A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
Primary Purpose
Impaired Glucose Tolerance, Diabetes
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID
Sponsored by
About this trial
This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring Diabetes, Prevention., Rosiglitazone, Metformin, Lifestyle, Impaired glucose Tolerance
Eligibility 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
Sites / Locations
- UWO Research Park
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
A
Arm Description
Avandamet [ Rosuglitazone 2 and Metformin 500]
Outcomes
Primary Outcome Measures
Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels
Secondary Outcome Measures
Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually
Full Information
NCT ID
NCT00116922
First Posted
June 30, 2005
Last Updated
May 22, 2012
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators
University of Western Ontario, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00116922
Brief Title
A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
Official Title
CAnadian Normoglycemia Outcomes Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators
University of Western Ontario, Canada
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Diabetes
Keywords
Diabetes, Prevention., Rosiglitazone, Metformin, Lifestyle, Impaired glucose Tolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Avandamet [ Rosuglitazone 2 and Metformin 500]
Intervention Type
Drug
Intervention Name(s)
Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID
Other Intervention Name(s)
Avandamet
Intervention Description
[Rosiglitazone 2mg/ Metformin 500mg] twice daily
Primary Outcome Measure Information:
Title
Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels
Time Frame
Dec 2009
Secondary Outcome Measure Information:
Title
Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually
Time Frame
Dec2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Zinman, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stewart Harris, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
UWO Research Park
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 4X8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
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