CClinicalTrials.gg
CompletedNCT00473525Updated Jun 24, 2010

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

A Phase 2 interventional study of Placebo and PF-00734200 10 mg QD in Diabetes Mellitus, Type 2, sponsored by Pfizer. Completed at 79 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-06-24.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
303
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 303 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
303 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    PF-00734200 10 mg QD

    Drug: PF-00734200 10 mg QD

  • Experimental
    PF-00734200 20 mg QD

    Drug: PF-00734200 20 mg QD

  • Experimental
    PF-00734200 5 mg QD

    Drug: PF-00734200 5 mg QD

  • Experimental
    PF-00734200 2 mg QD

    Drug: PF-00734200 2 mg QD

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

06

What researchers measure

Primary outcomes

  1. HbA1C levels (%)

    Time frame: 12 weeks

  2. Evaluation of Dose Response in HbA1c (%)

    Time frame: 12 weeks

Secondary outcomes

  1. Insulin and Glucose AUC following a mixed meal tolerance test

    Time frame: 12 weeks

  2. Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%

    Time frame: 12 weeks

  3. Incidence of Adverse Events

    Time frame: 12 weeks

07

Study locations

79 sites
  • Pfizer Investigational Site
    Birmingham, Alabama 35209, United States
  • Pfizer Investigational Site
    Gilbert, Arizona 85296, United States
  • Pfizer Investigational Site
    Phoenix, Arizona 85013, United States
  • Pfizer Investigational Site
    Phoenix, Arizona 85016, United States
  • Pfizer Investigational Site
    Jonesboro, Arkansas 72401, United States
  • Pfizer Investigational Site
    Little Rock, Arkansas 72205-6217, United States
  • Pfizer Investigational Site
    Carmichael, California 95608, United States
  • Pfizer Investigational Site
    Chula Vista, California 91911, United States
  • Pfizer Investigational Site
    Fair Oaks, California 95628, United States
  • Pfizer Investigational Site
    Los Angeles, California 90057, United States
  • Pfizer Investigational Site
    National City, California 91950, United States
  • Pfizer Investigational Site
    Paramount, California 90273, United States
  • Pfizer Investigational Site
    Roseville, California 95661, United States
  • Pfizer Investigational Site
    Sacramento, California 95825, United States
  • Pfizer Investigational Site
    DeFuniak Springs, Florida 32435, United States
  • Pfizer Investigational Site
    Destin, Florida 32541, United States
  • Pfizer Investigational Site
    Jacksonville, Florida 32216, United States
  • Pfizer Investigational Site
    New Port Richey, Florida 34652, United States
  • Pfizer Investigational Site
    New Port Richey, Florida 34653, United States
  • Pfizer Investigational Site
    Palm Harbor, Florida 34684, United States
  • Pfizer Investigational Site
    West Palm Beach, Florida 33401, United States
  • Pfizer Investigational Site
    Atlanta, Georgia 30342, United States
  • Pfizer Investigational Site
    Conyers, Georgia 30094, United States
  • Pfizer Investigational Site
    Chicago, Illinois 60607, United States
  • Pfizer Investigational Site
    Skokie, Illinois 60076, United States
  • Pfizer Investigational Site
    Skokie, Illinois 60077, United States
  • Pfizer Investigational Site
    Wheeling, Illinois 60090, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40503, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40504, United States
  • Pfizer Investigational Site
    Brockton, Massachusetts 02301, United States
  • Pfizer Investigational Site
    Worcester, Massachusetts 01602, United States
  • Pfizer Investigational Site
    Ann Arbor, Michigan 48106, United States
  • Pfizer Investigational Site
    Canton, Michigan 48187, United States
  • Pfizer Investigational Site
    Flint, Michigan 48532, United States
  • Pfizer Investigational Site
    Biloxi, Mississippi 39531, United States
  • Pfizer Investigational Site
    Picayune, Mississippi 39466, United States
  • Pfizer Investigational Site
    St. Louis, Missouri 63141, United States
  • Pfizer Investigational Site
    Omaha, Nebraska 68114, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada 89119, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada 89128, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada 89148, United States
  • Pfizer Investigational Site
    Trenton, New Jersey 08611, United States
  • Pfizer Investigational Site
    Cary, North Carolina 27518, United States
  • Pfizer Investigational Site
    Raleigh, North Carolina 27609, United States
  • Pfizer Investigational Site
    Raleigh, North Carolina 27612, United States
  • Pfizer Investigational Site
    Marion, Ohio 43302, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73103, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73119, United States
  • Pfizer Investigational Site
    Carnegie, Pennsylvania 15106, United States
  • Pfizer Investigational Site
    East Providence, Rhode Island 02914, United States
  • Pfizer Investigational Site
    Bartlett, Tennessee 38134, United States
  • Pfizer Investigational Site
    Collierville, Tennessee 38017, United States
  • Pfizer Investigational Site
    Kingsport, Tennessee 37660, United States
  • Pfizer Investigational Site
    Dallas, Texas 75230, United States
  • Pfizer Investigational Site
    Houston, Texas 77023, United States
  • Pfizer Investigational Site
    Houston, Texas 77074, United States
  • Pfizer Investigational Site
    Houston, Texas 77079, United States
  • Pfizer Investigational Site
    Houston, Texas 77081, United States
  • Pfizer Investigational Site
    Irving, Texas 75039, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78229, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78237, United States
  • Pfizer Investigational Site
    Richmond, Virginia 23225, United States
  • Pfizer Investigational Site
    Virginia Beach, Virginia 23455, United States
  • Pfizer Investigational Site
    Milwaukee, Wisconsin 53209, United States
  • Pfizer Investigational Site
    Bogota, Cundinamarca 0, Colombia
  • Pfizer Investigational Site
    Bogota, Cundinamarca, Colombia
  • Pfizer Investigational Site
    Floridablanca, Santander 0, Colombia
  • Pfizer Investigational Site
    Berlin, 10787, Germany
  • Pfizer Investigational Site
    Giengen, 89537, Germany
  • Pfizer Investigational Site
    Hamburg, 21073, Germany
  • Pfizer Investigational Site
    Muenchen, 81241, Germany
  • Pfizer Investigational Site
    Roma, 00161, Italy
  • Pfizer Investigational Site
    Santiago de Compostela, La Coruña 15706, Spain
  • Pfizer Investigational Site
    Alcala de Henares, Madrid 28805, Spain
  • Pfizer Investigational Site
    Valencia, 46009, Spain
  • Pfizer Investigational Site
    Valencia, 46014, Spain
  • Pfizer Investigational Site
    Goteborg, 41665, Sweden
  • Pfizer Investigational Site
    Malmo, 21136, Sweden
  • Pfizer Investigational Site
    Stockholm, 111 57, Sweden
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00473525
Lead sponsor
Pfizer
First posted
May 15, 2007
Start date
Jul 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jun 24, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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