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

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NCT00473525

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00473525
Pfizer
Completed
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin

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[email protected]

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12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Placebo QD
  • Drug: PF-00734200 10 mg QD
    10 mg QD
  • Drug: PF-00734200 20 mg QD
    20 mg QD
  • Drug: PF-00734200 5 mg QD
    5 mg QD
  • Drug: PF-00734200 2 mg QD
    2 mg QD
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-00734200 10 mg QD
    Intervention: Drug: PF-00734200 10 mg QD
  • Experimental: PF-00734200 20 mg QD
    Intervention: Drug: PF-00734200 20 mg QD
  • Experimental: PF-00734200 5 mg QD
    Intervention: Drug: PF-00734200 5 mg QD
  • Experimental: PF-00734200 2 mg QD
    Intervention: Drug: PF-00734200 2 mg QD
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   Germany,   Italy,   Spain,   Sweden,   United States
 
 
NCT00473525
A7941005
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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