Sitagliptin in the Elderly
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes managed by diet or metformin only
- •A1c < 8.5%
排除标准
- •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
结局指标
主要结局
Safety and efficacy of Sitagliptin in an elderly population with type 2 diabetes
次要结局
未报告次要终点
研究者
Graydon Meneilly
Principal Investigator
University of British Columbia