NCT04727580已完成2 期
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Clinical Trial to Study the Efficacy and Safety of HSK7653 in Chinese Patients with Impaired Glucose Tolerance
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2021年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
研究概览
简要总结
This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Impaired glucose tolerance;
- •BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;
排除标准
- •History of diabetes mellitus;
- •History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
- •Current uncontrolled hypertension, serious nephropathy prior to informed consent;
- •Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;
- •Serious gastrointestinal disease within 2 weeks prior to informed consent;
- •Serious infection, trauma, and surgery within 3 months prior to informed consent;
- •History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor;
- •Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
- •Hemoglobin (HGB) < 10.0 g/dL(100 g/L);
- •Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
- •Active infectious diseases;
- •Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
- •Women who are nursing or pregnant, or subjects with birth plans;
- •Other protocol-defined inclusion/exclusion criteria.
研究组 & 干预措施
HSK7653 10 mg
Experimental
干预措施: HSK7653 10mg Q2W (Drug)
HSK7653 25 mg
Experimental
干预措施: HSK7653 25mg Q2W (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
时间窗: Baseline and Week 12
Plasma glucose AUC 0-3 hours for MTT was measured at Baseline (Week 0) and at Week 12. After fasting for ≥8 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes. At Week 12, participants received study drug or placebo 50 minutes prior to consuming a standard meal.
次要结局
- Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12(Baseline and Week 12)
- Change From Baseline in Fasting Insulin at Week 12(Baseline and Week 12)
- Change From Baseline in HOMA-β at Week 12(Baseline and Week 12)
- Change From Baseline in Fasting C-peptide at Week 12(Baseline and Week 12)
- Change From Baseline in Fasting Glucose at Week 12(Baseline and Week 12)
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12(Baseline and Week 12)
- Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12(Baseline and Week 12)
- Change From Baseline in HOMA-IS at Week 12(Baseline and Week 12)
- Incidence of Treatment-Emergent Adverse Events(Baseline and Week 12)
- Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10(Baseline and Week 10)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
The Trial of SHR6508 in Secondary HyperparathyroidismSecondary HyperparathyroidismNCT06434961Shanghai Hengrui Pharmaceutical Co., Ltd.498
尚未招募
1 期
JSKN033 in Chinese Subjects with Advanced Malignant TumorsAdvanced Malignant TumorsNCT06770881Jiangsu Alphamab Biopharmaceuticals Co., Ltd430
已完成
2 期
A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.Chronic PeriodontitisNCT02585596Yuhan Corporation275
进行中（未招募）
2 期
A Study of SHR6508 in Secondary HyperparathyroidismSecondary HyperparathyroidismNCT05663411Shanghai Hengrui Pharmaceutical Co., Ltd.75
已完成
2 期
A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in PatientsColonoscopyNCT03773042Sichuan Haisco Pharmaceutical Group Co., Ltd64