Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: Placebo; Biological: PF-04603629

• Registration Number: NCT00638313
• Lead Sponsor: Pfizer

Brief Summary

PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study Completion: 2008-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Last Update Submitted: 2009-07-30
• Last Update Posted: 2009-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Type 2 diabetes mellitus
• Hb A1c lower or equal to 11%

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Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Evidence of diabetic complications with significant end-organ damage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF-04603629	PF-04603629	-

Primary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.	1 week per dose group
To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.	1 week per dose group
To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.	1 week per dose group

Secondary Outcome Measures

Name	Time	Method
No secondary outcomes listed in the protocol.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States