Effect of PF-00734200 in Subjects With Type 2 Diabetes

June 9, 2011 updated by: Pfizer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment

To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

289

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4M6
        • Pfizer Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • Pfizer Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-1711
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Pfizer Investigational Site
      • Litchfield Park, Arizona, United States, 85340
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85051
        • Pfizer Investigational Site
    • California
      • Artesia, California, United States, 90701
        • Pfizer Investigational Site
      • Cerritos, California, United States, 90703
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Greenbrea, California, United States, 94904
        • Pfizer Investigational Site
      • Huntington Beach, California, United States, 92648
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90057
        • Pfizer Investigational Site
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • Valley Village, California, United States, 91607
        • Pfizer Investigational Site
      • West Covina, California, United States, 91790
        • Pfizer Investigational Site
    • Florida
      • DeFuniak Springs, Florida, United States, 32435
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33169
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Pinecrest, Florida, United States, 33156
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33702
        • Pfizer Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Pfizer Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Pfizer Investigational Site
      • Oxon Hill, Maryland, United States, 20745
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Pfizer Investigational Site
      • Bay City, Michigan, United States, 48706
        • Pfizer Investigational Site
      • Canton, Michigan, United States, 48187
        • Pfizer Investigational Site
      • Troy, Michigan, United States, 48098
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39209
        • Pfizer Investigational Site
      • Picayune, Mississippi, United States, 39466
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63117
        • Pfizer Investigational Site
      • St. Peters, Missouri, United States, 63376
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Pfizer Investigational Site
      • Trenton, New Jersey, United States, 08611
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • Syracuse, New York, United States, 13210
        • Pfizer Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Marion, Ohio, United States, 43302
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Pfizer Investigational Site
      • Florence, South Carolina, United States, 29501
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79935
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77023
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77081
        • Pfizer Investigational Site
      • Hurst, Texas, United States, 76054
        • Pfizer Investigational Site
      • Odessa, Texas, United States, 79761
        • Pfizer Investigational Site
      • Pearland, Texas, United States, 77584
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201-5018
        • Pfizer Investigational Site
    • Virginia
      • Ettrick, Virginia, United States, 23803
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23225
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23454
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Pfizer Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men or women between 18-80 years of age with poorly controlled Type 2 diabetes

Exclusion Criteria:

Type 1 or secondary forms of diabetes Currently using insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: 30 mg QD
Drug: PF-00734200 30 mg QD
30 mg QD
Experimental: 20 mg QD
Drug: PF-00734200 20 mg QD
20 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Insulin
Time Frame: 12 weeks
12 weeks
Fasting Glucose
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7941006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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