A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
Condition: Impaired Glucose Tolerance; Diabetes
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID
Intervention type(s): Drug
Intervention description(s): [Rosiglitazone 2mg/ Metformin 500mg] twice daily
Other intervention name(s): Avandamet
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes; Prevention.; Rosiglitazone; Metformin; Lifestyle; Impaired glucose Tolerance