomes

  • Glucose turnover overnight Insulin pharmacokinetics

Investigators

Sponsor
Pfizer
Sponsor Class
Industry

Study Sites (1)

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