NCT04556851已完成3 期
A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes
Sichuan Haisco Pharmaceutical Group Co., Ltd2 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2020年9月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 476
- 试验地点
- 2
- 主要终点
- HbA1c change from baseline at week 24
研究概览
简要总结
The purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.
详细描述
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653 and matching placebo, or placebo only. During the open-label period, all participants will receive 25 mg dose of HSK7653.
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
- •Age ≥ 18 and ≤ 75 years, Male and female patients;
- •Type 2 diabetes mellitus;
- •Control the blood glucose level only with diet and exercise in last 8 weeks;
- •Did not receive regular long-term medication of oral hypoglycemic drugs or insulin within 1 year prior to informed consent;
- •HbA1c in the range of ≥7.5 to ≤11.0% at screening;
- •FPG < 15 mmol/L at screening;
- •BMI (Body Mass Index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening.
排除标准
- •Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
- •History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
- •Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy 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 Dipeptidyl-Peptidase 4 (DPP-4) inhibitor, Glucose-dependent insulinotropic polypeptide (GIP) or Glucagon-like peptide-1 (GLP-1) receptor agonist;
- •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;
- •Contraindication for metformin;
- •Other protocol-defined inclusion/exclusion criteria.
研究组 & 干预措施
HSK7653 10 mg
Experimental
干预措施: HSK7653 10 mg Q2W (Drug)
HSK7653 25 mg
Experimental
干预措施: HSK7653 25 mg Q2W (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c change from baseline at week 24
时间窗: Baseline and week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
次要结局
- The Safety of HSK7653 at Week 24 and Week 52(Baseline, week 24 and week 52)
- Percentage of Patients With HbA1c <6.5%(Baseline, week 24 and week 52)
- Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52(Baseline, week 24 and week 52)
- Pancreatic β-cell function Change (Calculated by HOMA-β ) From Baseline at Week 24 and Week 52(Baseline, week 24 and week 52)
- Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia(Baseline, week 24 and week 52)
- Percentage of Patients With HbA1c <7.0%(Baseline, week 24 and week 52)
- FPG Change From Baseline at Week 24 and Week 52(Baseline, week 24 and week 52)
- 2h-PPG Change From Baseline at Week 24 and Week 52(Baseline, week 24 and week 52)
- Weight Change From Baseline at Week 24 and Week 52(Baseline, week 24 and week 52)
- Fasting C-peptide Change From Baseline at Week 24 and Week 52(Baseline, week 24 and week 52)
研究者
研究点 (2)
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