Sitagliptin in the Elderly

NCT00451113 | Completed Phase 2

• 1 other identifier: H06-03067
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Older adults; Incretins; Hyperglycemia; Insulin resistance

Outcome Measures

Primary Outcomes (1)

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

Interventions

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.

Also known as: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• type 2 diabetes managed by diet or metformin only
• A1c \< 8.5%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Merck Frosst Canada Ltd.: collaborator

Study Sites (1)

University of British Columbia Gerontology & Diabetes Research Centre

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 21668924 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Insulin Resistance

Interventions

Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Graydon Meneilly, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 23, 2007
• Study Start: November 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

CA (1)