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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359112
First received: July 28, 2006
Last updated: May 15, 2009
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
 Drug: metformin
Drug: sulphonylurea
Drug: Avandamet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in HbA1c level from baseline following 52 weeks of treatment.

Secondary Outcome Measures:
  • Change in FPG (fasting plasma glucose)
  • insulin sensitivity
  • beta cell function
  • change in PAI-1
  • CRP
  • number of hypoglycaemic events
  • Change in 24 hr ABPM
  • Diabetes treatment satisfaction.

Estimated Enrollment: 544
Study Start Date: February 2004
Intervention Details:
    Drug: metformin Drug: sulphonylurea Drug: Avandamet
    Other Names:
    • metformin
    • sulphonylurea
    • Avandamet
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359112

  Show 142 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, DM, FRCP GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00359112     History of Changes
Other Study ID Numbers: AVM100264
Study First Received: July 28, 2006
Last Updated: May 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Type 2 diabetes
overweight
AVANDAMET
metformin
sulphonylurea

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013