NCT06059326已完成2 期
A Multicenter, Randomized, Double-blind, Placebo Control, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in Type 2 Diabetes Mellitus Patients
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年1月22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
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 Age ≤70 years
- •T2DM patients,
- •Control the blood glucose level only with diet and exercise in last 3 months;
- •BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
- •HbA1c ≥7.0% and HbA1c <10.0%
- •FPG <13.9 mmol/L
排除标准
- •Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history;
- •History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis);
- •History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening);
- •Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months;
- •Three or more episodes of hypoglycemia occurred in the six months prior to screening;
- •History of hyperthyroidism within 6 months before screening;
- •Severe cardiovascular disease. ;
- •Medical conditions that may significantly affect drug absorption, distribution, metabolism, and excretion within 2 weeks prior to screening;
- •Liver function tests abnormal;
- •Moderate or severe renal impairment;
- •Medical history or clinical evidence of pancreatic injury or pancreatitis, or abnormalities in lipase and amylase judged by investigators to be clinically significant;
- •Patients with a history of hypertension who regularly take antihypertensive therapy for over 4 weeks still have poor control, SBP > 160 mmHg and (or) DBP > 100 mmHg;
- •Patients with uncontrolled hyperlipidemia.
研究组 & 干预措施
HSK7653 10 mg
Experimental
干预措施: HSK7653 10 mg (Drug)
HSK7653 25 mg
Experimental
干预措施: HSK7653 25 mg (Drug)
HSK7653 50 mg
Experimental
干预措施: HSK7653 50 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
次要结局
- Peak plasma concentration (Cmax) of HSK7653(Day 1 to Day 43)
- Area under the plasma concentration versus time curve (AUC) of HSK7653(Day 1 to Day 43)
- Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate(Day 1 to Day 84)
- Change from baseline in GLP-1(Day 1 to Day 84)
- Change from baseline of fasting plasma glucose(Day 1 to Day 84)
- Change from baseline of HbA1c(Day 1 to Day 84)
- Half-life (t1/2) of HSK7653(Day 1 to Day 43)
研究者
研究点 (1)
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