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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00473525
First received: May 14, 2007
Last updated: June 22, 2010
Last verified: June 2010

May 14, 2007
June 22, 2010
July 2007
June 2008   (final data collection date for primary outcome measure)
  • HbA1C levels (%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluation of Dose Response in HbA1c (%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 weeks of HbA1C levels and evaluation of dose response in subjects with Type 2 Diabetes on a stable dose of metformin hydrochloride
Complete list of historical versions of study NCT00473525 on ClinicalTrials.gov Archive Site
  • Insulin and Glucose AUC following a mixed meal tolerance test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ADA glycemic goal of Hb A1c <7% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 weeks of insulin AUC following a mixed meal tolerance test in subjects with Type 2 Diabetes
  • Evaluate proportion of subjects achieving ADA glycemic goal of Hb A1c <7%
  • Evaluate the safety and tolerability of multiple oral doses of study drug in subjects with Type 2 Diabetes Mellitus
Not Provided
Not Provided
 
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Placebo QD
  • Drug: PF-00734200 10 mg QD
    10 mg QD
  • Drug: PF-00734200 20 mg QD
    20 mg QD
  • Drug: PF-00734200 5 mg QD
    5 mg QD
  • Drug: PF-00734200 2 mg QD
    2 mg QD
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-00734200 10 mg QD
    Intervention: Drug: PF-00734200 10 mg QD
  • Experimental: PF-00734200 20 mg QD
    Intervention: Drug: PF-00734200 20 mg QD
  • Experimental: PF-00734200 5 mg QD
    Intervention: Drug: PF-00734200 5 mg QD
  • Experimental: PF-00734200 2 mg QD
    Intervention: Drug: PF-00734200 2 mg QD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Colombia,   Germany,   Italy,   Spain,   Sweden
 
NCT00473525
A7941005
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP