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

June 22, 2010 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

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

  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
    • Santander
      • Floridablanca, Santander, Colombia
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10787
        • Pfizer Investigational Site
      • Giengen, Germany, 89537
        • Pfizer Investigational Site
      • Hamburg, Germany, 21073
        • Pfizer Investigational Site
      • Muenchen, Germany, 81241
        • Pfizer Investigational Site
  • Italy
      • Roma, Italy, 00161
        • Pfizer Investigational Site
  • Spain
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Pfizer Investigational Site
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 41665
        • Pfizer Investigational Site
      • Malmo, Sweden, 21136
        • Pfizer Investigational Site
      • Stockholm, Sweden, 111 57
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72205-6217
        • Pfizer Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Pfizer Investigational Site
      • Chula Vista, California, United States, 91911
        • Pfizer Investigational Site
      • Fair Oaks, California, United States, 95628
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90057
        • Pfizer Investigational Site
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • Paramount, California, United States, 90273
        • Pfizer Investigational Site
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95825
        • Pfizer Investigational Site
    • Florida
      • DeFuniak Springs, Florida, United States, 32435
        • Pfizer Investigational Site
      • Destin, Florida, United States, 32541
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34653
        • Pfizer Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Conyers, Georgia, United States, 30094
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Pfizer Investigational Site
      • Skokie, Illinois, United States, 60077
        • Pfizer Investigational Site
      • Skokie, Illinois, United States, 60076
        • Pfizer Investigational Site
      • Wheeling, Illinois, United States, 60090
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01602
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Pfizer Investigational Site
      • Canton, Michigan, United States, 48187
        • Pfizer Investigational Site
      • Flint, Michigan, United States, 48532
        • Pfizer Investigational Site
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • Pfizer Investigational Site
      • Picayune, Mississippi, United States, 39466
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89148
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89119
        • Pfizer Investigational Site
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
    • Ohio
      • Marion, Ohio, United States, 43302
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73119
        • Pfizer Investigational Site
    • Pennsylvania
      • Carnegie, Pennsylvania, United States, 15106
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Pfizer Investigational Site
    • Tennessee
      • Bartlett, Tennessee, United States, 38134
        • Pfizer Investigational Site
      • Collierville, Tennessee, United States, 38017
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77079
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77074
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77023
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77081
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75039
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78237
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 QD
Experimental: PF-00734200 10 mg QD
Drug: PF-00734200 10 mg QD
10 mg QD
Experimental: PF-00734200 20 mg QD
Drug: PF-00734200 20 mg QD
20 mg QD
Experimental: PF-00734200 5 mg QD
Drug: PF-00734200 5 mg QD
5 mg QD
Experimental: PF-00734200 2 mg QD
Drug: PF-00734200 2 mg QD
2 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1C levels (%)
Time Frame: 12 weeks
12 weeks
Evaluation of Dose Response in HbA1c (%)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: 12 weeks
12 weeks
Insulin and Glucose AUC following a mixed meal tolerance test
Time Frame: 12 weeks
12 weeks
Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%
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

July 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7941005

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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