A Multi-center, Randomized, Double-blind, Placebo-controlled, 12-week Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Population PK of HMS5552 in Type 2 Diabetic Adult Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- After 12-week Treatment, the Change From Baseline in HbA1c
研究概览
简要总结
This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.
详细描述
Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female, 40~75 years old
- •T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
- •HbA1c 7.5~10.5% at screening and pre-randomization
- •Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
- •BMI: 19~30kg/m^2 & TG<5.5mmol/L
排除标准
- •T1D，secondary DM, pre-DM
- •kidney diseases or eGFR MDRD<60ml/min/1.73m^2
- •unstable CVDs
- •liver diseases
- •mental or CNS diseases
研究组 & 干预措施
HMS5552 dose 1
75mgQD oral administration
干预措施: HMS5552 (Drug)
HMS5552 dose 2
100mgQD oral administration
干预措施: HMS5552 (Drug)
HMS5552 dose 3
50mgBID oral administration
干预措施: HMS5552 (Drug)
HMS5552 dose 4
75mgBID oral administration
干预措施: HMS5552 (Drug)
Placebo
Placebo, BID/QD oral administration
干预措施: Placebo (Other)
结局指标
主要结局
After 12-week Treatment, the Change From Baseline in HbA1c
时间窗: Baseline and 12 weeks
Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module.
次要结局
- Change From Baseline in 2hPPG(Baseline and 12 weeks)
- Change From Baseline in FPG(Baseline and 12 weeks)