Sitagliptin in the Elderly

Type 2 Diabetes Clinical Trial

Official title:

Sitagliptin in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451113
• Other study ID #: H06-03067
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2007
• Last updated: January 16, 2018
• Start date: November 2006
• Est. completion date: November 2012

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	University of British Columbia Gerontology & Diabetes Research Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Merck Frosst Canada Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes