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

This study has been terminated.
(See statement in Detailed Description.)
Information provided by:
Pfizer Identifier:
First received: January 25, 2006
Last updated: October 9, 2008
Last verified: October 2008
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 Intervention
Type 2 Diabetes Mellitus Drug: Rosiglitazone Drug: Metformin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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).

Enrollment: 29
Study Start Date: January 2006
Study Completion Date: October 2007
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00282945

Pfizer Investigational Site
Holon, Israel, 58100
Pfizer Investigational Site
Jerusalem, Israel, 91120
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00282945     History of Changes
Other Study ID Numbers: A9001289
Study First Received: January 25, 2006
Last Updated: October 9, 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 22, 2017