A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks

Phase 2

Terminated

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00427401
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose concentration).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-29
• Study Start: 2007-02
• Study Completion: 2007-06
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Type 2 diabetes mellitus
• HbA1c > 7.5%.

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Exclusion Criteria

• Recent (within the past 12 months) evidence or history of unstable concomitant disease.
• Treatment with any oral hypoglycemic agent within 3 months before enrollment.
• The exception to these criteria is that subjects who are currently taking metformin hydrochloride, in a stable dose (that is no changes in dose) for treatment of their diabetes within the past 3 months or longer of enrollment may participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary end point is glucose lowering (24 hour mean glucose concentration).

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium