NCT00836940Unknown2 期
A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
Glenmark Pharmaceuticals Europe Ltd. (R&D)1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
研究概览
简要总结
The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.
The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.
This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥30 years of age
- •At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
- •Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
- •Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
- •Has an HbA1c value at screening between 6.5% and 10%
排除标准
- •Has type 1 diabetes
- •Is a female who is lactating or is pregnant
- •Has a history of acute metabolic diabetic complications
- •Has clinically significant disease other than type 2 diabetes mellitus
研究组 & 干预措施
1
Placebo Comparator
干预措施: GRC 8200 (Drug)
2
Experimental
GRC 8200-25mg OD
干预措施: GRC 8200 (Drug)
3
Experimental
GRC 8200-50mg OD
干预措施: GRC 8200 (Drug)
4
Experimental
GRC 8200-50mg BD
干预措施: GRC 8200 (Drug)
5
Experimental
GRC 8200-100mg OD
干预措施: GRC 8200 (Drug)
结局指标
主要结局
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
时间窗: 12 weeks
次要结局
- Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment(4 and 8 weeks)
- Fasting plasma glucose and fasting serum insulin(12 weeks)
- Plasma glucose 2 hours post glucose challenge (OGTT)(12 weeks)
- HOMA-IR(12 weeks)
- HOMA-B(12 weeks)
- Change in serum lipids(12 weeks)
- Body weight(12 weeks)
- Waist circumference(12 weeks)
研究者
研究点 (1)
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