A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
研究概览
简要总结
The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin 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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has Type 2 Diabetes Mellitus
排除标准
- •Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
- •Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
- •Participant has had surgery within 30 days of starting the study or has planned major surgery
研究组 & 干预措施
Placebo
Participants receiving placebo tablets three times daily plus insulin injection once daily
干预措施: Placebo (Drug)
Placebo
Participants receiving placebo tablets three times daily plus insulin injection once daily
干预措施: Insulin (Drug)
MK-0941
Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
干预措施: MK-0941 (Drug)
MK-0941
Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
干预措施: Insulin (Drug)
结局指标
主要结局
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
时间窗: From first dose of study drug (Week 0) to last dose of study drug (Week 20)
Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.
Change From Baseline in Hemoglobin A1c (HbA1c) Level
时间窗: Baseline (Day 1) and End of Treatment (Week 20)
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
次要结局
未报告次要终点