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

NCT ID: NCT00282945

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Rosiglitazone

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Holon, , Israel

Site Status

Pfizer Investigational Site

Jerusalem, , Israel

Site Status

Countries

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Israel

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001289&StudyName=Beta%20Cell%20Function%20Tests%20Over%20Time%20In%20Patients%20With%20T2dm%20Randomized%20To%20Metformin%20Or%20Rosiglitazone

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9001289

Identifier Type: -

Identifier Source: org_study_id