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Completed

NCT Number: NCT00359112

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

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Key information

Conditions

Non-Insulin-Dependent Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body mass index > or = to 25 kg/m2.
  • HbA1c > or =7% and < or =10% at screening.
  • FPG > or = 7.0mmol/L (126mg/dL) at visit 2.
  • Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
  • Female subjects must be postmenopausal or using effective contraceptive measures.

Exclusion criteria

  • Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
  • Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
  • Subjects with a history of severe hypoglycaemia.
  • Renal disease or renal dysfunction.
  • Presence of clinically significant hepatic disease.
  • Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
  • Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.

Treatment and study plan

metformin

Drug

Sulphonylurea

Drug

Avandamet

Drug

Other names: metformin, sulphonylurea

Primary outcomes

  1. Change in HbA1c level from baseline following 52 weeks of treatment.

Secondary outcomes

  1. Change in FPG (fasting plasma glucose)

  2. insulin sensitivity

  3. beta cell function

  4. change in PAI-1

  5. CRP

  6. number of hypoglycaemic events

  7. Change in 24 hr ABPM

  8. Diabetes treatment satisfaction.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

Important dates

Study start
2004
First posted
Aug 1, 2006
Registry last updated
May 18, 2009

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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