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Completed

NCT Number: NCT00279045

Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rosiglitazone

Drug

Glyburide

Drug

metformin

Drug

Other names: glyburide, Rosiglitazone

Primary outcomes

  1. Time from randomization to the primary action point (monotherapy failure).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Jan 19, 2006
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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