JPRN-jRCT2080223790已完成3 期
A phase III, double-blind, insulin-combination therapy study of imeglimin (TIMES 3)
POXEL S.A./ CMIC Co., Ltd.0 个研究点目标入组 215 人开始时间: 2018年1月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
研究概览
简要总结
Imeglimin significantly improved HbA1c in Japanese patients with insufficiently controlled type 2 diabetes by insulin and had a similar safety profile to placebo. The efficacy of imeglimin on top of insulin was sustained for 52 weeks. Imeglimin represents a potential new treatment option for this population as add-on to insulin therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main inclusion criteria:
- •1) Insulin treated patients with type 2 diabetes mellitus, diagnosed for at least 12 weeks
- •2) HbA1c >=7.5% and < 11.0%
- •5) Body Mass Index (BMI) >= 18.5
排除标准
- •Main exclusion criteria:
- •1) Patients with type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- •2) History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- •3) Cardiovascular or cerebrovascular disease within 24 weeks (myocardial infarction, stroke, unstable angina etc.)
- •4) Uncontrolled high blood pressure
- •5) Severe impairment of hepatic function
研究者
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