A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
Overview[ - collapse ][ - ]
| Purpose | It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years. |
|---|---|
| Condition | Impaired Glucose Tolerance Diabetes |
| Intervention | Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID |
| Phase | Phase 3 |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Responsible Party | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| ClinicalTrials.gov Identifier | NCT00116922 |
| First Received | June 30, 2005 |
| Last Updated | May 22, 2012 |
| Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 30, 2005 |
|---|---|
| Last Updated Date | May 22, 2012 |
| Start Date | June 2004 |
| Estimated Primary Completion Date | January 2010 |
| Current Primary Outcome Measures | Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels [Time Frame: Dec 2009] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually [Time Frame: Dec2009] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Lifestyle and Combination Medication Therapy Diabetes Prevention Study |
|---|---|
| Official Title | CAnadian Normoglycemia Outcomes Evaluation Study |
| Brief Summary | It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years. |
| Detailed Description | 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. OBJECTIVES - 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. STUDY DESIGN 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 |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition |
|
| Intervention | Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID [Rosiglitazone 2mg/ Metformin 500mg] twice daily Other Names: Avandamet |
| Study Arm (s) | Active Comparator: A Avandamet [ Rosuglitazone 2 and Metformin 500] |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 207 |
| Estimated Completion Date | January 2010 |
| Estimated Primary Completion Date | January 2010 |
| Eligibility Criteria | Inclusion Criteria: - Residents of Ontario - Age 18-75 - IGT on OGTT Exclusion Criteria: - Current use of Metformin or Rosiglitazone - Prior use of medication to treat diabetes except gestational diabetes - Use of drugs known to exacerbate glucose tolerance - History of diabetes except gestational diabetes - Liver function studies greater the 2.5x normal - Creatinine clearance less than 60 ml/min |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00116922 |
|---|---|
| Other Study ID Numbers | CANOE |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Study Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Collaborators | University of Western Ontario, Canada |
| Investigators | Principal Investigator: Bernard Zinman, MD Mount Sinai Hospital, New YorkPrincipal Investigator: Stewart Harris, MD University of Western Ontario, Canada |
| Verification Date | May 2012 |
Locations[ + expand ][ + ]
| UWO Research Park | London, Ontario, Canada, N6G 4X8 |
|---|---|
| Mount Sinai Hospital | Toronto, Ontario, Canada, M5G 1X5 |