AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: rosiglitazone/metformin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

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.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary outcome: Change from baseline in HbA1c at week 48.

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

GSK Clinical Trials Call Center, Aldergrove, British Columbia V4W 3L6, Canada

GSK Clinical Trials Call Center, Winnipeg, Manitoba R2J 4A7, Canada

GSK Clinical Trials Call Center, Winnipeg, Manitoba R3A 1M3, Canada

GSK Clinical Trials Call Center, Winnipeg, Manitoba R2H 0R8, Canada

GSK Clinical Trials Call Center, Neguac, New Brunswick E9G 4H3, Canada

GSK Clinical Trials Call Center, Fredericton Junction, New Brunswick E5L 1S1, Canada

GSK Clinical Trials Call Center, Woodstock, New Brunswick E7M 1H1, Canada

GSK Clinical Trials Call Center, St. John's, Newfoundland and Labrador A1A 3R5, Canada

GSK Clinical Trials Call Center, Bay Roberts, Newfoundland and Labrador A0A 1G0, Canada

GSK Clinical Trials Call Center, St. John's, Newfoundland and Labrador A1B 2X2, Canada

GSK Clinical Trials Call Center, Carbonear, Newfoundland and Labrador A1Y 1C4, Canada

GSK Clinical Trials Call Center, Windsor, Nova Scotia B0N 2T0, Canada

GSK Clinical Trials Call Center, Windsor, Nova Scotia B0N 2T1, Canada

GSK Clinical Trials Call Center, Truro, Nova Scotia B2N 1L2, Canada

GSK Clinical Trials Call Center, Hamilton, Ontario L8L 5G8, Canada

GSK Clinical Trials Call Center, Mississauga, Ontario L5B 4A9, Canada

GSK Clinical Trials Call Center, London, Ontario N5Y 3J8, Canada

GSK Clinical Trials Call Center, Sutton, Ontario L0E 1R0, Canada

GSK Clinical Trials Call Center, Oshawa, Ontario L1H 1C5, Canada

GSK Clinical Trials Call Center, Ajax, Ontario L1S 6N2, Canada

GSK Clinical Trials Call Center, Cambridge, Ontario N3C 1Z3, Canada

GSK Clinical Trials Call Center, Innisfail, Ontario L9S 1L2, Canada

GSK Clinical Trials Call Center, Fort Erie, Ontario L2A 1Z3, Canada

GSK Clinical Trials Call Center, Toronto, Ontario M2M 4J, Canada

GSK Clinical Trials Call Center, Smiths Falls, Ontario K7A 2H6, Canada

GSK Clinical Trials Call Center, London, Ontario N6P 1A9, Canada

GSK Clinical Trials Call Center, Mississauga, Ontario L5B 3A8, Canada

GSK Clinical Trials Call Center, Brampton, Ontario L6T 3T1, Canada

GSK Clinical Trials Call Center, Woodbridge, Ontario L4L 8E2, Canada

GSK Clinical Trials Call Center, Ville-la-Salle, Quebec H8N 1X9, Canada

GSK Clinical Trials Call Center, Montreal, Quebec H1M 2M1, Canada

GSK Clinical Trials Call Center, Vaudreuil, Quebec J7V 8P9, Canada

GSK Clinical Trials Call Center, Saint-Henri-de-Levis, Quebec G0R 3E0, Canada

GSK Clinical Trials Call Center, Longueuil, Quebec J4J 3X5, Canada

GSK Clinical Trials Call Center, Saint-Leonard, Quebec H1S 3A9, Canada

GSK Clinical Trials Call Center, Laketon, Quebec G0M 1H0, Canada

GSK Clinical Trials Call Center, Chateauguay, Quebec J6K 3A9, Canada

GSK Clinical Trials Call Center, Longueuil, Quebec J4N 1E1, Canada

GSK Clinical Trials Call Center, Hull, Quebec J8Y 2E2, Canada

GSK Clinical Trials Call Center, Charlesbourg, Quebec G1G 4A2, Canada

GSK Clinical Trials Call Center, Point Claire, Quebec H9R 3J1, Canada

GSK Clinical Trials Call Center, Thetford Mines, Quebec G6G 6H1, Canada

GSK Clinical Trials Call Center, Montreal, Quebec H4N 2W2, Canada

GSK Clinical Trials Call Center, Charlesbourg, Quebec G1H 6P2, Canada

GSK Clinical Trials Call Center, Cowansville, Quebec J2K 2X9, Canada

GSK Clinical Trials Call Center, Quebec City, Quebec G1N 4V3, Canada

GSK Clinical Trials Call Center, Longueuil, Quebec J4N 1L6, Canada

GSK Clinical Trials Call Center, Saskatoon, Saskatchewan S7L 2W1, Canada

GSK Clinical Trials Call Center, Saskatoon, Saskatchewan S7M 0Z6, Canada

Starting date: April 2003
Ending date: December 2005
Last updated: June 9, 2008