Clinical trial NCT00451113: Sitagliptin in the Elderly
Official title: Sitagliptin in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Older adults
Incretins
Hyperglycemia
Insulin resistance
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2007-03-23
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Gerontology & Diabetes Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Graydon Meneilly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stafford S, Elahi D, Meneilly GS. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin in older adults with type 2 diabetes mellitus. J Am Geriatr Soc. 2011 Jun;59(6):1148-9. doi: 10.1111/j.1532-5415.2011.03438.x. No abstract available.