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Sponsors and Collaborators: |
Canadian Heart Research Centre GlaxoSmithKline |
Information provided by: | Canadian Heart Research Centre |
ClinicalTrials.gov Identifier: | NCT00131664 |
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
Condition | Intervention | Phase |
Type 2 Diabetes Mellitus |
Drug: Avandia, Amaryl, Avandamet, Metformin |
Phase III |
MedlinePlus related topics: | Diabetes |
ChemIDplus related topics: | Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Avandamet Glimepiride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin: A 48-Week Randomized, Open-Label, Multicentre Phase IIIB Study to Compare the Effectiveness of Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patients |
Enrollment: | 391 |
Study Start Date: | September 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Avandamet 2mg/500mg BID titration up to 4mg/1000mg BID over 6 months
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Drug: Avandia, Amaryl, Avandamet, Metformin
Avandamet 2/500mg BID to 4mg/1000mg BID;Avandia+Amaryl 4mg+1mg OD up to 8mg+2mg OD over 6 months or Metformin 500mg BID up to 1000mg over 6 months
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2: Active Comparator
Avandia + Amaryl 4mg + 1mg OD titration up to 8mg +2mf OD over 6 months
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Drug: Avandia, Amaryl, Avandamet, Metformin
Avandamet 2/500mg BID to 4mg/1000mg BID;Avandia+Amaryl 4mg+1mg OD up to 8mg+2mg OD over 6 months or Metformin 500mg BID up to 1000mg over 6 months
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3: Active Comparator
Metformin 500mg BID titration up to 1000mg BID over 6 months
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Drug: Avandia, Amaryl, Avandamet, Metformin
Avandamet 2/500mg BID to 4mg/1000mg BID;Avandia+Amaryl 4mg+1mg OD up to 8mg+2mg OD over 6 months or Metformin 500mg BID up to 1000mg over 6 months
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AvandametTM combines two oral antihyperglycemic agents, rosiglitazone maleate and metformin hydrochloride, with different but complementary mechanisms of action to improve glycemic control while reducing circulating insulin levels in patients with type 2 diabetes. AvandiaTM and AmarylTM combine two antidiabetic agents, rosiglitazone maleate and glimepiride. Glimepiride is an effective antihyperglycemic agent which has a low incidence of hypoglycemia, symptomatic hypoglycemia, severe hypoglycemia, and confirmed hypoglycemia. Subjects in this study who are inadequately controlled on diet, exercise and a submaximal dose of metformin or SU will be randomized to either a combination of metformin plus rosiglitazone (AvandametTM) or a combination of AvandiaTM + AmarylTM or a Metformin monotherapy arm. As per the Canadian Diabetes Association guidelines, their fasting plasma glucose and A1C to be 7 (mmol/L/%) or less throughout the study. If the subject does not achieve the target then either AvandametTM or AvandiaTM and AmarylTM or Metformin will be up-titrated in an effort to reach this CDA recommended target. This study will attempt to demonstrate that the either combination arm of rosiglitazone plus metformin (AvandametTM) or the other combination arm of AvandiaTM + AmarylTM will provide greater glycemic control while avoiding the side-effects associated with the use of maximal dose metformin.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A1C criteria at screening:
Exclusion Criteria:
Canada, Ontario | |||||
Canadian Heart Research Centre | |||||
toronto, Ontario, Canada, m5b 2p9 |
Canadian Heart Research Centre |
GlaxoSmithKline |
Principal Investigator: | robert josse, md | University of Toronto |
coordinating centre web site 
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Responsible Party: | Canadian Heart Research Centre ( Dr. Anatoly Langer, Chair CHRC ) |
Study ID Numbers: | AVM103436 |
First Received: | August 17, 2005 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00131664 |
Health Authority: | Canada: Health Canada |
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