Sitagliptin in the Elderly

University of British Columbia

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Sitagliptin 100 mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00451113

H06-03067

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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