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

Sponsor:	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
Diabetes Mellitus, Type 2 Non-Insulin-Dependent Diabetes Mellitus	Drug: rosiglitazone/metformin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

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

U.S. FDA Resources

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)

Intervention Details:

Other Name: rosiglitazone/metformin

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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00241605 History of Changes
Other Study ID Numbers:	712753/008
Study First Received:	October 17, 2005
Last Updated:	June 2, 2011
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Metformin
AVANDAMET
Type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012