Sitagliptin in the Elderly

This study has been completed.
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00451113
First received: March 21, 2007
Last updated: March 14, 2014
Last verified: March 2014

March 21, 2007
March 14, 2014
November 2006
November 2012   (final data collection date for primary outcome measure)
Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Safety and efficacy of Sitigliptin in an elderly population with type 2 diabetes
Complete list of historical versions of study NCT00451113 on ClinicalTrials.gov Archive Site
Not Provided
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Sitagliptin in the Elderly
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes
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)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00451113
H06-03067
No
University of British Columbia
University of British Columbia
Merck Frosst Canada Ltd.
Principal Investigator: Graydon Meneilly, MD University of British Columbia
University of British Columbia
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP