A Lifestyle and Combination Medication Therapy Diabetes Prevention Study

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00116922

Collaborator

University of Western Ontario, Canada (Other)

207

Enrollment

Locations

Arm

Duration (Months)

103.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Impaired Glucose Tolerance Diabetes	Drug: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

207 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

CAnadian Normoglycemia Outcomes Evaluation Study

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels [Dec 2009]

Secondary Outcome Measures

Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually [Dec2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UWO Research Park	London	Ontario	Canada	N6G 4X8
2	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
Principal Investigator: Stewart Harris, MD, University of Western Ontario, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

ClinicalTrials.gov Identifier:

NCT00116922

Other Study ID Numbers:

CANOE

First Posted:

Jul 1, 2005

Last Update Posted:

May 24, 2012

Last Verified:

May 1, 2012

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Impaired glucose Tolerance

Additional relevant MeSH terms:

Glucose Intolerance

Metformin

Rosiglitazone

Study Results

No Results Posted as of May 24, 2012