AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

NCT00241605 | Completed Phase 4

• 1 other identifier: 712753/008
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 91

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Metformin; AVANDAMET; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c at week 48.

Secondary Outcomes (1)

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

Interventions

rosiglitazone/metformin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (91)

GSK Investigational Site

Calgary, Alberta, T1Y 3R6, Canada

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GSK Investigational Site

Calgary, Alberta, T1Y 6J2, Canada

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GSK Investigational Site

Calgary, Alberta, T2A 0P9, Canada

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Calgary, Alberta, T2L 2V9, Canada

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Calgary, Alberta, T3B 0M3, Canada

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Calgary, Alberta, T3E 0C5, Canada

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Calgary, Alberta, T3E 7C4, Canada

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Edmonton, Alberta, T5A 4L8, Canada

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Edmonton, Alberta, T6L 6K3, Canada

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Medicine Hat, Alberta, T1A 6N9, Canada

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Aldergrove, British Columbia, V4W 3L6, Canada

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Kelowna, British Columbia, V1Y 3G8, Canada

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Vancouver, British Columbia, V5P 3T7, Canada

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Vancouver, British Columbia, V5X 3T5, Canada

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Vancouver, British Columbia, V7N 4M2, Canada

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Winnipeg, Manitoba, R2H 0R8, Canada

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Winnipeg, Manitoba, R2J 4A7, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Fredericton, New Brunswick, E5L 1S1, Canada

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Houston, New Brunswick, E6E 1H1, Canada

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Neguac, New Brunswick, E9G 4H3, Canada

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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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Carbonear, Newfoundland and Labrador, A1Y 1C4, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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St. John's, Newfoundland and Labrador, A1B 2X2, Canada

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Dartmouth, Nova Scotia, B2W 2S8, Canada

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Halifax, Nova Scotia, B3M 3W8, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Upper Tantallon, Nova Scotia, B3Z 4R4, Canada

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Ajax, Ontario, L1S 6N2, Canada

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Brampton, Ontario, L6T 3T1, Canada

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Brampton, Ontario, L6T 4S5, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Cambridge, Ontario, N3C 1Z3, Canada

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Fort Erie, Ontario, L2A 1Z3, Canada

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Hamilton, Ontario, L8L 5G8, Canada

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Innisfil, Ontario, L9S 1L2, Canada

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Kingston, Ontario, K7M 1W9, Canada

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London, Ontario, N5Y 3J8, Canada

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London, Ontario, N6P 1A9, Canada

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Mississauga, Ontario, L5B 3A8, Canada

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Mississauga, Ontario, L5B 4A9, Canada

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North York, Ontario, M3M 3E5, Canada

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Oakville, Ontario, L6L 2X4, Canada

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Oshawa, Ontario, L1H 1C2, Canada

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Ottawa, Ontario, K2G 6E2, Canada

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Peterborough, Ontario, K9H 1T6, Canada

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Rexdale, Ontario, M9V 4B9, Canada

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Richmond Hill, Ontario, L4C 2N9, Canada

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Scarborough Village, Ontario, M1J 2E5, Canada

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Scarborough Village, Ontario, M1R 1R9, Canada

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Smiths Falls, Ontario, K7A 2H6, Canada

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Sutton, Ontario, L0E 1R0, Canada

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Toronto, Ontario, M2M 4J5, Canada

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Toronto, Ontario, M5G 1E2, Canada

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Windsor, Ontario, B0N 2T0, Canada

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Woodbridge, Ontario, L4L 8E2, Canada

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Woodstock, Ontario, E7M 1H1, Canada

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Woodstock, Ontario, N4S 4H4, Canada

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Brossard, Quebec, J4Z 2K9, Canada

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Charlesbourg, Quebec, G1G 4A2, Canada

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Charlesbourg, Quebec, G1H 6P2, Canada

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Châteauguay, Quebec, J6K 3A9, Canada

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Courcelette, Quebec, G0A 1R1, Canada

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Cowansville, Quebec, J2K 2X9, Canada

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GSK Investigational Site

Hull, Quebec, J8Y 2E2, Canada

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Lambton, Quebec, G0M 1H0, Canada

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Lle Perrot, Quebec, H8Y 3J2, Canada

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Longueuil, Quebec, J4J 3X5, Canada

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Longueuil, Quebec, J4N 1E1, Canada

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GSK Investigational Site

Longueuil, Quebec, J4N 1L6, Canada

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GSK Investigational Site

Montreal, Quebec, H1M 2M1, Canada

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Montreal, Quebec, H4N 2W2, Canada

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GSK Investigational Site

Pierrefonds, Quebec, H8Y 3J2, Canada

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GSK Investigational Site

Pointe-Claire, Quebec, H9R 3J1, Canada

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GSK Investigational Site

Richelieu, Quebec, J3L 4W6, Canada

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Saint-Charles-Borromée, Quebec, J6E 5A9, Canada

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GSK Investigational Site

Saint-Jean-sur-Richelieu, Quebec, J2X 2B2, Canada

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Saint-Léonard, Quebec, H1S 3A9, Canada

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Sainte-Anne-de-Bellevue, Quebec, H9X 1M2, Canada

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Sainte-Catherine, Quebec, J0L 1E0, Canada

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Sainte-Foy, Quebec, G1V 1V6, Canada

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GSK Investigational Site

Sainte-Henri de Levis, Quebec, G0R 3E0, Canada

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GSK Investigational Site

Salaberry-de-Valleyfield, Quebec, J6S 4Z5, Canada

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GSK Investigational Site

Thetford-Mines, Quebec, G6G 6H1, Canada

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GSK Investigational Site

Vaudreuil, Quebec, J7V 8P9, Canada

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GSK Investigational Site

Ville Lasalle, Quebec, H8N 1X9, Canada

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GSK Investigational Site

Saskatoon, Saskatchewan, S7K 1N4, Canada

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GSK Investigational Site

Saskatoon, Saskatchewan, S7L 2W1, Canada

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GSK Investigational Site

Saskatoon, Saskatchewan, S7M 0Z6, Canada

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GSK Investigational Site

Québec, G1N 1E1, Canada

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rosiglitazone-metformin combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 19, 2005
• Study Start: June 25, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 16, 2005
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

CA (91)