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| Sponsors and Collaborators: |
University of British Columbia Merck Frosst Canada Ltd. |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00451113 |
Purpose
Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will have diabetes. Unfortunately, currently available medications are often not as effective or not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent called incretins. Incretins have many potential advantages for the treatment of diabetes in the elderly. They stimulate insulin secretion, which is impaired in all older people with diabetes. The incidence of hypoglycemia with currently available medications increases with age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many current medications used to manage diabetes result in weight gain in the elderly. They improve insulin action, and insulin resistance is a major problem in older people with diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Sitagliptin 100 mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Sitagliptin in the Elderly |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
To date, no clinical trials have been conducted specifically in the elderly, but the data noted above from our laboratory would imply that inhibitors of this enzyme could be more effective in the elderly patient population. In addition, we have convincingly demonstrated that diabetes in the elderly is metabolically distinct from diabetes in middle aged patients (1). Thus, it is clear further studies are warranted to determine the effectiveness of drugs in this class in elderly patients with diabetes. We propose a series of studies with your DP4 inhibitor sitaglipitin to determine its efficacy and safety in an elderly patient population with diabetes.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Chris Lockhart | 604-875-4111 ext 68535 | lockhart@interchange.ubc.ca |
| Canada, British Columbia | |
| University of British Columbia Gerontology & Diabetes Research Centre | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Chris Lockhart 604-875-4111 ext 68535 lockhart@interchange.ubc.ca | |
| Principal Investigator: Graydon Meneilly, MD | |
| Principal Investigator: | Graydon Meneilly, MD | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Graydon Meneilly ) |
| Study ID Numbers: | H06-03067 |
| Study First Received: | March 21, 2007 |
| Last Updated: | September 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00451113 |
| Health Authority: | Canada: Health Canada |
|
Type 2 diabetes Older adults Incretins Hyperglycemia Insulin resistance |
|
Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin Sitagliptin |
|
Dipeptidyl-Peptidase IV Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |
