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Sitagliptin in the Elderly

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sitagliptin 100 mg
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Older adults, Incretins, Hyperglycemia, Insulin resistance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of British Columbia Gerontology & Diabetes Research Centre

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 21, 2007
Last Updated
January 16, 2018
Sponsor
University of British Columbia
Collaborators
Merck Frosst Canada Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00451113
Brief Title
Sitagliptin in the Elderly
Official Title
Sitagliptin in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Merck Frosst Canada Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Older adults, Incretins, Hyperglycemia, Insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100 mg
Other Intervention Name(s)
Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
Intervention Description
All subjects will receive a single 100 mg dose of sitagliptin and a placebo. Which they are given first is determined randomly.
Primary Outcome Measure Information:
Title
Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graydon Meneilly, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia Gerontology & Diabetes Research Centre
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21668924
Citation
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.
Results Reference
derived

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Sitagliptin in the Elderly

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