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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00473525

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 II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

HbA1C levels and evaluation of dose response [ 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 ]
Safety and tolerability of multiple oral doses of study drug [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Placebo QD
PF-00734200 10 mg QD: Experimental	Drug: PF-00734200 10 mg QD 10 mg QD
PF-00734200 20 mg QD: Experimental	Drug: PF-00734200 20 mg QD 20 mg QD
PF-00734200 5 mg QD: Experimental	Drug: PF-00734200 5 mg QD 5 mg QD
PF-00734200 2 mg QD: Experimental	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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7941005
Study First Received:	May 14, 2007
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00473525
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009