Sitagliptin in the Elderly

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia Gerontology & Diabetes Research Centre

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin 100 mg

Drug

All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.

Other names: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)

Primary outcomes

Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

Merck Frosst Canada Ltd.

Registry information

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Mar 23, 2007
Registry last updated: Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed