A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
研究概览
简要总结
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has type 2 diabetes mellitus
- •Between the ages of 18 and 70
排除标准
- •Patient has a history of type 1 diabetes mellitus or ketoacidosis.
- •Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
- •Patient has had surgery within 30 days of starting the study or has planned major surgery during the study
研究组 & 干预措施
MK-0941
干预措施: MK-0941 (Drug)
MK-0941
干预措施: Metformin (Drug)
Glimepiride
干预措施: Glimepiride (Drug)
Glimepiride
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
时间窗: Baseline and Week 6
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
时间窗: Baseline to Week 6
Hypoglycemic episodes are defined as either a fingerstick glucose measurement of ≤70 mg/dL \[3.9 mmol/L\] with or without symptoms or symptomatic hypoglycemia.
次要结局
未报告次要终点