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OpenTrials
Completed

NCT Number: NCT00044460

Efficacy and Safety In Poorly Controlled Type 2 Diabetics

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

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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

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Drug-naive.
  • Laboratory test result for HbA1c of greater than or equal to 10%.
  • Written informed consent.

Exclusion criteria

  • Prior use of antidiabetic medications within 3 months of screening.
  • Fluid retention (edema).
  • Significant liver disease.
  • Low red blood cells (anemia).
  • Severe or unstable angina (chest pain).
  • Congestive heart failure.
  • Severe high blood pressure.
  • Alcohol or drug abuse.
  • Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Treatment and study plan

rosiglitazone

Drug

Primary outcomes

  1. Change in HbA1c from baseline to Week 24.

Secondary outcomes

  1. Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Aug 30, 2002
Registry last updated
Oct 9, 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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