A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin

Pfizer1 site in 1 country303 target enrollmentJuly 2007

ConditionsDiabetes Mellitus, Type 2

InterventionsPlacebo PF-00734200 10 mg QD PF-00734200 20 mg QD PF-00734200 5 mg QD PF-00734200 2 mg QD

DrugsPlacebo PF-00734200 10 mg QD PF-00734200 20 mg QD PF-00734200 5 mg QD PF-00734200 2 mg QD

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: Pfizer
Enrollment: 303
Locations: 1
Primary Endpoint: HbA1C levels (%)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

June 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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

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