Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Multicenter Study to Assess Safety & Efficacy of BGP-15 Administered Orally 1 or 2 Times Daily With Metformin & Sulfonylurea or Metformin in T2 Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 196
- 试验地点
- 29
- 主要终点
- Change from Baseline in Glycosylated Hemoglobin at Week 13
研究概览
简要总结
This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose, multicenter study with 5 treatment arms and 1 placebo arm. Patients should be treated with both metformin and SU or metformin alone. Patients will be randomized to 100,100 + 100, 200, 200 + 200, and 400 mg/day or placebo, as an add-on to their current treatment. The study consists of 2 periods:
- A 14-day screening period for ascertaining the inclusion/exclusion criteria; and,
- A 13-week treatment period with different doses of BGP-15 or placebo as an add-on therapy to metformin and SU treatment or metformin treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
6. BGP-15
400 mg BGP-15 + Placebo
干预措施: BGP-15 400 mg QD (Drug)
5. BGP-15
200 mg BGP-15 BID
干预措施: BGP-15 200 mg BID (Drug)
4. BGP-15
200 mg BGP-15 + Placebo
干预措施: BGP-15 200 mg QD (Drug)
3. BGP-15
Two 50 mg BGP-15 capsules by mouth in the morning; and two 50 mg BGP-15 capsules by mouth in the evening
干预措施: BGP-15 100 mg BID (Drug)
2. BGP-15
100 mg BGP-15 + placebo
干预措施: BGP-15 100 mg QD (Drug)
1. Placebo
Placebo BID
干预措施: Placebo BID (Drug)
结局指标
主要结局
Change from Baseline in Glycosylated Hemoglobin at Week 13
时间窗: Baseline and Week 13
次要结局
- Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13(Baseline and Weeks 4, 8, and 13)
- Change from Baseline in Plasma Glucose at Week 13(Baseline and Week 13)
- Cardiovascular and metabolic biomarkers at Baseline and 13 weeks(Baseline and Week 13)