NCT02081118已完成2 期
A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2014年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Change in baseline in glycosylated haemoglobin (HbA1c) at 16 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 month 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
- •Taking a stable dose of 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 at screening
- •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 acute or chronic pancreatitis
- •A history of alcohol or drug abuse or drug addiction
研究组 & 干预措施
HM11260C (16 mg)
Experimental
Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks
干预措施: HM11260C (Drug)
HM11260C (8 mg)
Experimental
Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks
干预措施: HM11260C (Drug)
HM11260C (12 mg)
Experimental
Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks
干预措施: HM11260C (Drug)
Placebo
Placebo Comparator
Monthly administration of placebo by subcutaneous injection for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks
时间窗: Up to day 155
次要结局
- Body weight(Up to day 155)
- Fasting insulin(Up to day 155)
- C-peptide(Up to day 155)
- Glucagon(Up to day 155)
- 7-point glucose profile(Up to day 155)
- Glycated albumin(Up to day 155)
- Serum lipid profile(Up to day 155)
- Fasting plasma glucose levels (FPG)(Up to day 155)
研究者
研究点 (1)
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