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Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone

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: NCT00282945
Recruitment Status : Terminated (See statement in Detailed Description.)
First Posted : January 27, 2006
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Rosiglitazone Drug: Metformin Not Applicable

Detailed Description:
The study terminated on 17-Jul-07 due to concerns about long-term cardiovascular safety of Avandia and slow patient enrollment. There were no specific safety issues raised within the trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Analyzing Beta Cell Function Tests Over Time In Patients With Type 2 Diabetes Mellitus Randomized To Metformin Or Rosiglitazone
Study Start Date : January 2006
Actual Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. This study will examine whether biomarkers of B-cell function measured early in the study (1, 3, and/or 6 months) will predict long-term changes in B-cell function (as represented by HOMA-B).

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%.
  • 45-70 years of age.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).
Contacts and Locations
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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): NCT00282945


Locations
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Israel
Pfizer Investigational Site
Holon, Israel, 58100
Pfizer Investigational Site
Jerusalem, Israel, 91120
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00282945    
Other Study ID Numbers: A9001289
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs