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Trial record 1 of 1 for:    NCT00618007
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Effect of PF-00734200 in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00618007
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: PF-00734200 30 mg QD Drug: PF-00734200 20 mg QD Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment
Study Start Date : February 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 30 mg QD Drug: PF-00734200 30 mg QD
30 mg QD

Experimental: 20 mg QD Drug: PF-00734200 20 mg QD
20 mg QD

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Fasting Glucose [ Time Frame: 12 weeks ]
  2. Fasting Insulin [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men or women between 18-80 years of age with poorly controlled Type 2 diabetes

Exclusion Criteria:

Type 1 or secondary forms of diabetes Currently using insulin


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618007


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00618007    
Other Study ID Numbers: A7941006
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases