A Lifestyle and Combination Medication Therapy Diabetes Prevention Study

This study has been completed.
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (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
  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 Intervention Phase
Impaired Glucose Tolerance
Diabetes
Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CAnadian Normoglycemia Outcomes Evaluation Study

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

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 ]

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 ]

Enrollment: 207
Study Start Date: June 2004
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116922

Locations
Canada, Ontario
UWO Research Park
London, Ontario, Canada, N6G 4X8
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
University of Western Ontario, Canada
Investigators
Principal Investigator: Bernard Zinman, MD Mount Sinai Hospital, New York
Principal Investigator: Stewart Harris, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00116922     History of Changes
Other Study ID Numbers: CANOE
Study First Received: June 30, 2005
Last Updated: May 22, 2012
Health Authority: Canada: Health Canada

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Diabetes
Prevention.
Rosiglitazone
Metformin
Lifestyle
Impaired glucose Tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014