A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
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|ClinicalTrials.gov Identifier: NCT00116922|
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : May 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Impaired Glucose Tolerance Diabetes||Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID||Phase 3|
The CANOE Study CAnadian Normoglycemia Outcomes Evaluation Study
It is now well accepted that the 21st Century will be characterized by a global epidemic of Type 2 diabetes mellitus [Type 2DM]. To deal with this major health crisis, several strategies have been proposed. These include efforts that focus on the primary prevention of diabetes, attempts at implementing effective management of diabetes once it develops, and the institution of appropriate proven therapies for established diabetic complications. The CANOE study focuses on a primary prevention strategy. The study is designed to evaluate the effect of pharmacological therapy combined with a healthy living lifestyle intervention on Canadian individuals who are at high risk for this metabolic condition because they have IGT.
- To determine if treatment with Avandamet, in addition to a healthy living lifestyle program, will prevent the development of Type 2 diabetes in Canadians at high risk for this metabolic disorder;
- To determine if treatment with Avandamet, in addition to a healthy living lifestyle program will improve cardiovascular risk factors associated with IGT.
CANOE is a moderately sized, randomized, double-blind controlled trial to determine if Avandamet will decrease the development of diabetes in individuals at high risk for this condition. A total of 200 patients will be followed for an average follow up of 4 years (range 3 - 5 years). Active treatment with Avandamet (Metformin 500 mg / Rosiglitazone 2 mg) administered as one capsule twice daily will be compared to matched placebo.
All study participants will receive a lifestyle intervention program based on the latest national evidence-based guidelines recommended by the Canadian Diabetes Association (Can J Diabetes, Vol 27 Suppl 2, 2003).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CAnadian Normoglycemia Outcomes Evaluation Study|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Active Comparator: A
Avandamet [ Rosuglitazone 2 and Metformin 500]
Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID
[Rosiglitazone 2mg/ Metformin 500mg] twice daily
Other Name: Avandamet
- Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels [ Time Frame: Dec 2009 ]
- Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually [ Time Frame: Dec2009 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116922
|UWO Research Park|
|London, Ontario, Canada, N6G 4X8|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Bernard Zinman, MD||MOUNT SINAI HOSPITAL|
|Principal Investigator:||Stewart Harris, MD||University of Western Ontario, Canada|