Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- AUC of insulin
研究概览
简要总结
- Explore pharmacodynamics
- glucose
- insulin
- C-peptide
- glucagon
- intact GLP-1
- DPP-4 activity
- CGMS (continuous glucose monitoring system)
- Assess Safety
- adverse events
- clinical laboratory test
- physical examination
详细描述
Pharmacodynamic assessment
- CGMS data is obtained from day 1 to day 3 (48 hours)
- PD is measured before (day 1) and after drug administration (day 2)
- AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
- MAGE (mean amplitude of glycemic excursion) from CGMS data
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with type 2 diabetes mellitus
- •6.5% ≤ HbA1c < 9.0%
- •Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
- •Stopped treatment of other anti-diabetic agents for more than 12 weeks
- •16 kg/m2 ≤ body mass index < 30 kg/m2
排除标准
- •Fasting glucose ≥ 200 mg/dL
- •Required insulin therapy
- •Patients with neuropathy, retinopathy or renopathy
- •Contraindicated for mitiglinide or sitagliptin
研究组 & 干预措施
Sitagliptin
干预措施: Sitagliptin (Drug)
Mitiglinide
干预措施: Mitiglinide (Drug)
Sitagliptin + Mitiglinide
干预措施: Sitagliptin, Mitiglinide (Drug)
结局指标
主要结局
AUC of insulin
时间窗: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC (area under the curve) of plasma glucose
时间窗: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of glucagon
时间窗: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of intact GLP-1
时间窗: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
MAGE
时间窗: day 1 and day 2 of each period
Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of C-peptide
时间窗: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
AUC of DPP-4 activity
时间窗: day 1 and day 2 of each period
Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups
次要结局
未报告次要终点