A Lifestyle and Combination Medication Therapy Diabetes Prevention Study

NCT00116922 | Completed Phase 3 DMC

• 1 other identifier: CANOE
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 2

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.

Conditions

Impaired Glucose Tolerance; Diabetes

Keywords

Diabetes; Prevention.; Rosiglitazone; Metformin; Lifestyle; Impaired glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels

  Dec 2009

Secondary Outcomes (1)

• Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually

  Dec2009

Study Arms (1)

A

ACTIVE COMPARATOR

Avandamet \[ Rosuglitazone 2 and Metformin 500\]

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

Interventions

Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID DRUG

\[Rosiglitazone 2mg/ Metformin 500mg\] twice daily

Also known as: Avandamet

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents of Ontario
• Age 18-75
• IGT on OGTT

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead
• University of Western Ontario, Canada: collaborator

Study Sites (2)

UWO Research Park

London, Ontario, N6G 4X8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus

Interventions

rosiglitazone-metformin combination; Rosiglitazone; BID protein, human

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bernard Zinman, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Stewart Harris, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 1, 2005
• Study Start: June 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

CA (2)