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

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ClinicalTrials.gov Identifier: NCT00359112
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : May 18, 2009
Sponsor:
Information provided by:
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Non-Insulin-Dependent Diabetes Mellitus Drug: metformin Drug: sulphonylurea Drug: Avandamet Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : February 2004

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: metformin
  • Drug: sulphonylurea
  • Drug: Avandamet
    Other Names:
    • metformin
    • sulphonylurea


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

Secondary Outcome Measures :
  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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359112


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, DM, FRCP GlaxoSmithKline

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00359112     History of Changes
Other Study ID Numbers: AVM100264
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009

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