Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279045

Enrollment

4426

Registered

2006-01-19

Start date

2000-01-03

Completion date

2006-06-19

Last updated

2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes monotherapy treatment naive

Brief summary

The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Interventions

DRUGRosiglitazone

DRUGglyburide

DRUGmetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Newly diagnosed patients (\< 3years) with type 2 diabetes. * Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening. * No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria

* History of lactic acidosis. * Anemia (\<11g for males, \<10 g for females). * Unstable or severe NY Heart Association-class 3 or 4. * Any NY Heart Association congestive heart failure. * Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

Design outcomes

Primary

Measure	Time frame
Time from randomization to the primary action point (monotherapy failure).	—

Secondary

Measure	Time frame
Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).	—

Countries

Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026