Sitagliptin in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451113
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : January 18, 2018
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Graydon Meneilly, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin 100 mg Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sitagliptin in the Elderly
Study Start Date : November 2006
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.
    Other Names:
    • Januvia
    • MK-0431
    • Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)

Primary Outcome Measures :
  1. Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451113

Canada, British Columbia
University of British Columbia Gerontology & Diabetes Research Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Merck Frosst Canada Ltd.
Principal Investigator: Graydon Meneilly, MD University of British Columbia

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Graydon Meneilly, Principal Investigator, University of British Columbia Identifier: NCT00451113     History of Changes
Other Study ID Numbers: H06-03067
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Graydon Meneilly, University of British Columbia:
Type 2 diabetes
Older adults
Insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action