Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Older adults, Incretins, Hyperglycemia, Insulin resistance
Brief summary
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.
Detailed description
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.
Interventions
All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.
Sponsors
Merck Frosst Canada Ltd.
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes managed by diet or metformin only * A1c \< 8.5%
Exclusion criteria
* treated with insulin or oral agents other than metformin in the past 6 months * evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy * type 1 diabetes or a history suggestive of a secondary causes of diabetes * A1c ≥ 8.5% * participated in another clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes | — |
Countries
Canada
Outcome results
None listed