Sitagliptin in the Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sitagliptin in the Elderly

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin 100 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sitagliptin 100 mg|All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Older adults, Incretins, Hyperglycemia, Insulin resistance