AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241605
• Other study ID #: 712753/008
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2005
• Last updated: March 19, 2018
• Start date: June 25, 2003
• Est. completion date: December 16, 2005

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 16, 2005
• Est. primary completion date: December 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rosiglitazone/metformin

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Ajax	Ontario
Canada	GSK Investigational Site	Aldergrove	British Columbia
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Brossard	Quebec
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Cambridge	Ontario
Canada	GSK Investigational Site	Carbonear	Newfoundland and Labrador
Canada	GSK Investigational Site	Charlesbourg	Quebec
Canada	GSK Investigational Site	Charlesbourg	Quebec
Canada	GSK Investigational Site	Chateauguay	Quebec
Canada	GSK Investigational Site	Courcelette	Quebec
Canada	GSK Investigational Site	Cowansville	Quebec
Canada	GSK Investigational Site	Dartmouth	Nova Scotia
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Fort Erie	Ontario
Canada	GSK Investigational Site	Fredericton	New Brunswick
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Houston	New Brunswick
Canada	GSK Investigational Site	Hull	Quebec
Canada	GSK Investigational Site	Innisfil	Ontario
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Lambton	Quebec
Canada	GSK Investigational Site	Lle Perrot	Quebec
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Longueuil	Quebec
Canada	GSK Investigational Site	Longueuil	Quebec
Canada	GSK Investigational Site	Longueuil	Quebec
Canada	GSK Investigational Site	Medicine Hat	Alberta
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Neguac	New Brunswick
Canada	GSK Investigational Site	North York	Ontario
Canada	GSK Investigational Site	Oakville	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Peterborough	Ontario
Canada	GSK Investigational Site	Pierrefonds	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Québec
Canada	GSK Investigational Site	Rexdale	Ontario
Canada	GSK Investigational Site	Richelieu	Quebec
Canada	GSK Investigational Site	Richmond Hill	Ontario
Canada	GSK Investigational Site	Saint Charles Borromee	Quebec
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Saint Leonard	Quebec
Canada	GSK Investigational Site	Saint-Jean sur Richelieu	Quebec
Canada	GSK Investigational Site	Sainte Anne De Bellevue	Quebec
Canada	GSK Investigational Site	Sainte Catherine	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Sainte-Henri De Levis	Quebec
Canada	GSK Investigational Site	Salaberry-De-Valleyfield	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Scarborough	Ontario
Canada	GSK Investigational Site	Scarborough	Ontario
Canada	GSK Investigational Site	Smiths Falls	Ontario
Canada	GSK Investigational Site	Sutton	Ontario
Canada	GSK Investigational Site	Thetford Mines	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Upper Tantallon	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Vaudreuil	Quebec
Canada	GSK Investigational Site	Ville Lasalle	Quebec
Canada	GSK Investigational Site	Windsor	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Canada	GSK Investigational Site	Winnipeg	Manitoba
Canada	GSK Investigational Site	Winnipeg	Manitoba
Canada	GSK Investigational Site	Woodbridge	Ontario
Canada	GSK Investigational Site	Woodstock	Ontario
Canada	GSK Investigational Site	Woodstock	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at week 48.
Secondary	Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.