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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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:

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

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 June 17, 2013