A Lifestyle and Combination Medication Therapy Diabetes Prevention Study

CAnadian Normoglycemia Outcomes Evaluation Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID

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
• Enrollment (Actual): 207
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 4X8
      • UWO Research Park
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Avandamet [ Rosuglitazone 2 and Metformin 500]	Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID; [Rosiglitazone 2mg/ Metformin 500mg] twice daily; Other Names: Avandamet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels	Dec 2009

Secondary Outcome Measures

Outcome Measure	Time Frame
Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually	Dec2009

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborators: University of Western Ontario, Canada
• Investigators: Principal Investigator: Bernard Zinman, MD, Mount Sinai Hospital; Principal Investigator: Stewart Harris, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: June 30, 2005
• First Submitted That Met QC Criteria: June 30, 2005
• First Posted (Estimate): July 1, 2005

Study Record Updates

• Last Update Posted (Estimate): May 24, 2012
• Last Update Submitted That Met QC Criteria: May 22, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Diabetes; Metformin; Rosiglitazone; Lifestyle; Impaired glucose Tolerance; Prevention.
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Rosiglitazone
• Other Study ID Numbers: CANOE