12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: PF-00734200 10 mg QD; Drug: PF-00734200 20 mg QD; Drug: PF-00734200 5 mg QD; Drug: PF-00734200 2 mg QD; Drug: Placebo

• Registration Number: NCT00473525
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Study Start: 2007-07
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-24
• Disposition First Posted: 2009-09-28
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• Diagnosis of type 2 diabetes
• Hb1AC >7%-11% inclusive
• Male and females 18-70; females must be post-menopausal
• On a stable dose of metformin hydrochloride

Read More

Exclusion Criteria

• Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
• Women of childbearing potential, pregnant or nursing
• Evidence of diabetic complications with significant end-organ damage

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-00734200 10 mg QD	PF-00734200 10 mg QD	-
PF-00734200 20 mg QD	PF-00734200 20 mg QD	-
PF-00734200 5 mg QD	PF-00734200 5 mg QD	-
PF-00734200 2 mg QD	PF-00734200 2 mg QD	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1C levels (%)	12 weeks
Evaluation of Dose Response in HbA1c (%)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Insulin and Glucose AUC following a mixed meal tolerance test	12 weeks
Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%	12 weeks
Incidence of Adverse Events	12 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Stockholm, Sweden