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Completed

NCT Number: NCT00473525

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo QD

PF-00734200 10 mg QD

Drug

10 mg QD

PF-00734200 20 mg QD

Drug

20 mg QD

PF-00734200 5 mg QD

Drug

5 mg QD

PF-00734200 2 mg QD

Drug

2 mg QD

Primary outcomes

  1. HbA1C levels (%)

    Time frame: 12 weeks

  2. Evaluation of Dose Response in HbA1c (%)

    Time frame: 12 weeks

Secondary outcomes

  1. Insulin and Glucose AUC following a mixed meal tolerance test

    Time frame: 12 weeks

  2. Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%

    Time frame: 12 weeks

  3. Incidence of Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 15, 2007
Registry last updated
Jun 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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