NCT06901648已完成2 期
Efficacy and Safety of HS-20094, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients With Type 2 Diabetes: a Randomized, Placebo-controlled and Active Comparator-controlled Phase 2 Trial
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2024年2月6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
- 275
- 试验地点
- 1
- 主要终点
- The change of HbA1c in the patients
研究概览
简要总结
This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.
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
- •Male or female patients 18 to 75 years of age, inclusive
- •Patients were diagnosed with T2DM for at least 3 months before screening.
- •Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening
- •Body mass index (BMI）≥ 22 kg/m2.
排除标准
- •Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
- •Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening
- •A history of grade 3 hypoglycemia (hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery) within 6 months before screening
- •Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
- •Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)
- •Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)
研究组 & 干预措施
HS-20094 5mg
Experimental
干预措施: HS-20094 (Drug)
HS-20094 10mg
Experimental
干预措施: HS-20094 (Drug)
HS-20094 15mg
Experimental
干预措施: HS-20094 (Drug)
Dulaglutide 1.5mg
Active Comparator
干预措施: Dulaglutide (Drug)
Placebo
Placebo Comparator
干预措施: Palcebo (Drug)
结局指标
主要结局
The change of HbA1c in the patients
时间窗: From baseline to week 32
次要结局
- The percentage of patients reaching the HbA1c target of ≤ 6.5%(From baseline to week 32)
- The percentage of patients reaching the HbA1c target of<7.0%(From baseline to week 32)
- The change in fasting blood glucose(From baseline to week 32)
- The change in C peptide(From baseline to week 32)
- The change of fasting insulin in the patients(From baseline to week 32)
- The change in body weight(From baseline to week 32)
- The percentage of patients with 5% or greater body weight loss(From baseline to week 32)
研究者
研究点 (1)
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