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
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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014