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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 303
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473525

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00473525     History of Changes
Other Study ID Numbers: A7941005
Study First Received: May 14, 2007
Last Updated: June 22, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014