NCT02059564Unknown1 期
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- PK profile of acetaminophen
研究概览
简要总结
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
详细描述
Primary Objective
- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying
Secondary Objectives
- evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test
- evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide
- evaluate safety and tolerability of different doses of HM11260C and liraglutide
- evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
- •History of type 2 diabetes
- •Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
- •Use of approved methods of contraception
- •Ability to provide written informed consent
排除标准
- •Type 1 diabetes
- •Significant acute diabetic proliferative retinopathy or severe neuropathy
- •Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
- •Pregnant or lactating women
- •Participation in an investigational study within 30 days prior to randomization
- •History of any major surgery within 6 months prior to Screening
- •History of any serious adverse reaction or hypersensitivity to any of the product components.
- •History of renal disease or significantly abnormal kidney function tests at Screening
- •History of hepatic disease or significantly abnormal liver function tests
- •History of any active infection within 30 days prior to Randomization
- •Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- •Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
- •Donation or loss of >500 mL of blood or blood product within 56 days of Randomization
研究组 & 干预措施
Cohort A
Experimental
The weekly treatment of the 6 mg HM11260C or placebo will be maintained
干预措施: HM11260C (Drug)
Cohort A
Experimental
The weekly treatment of the 6 mg HM11260C or placebo will be maintained
干预措施: Placebo (Drug)
Cohort B
Experimental
The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
干预措施: HM11260C (Drug)
Cohort B
Experimental
The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
干预措施: Placebo (Drug)
Cohort C
Experimental
The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg
干预措施: Victoza (Drug)
结局指标
主要结局
PK profile of acetaminophen
时间窗: 13 weeks
Cmax, AUC at 13 weeks
次要结局
- Glucose metabolism(13 weeks)
- Safety and tolerability(18 weeks)
研究者
研究点 (1)
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