AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00241605

Purpose

This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: rosiglitazone/metformin	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Avandamet

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-Week Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Secondary Outcome Measures:

Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.

Estimated Enrollment:	600
Study Start Date:	June 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.

Exclusion Criteria:

Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
Have a known hypersensitivity to thiazolidinediones or biguanides.
Currently using insulin or any oral anti-diabetic agent other than metformin.
History of metabolic acidosis.
History of substance abuse.
Have active cancer other than localized squamous or basal cell carcinoma.
Chronic disease requiring treatment with corticosteroids.
Other criteria will be evaluated at the screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241605

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	712753/008
Study First Received:	October 17, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00241605
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

AVANDAMET
Metformin
Type 2 diabetes

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009