A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks
研究概览
简要总结
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages eligible for study : 18 years to 74 years
- •Genders eligible for study : Male and Female
- •Diagnosed with T2DM
- •Received diet and exercise therapy with or without metformin monotherapy
- •HbA1c levels of between ≥ 7.0% and ≤ 10.0%
- •Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
- •Written informed consent must be obtained
排除标准
- •Pregnant or nursing (lactating) women
- •Diagnosis of type 1 diabetes mellitus
- •Uncontrolled diabetes defined as a FPG level of > 240 mg/dL
- •A significant change in body weight in the 3 months before screening
- •Any history of GI intolerance
- •Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
- •Known history of chronic pancreatitis
- •A history of alcohol or drug abuse or drug addiction
研究组 & 干预措施
Placebo
Weekly administration of placebo by subcutaneous injection for 12 weeks
干预措施: Placebo (Drug)
HM11260C (0.3 mg)
Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks
干预措施: HM11260C (Drug)
HM11260C (1 mg)
Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks
干预措施: HM11260C (Drug)
HM11260C (2 mg)
Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks
干预措施: HM11260C (Drug)
HM11260C (3 mg)
Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks
干预措施: HM11260C (Drug)
HM11260C (4 mg)
Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks
干预措施: HM11260C (Drug)
Liraglutide
Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.
干预措施: liraglutide (Drug)
结局指标
主要结局
Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks
时间窗: Up to 127 days
次要结局
- Fasting plasma glucose levels (FPG)(Up to 127 days)
- Serum lipid profile(Up to day 127)
- Body weight(Up to day 127)
- 7-point glucose profile(Up to day 127)
- Other glycaemic control parameters(Up to day 127)
- Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%(Up to 127 days)