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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 14, 2007

Last Updated Date

October 6, 2008

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

HbA1C levels and evaluation of dose response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00473525 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Evaluate the safety and tolerability of multiple oral doses of study drug in subjects with Type 2 Diabetes Mellitus
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%

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

303

Completion Date

July 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Colombia, Germany, Italy, Spain, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00473525

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.