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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00473525

Enrollment

303

Registered

2007-05-15

Start date

2007-07-31

Completion date

2008-06-30

Last updated

2010-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGPlacebo

Placebo QD

DRUGPF-00734200 10 mg QD

10 mg QD

DRUGPF-00734200 20 mg QD

20 mg QD

DRUGPF-00734200 5 mg QD

5 mg QD

DRUGPF-00734200 2 mg QD

2 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
HbA1C levels (%)	12 weeks
Evaluation of Dose Response in HbA1c (%)	12 weeks

Secondary

Measure	Time frame
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

Countries

Colombia, Germany, Italy, Spain, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026