A Lifestyle and Combination Medication Therapy Diabetes Prevention Study

Diabetes Clinical Trial

Official title:

CAnadian Normoglycemia Outcomes Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116922
• Other study ID #: CANOE
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: May 22, 2012
• Start date: June 2004
• Est. completion date: January 2010

Study information

• Verified date: May 2012
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID
[Rosiglitazone 2mg/ Metformin 500mg] twice daily

Locations

Country	Name	City	State
Canada	UWO Research Park	London	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels		Dec 2009	No
Secondary	Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually		Dec2009	No