A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Two-center, Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
研究概览
简要总结
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
详细描述
This is a double-blind, randomized, placebo-controlled, multiple-dose, two-center, safety and efficacy study of co-administration of tesofensine/metoprolol treatment in subjects with T2DM. Study medication will be administered for ninety (90) days (+2 days after the final assessments with half-dose of metoprolol). Following all baseline assessments, eligible subjects will be randomly assigned to one of the two arms (1:1).
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
- •Males and females
- •Confirmed diagnosis of T2DM
- •18-70 years of age
- •HbA1c ≥7.0%
排除标准
- •Hypersensitivity to tesofensine/metoprolol
- •Heart failure class II or greater according to the New York Heart Association (NYHA) or decompensated heart failure
- •History of myocardial infarction or stroke within 12 months prior to enrolment
- •History of coronary revascularisation or angioplasty in the last 12 months prior to enrolment
- •Patients reporting angina in the last 6 months prior to enrolment
- •Treatment with insulin and/or other injectable anti-diabetic medications, or TZDs
- •Any clinically significant cardiac arrhythmia
研究组 & 干预措施
Tesofensine/Metoprolol
Oral tablets Tesofensine/Metoprolol
干预措施: Tesofensine/Metoprolol (Drug)
Placebo
Placebo tablets matching oral Tesofensine/Metoprolol
干预措施: Placebo (Drug)
结局指标
主要结局
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
时间窗: Baseline to Day 90
24-hour heart rate monitoring was based on telemetry measurements at baseline (Day -1 to 1, V2) and at the end of treatment (Day 90 to 91, V10). The heart rate was measured every minute and the mean was recorded for every hour.
次要结局
- Change From Baseline to End of Treatment in HbA1c(Baseline to Day 90)
- Change From Baseline to End of Treatment in Body Weight(Baseline to Day 90)