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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00473525
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: PF-00734200 10 mg QD Drug: PF-00734200 20 mg QD Drug: PF-00734200 5 mg QD Drug: PF-00734200 2 mg QD Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

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



Primary Outcome Measures :
  1. HbA1C levels (%) [ Time Frame: 12 weeks ]
  2. Evaluation of Dose Response in HbA1c (%) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473525


  Show 79 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00473525     History of Changes
Other Study ID Numbers: A7941005
First Posted: May 15, 2007    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs