The Effect of Neprilysin on Plasma Concentrations of Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Blood Glucose
研究概览
简要总结
Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans with type 2 diabetes is unknown.
We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or placebo, to patients with type 2 diabetes during a standardized meal and measured plasma concentrations of GLP-1
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •Oral Antidiabetics Medicine Only
- •Body Mass Index of 25-35
- •Type 2 Diabetes
排除标准
- •acute diseases within the two weeks
- •chronic diseases
- •alcoholism, drug addiction or recent weight loss
- •blood donation within the last 3 months
研究组 & 干预措施
Placebo
Participants are subjected to a standardized meal
干预措施: Placebo (Drug)
Entrestro
194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal
干预措施: Entresto (Drug)
Sitagliptin
200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
干预措施: Sitagliptin (Drug)
Entrestro + sitagliptin
194 mg sacubitril / 206 mg valstartan (entresto) + 200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
干预措施: Entresto (Drug)
Entrestro + sitagliptin
194 mg sacubitril / 206 mg valstartan (entresto) + 200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
干预措施: Sitagliptin (Drug)
Valsartan
206mg valsartan as one single dose followed by a standardized meal
干预措施: Valsartan (Drug)
结局指标
主要结局
Blood Glucose
时间窗: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of glucose
次要结局
- Plasma Concentrations of Glucagon(3 hours after treatment ( during the subsequent standardized meal))
- Plasma Concentrations of Insulin(3 hours after treatment ( during the subsequent standardized meal))
- Plasma Concentrations of GLP-1(3 hours after treatment ( during the subsequent standardized meal))
- Plasma Concentrations of GIP(3 hours after treatment ( during the subsequent standardized meal))
- Plasma Concentrations of C-Peptide(3 hours after treatment ( during the subsequent standardized meal))
- Plasma Concentrations of Amino Acids(3 hours after treatment ( during the subsequent standardized meal))
研究者
Nicolai Jacob Wewer Albrechtsen
Resident
University of Copenhagen