The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Glucagon Counterregulation to Hypoglycemia
研究概览
简要总结
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM
详细描述
The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent has been given.
- •Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months)
- •Age >65 years.
- •HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit
- •Ability to complete the study
排除标准
- •A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- •Type 2 diabetes, positive GAD antibodies
- •eGFR <60 ml/min
- •Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- •Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
- •Liver disease such as cirrhosis or chronic active hepatitis
- •History of coronary heart disease or heart failure class III or IV
- •Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
- •Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit
- •Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
研究组 & 干预措施
Sitagliptin first, then placebo
Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks
干预措施: Sitagliptin (Drug)
Placebo first, then sitagliptin
Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Glucagon Counterregulation to Hypoglycemia
时间窗: Four weeks treatment
Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo
次要结局
未报告次要终点