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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: METFORMIN (Drug); ROSIGLITAZONE (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CTgov Call Center, Phone: 1-800-718-1021

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.

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

Study design: Interventional, Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study

Primary outcome: 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).

Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Both.

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).

Pfizer CTgov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Jerusalem, Israel; Recruiting

Pfizer Investigational Site, HOLON, Israel; Recruiting

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

Starting date: January 2006
Last updated: April 30, 2007