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

NCT ID: NCT00473525

Last Updated: 2010-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo QD

PF-00734200 10 mg QD

Group Type EXPERIMENTAL

PF-00734200 10 mg QD

Intervention Type DRUG

10 mg QD

PF-00734200 20 mg QD

Group Type EXPERIMENTAL

PF-00734200 20 mg QD

Intervention Type DRUG

20 mg QD

PF-00734200 5 mg QD

Group Type EXPERIMENTAL

PF-00734200 5 mg QD

Intervention Type DRUG

5 mg QD

PF-00734200 2 mg QD

Group Type EXPERIMENTAL

PF-00734200 2 mg QD

Intervention Type DRUG

2 mg QD

Interventions

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Placebo

Placebo QD

Intervention Type DRUG

PF-00734200 10 mg QD

10 mg QD

Intervention Type DRUG

PF-00734200 20 mg QD

20 mg QD

Intervention Type DRUG

PF-00734200 5 mg QD

5 mg QD

Intervention Type DRUG

PF-00734200 2 mg QD

2 mg QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Chula Vista, California, United States

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Fair Oaks, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Paramount, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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DeFuniak Springs, Florida, United States

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Destin, Florida, United States

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Jacksonville, Florida, United States

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New Port Richey, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Conyers, Georgia, United States

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Chicago, Illinois, United States

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Skokie, Illinois, United States

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Skokie, Illinois, United States

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Wheeling, Illinois, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Brockton, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Canton, Michigan, United States

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Flint, Michigan, United States

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Biloxi, Mississippi, United States

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Picayune, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Trenton, New Jersey, United States

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Cary, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Marion, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Carnegie, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Bartlett, Tennessee, United States

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Collierville, Tennessee, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Milwaukee, Wisconsin, United States

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Bogota, Cundinamarca, Colombia

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Bogota, Cundinamarca, Colombia

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Floridablanca, Santander Department, Colombia

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Berlin, , Germany

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Giengen an der Brenz, , Germany

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Hamburg, , Germany

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München, , Germany

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Roma, , Italy

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Santiago de Compostela, La Coruña, Spain

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Alcalá de Henares, Madrid, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Gothenburg, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Countries

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United States Colombia Germany Italy Spain Sweden

Related Links

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Other Identifiers

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A7941005

Identifier Type: -

Identifier Source: org_study_id

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