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

This study has been completed.

First Received: July 28, 2006 Last Updated: May 15, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00359112

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Avandamet Metformin Metformin hydrochloride

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

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:	GSK ( Study Director )
Study ID Numbers:	AVM100264
Study First Received:	July 28, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00359112 History of Changes
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:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010