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NCT00282945 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Analyzing Beta Cell Function Tests Over Time In Patients With Type 2 Diabetes Mellitus Randomized To Metformin Or Rosiglitazone

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00282945
Other study ID # A9001289
Secondary ID
Status Terminated
Phase N/A
First received January 25, 2006
Last updated October 9, 2008
Start date January 2006
Est. completion date October 2007

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 29
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 70 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Rosiglitazone

• Metformin

Locations
Country Name City State
Israel Pfizer Investigational Site Holon
Israel Pfizer Investigational Site Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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).
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