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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: PF-00734200 10 mg QD; Drug: PF-00734200 20 mg QD; Drug: Placebo; Drug: PF-00734200 2 mg QD; Drug: PF-00734200 5 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00473525

A7941005

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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303 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-00734200 10 mg QD

Experimental group

Treatment:

Drug: PF-00734200 10 mg QD

PF-00734200 20 mg QD

Experimental group

Treatment:

Drug: PF-00734200 20 mg QD

PF-00734200 5 mg QD

Experimental group

Treatment:

Drug: PF-00734200 5 mg QD

PF-00734200 2 mg QD

Experimental group

Treatment:

Drug: PF-00734200 2 mg QD