A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Diet and Exercise
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 15
- 主要终点
- Mean change in HbA1c
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.
详细描述
This Phase 2 randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of HTD1801 compared to placebo after 12-weeks of treatment.
To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will be randomized 1:1:1 to receive HTD1801 500 mg twice daily (BID), HTD1801 1000 mg BID, or placebo BID.
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
- •Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria
- •Have followed dietary and exercise interventions for at least 8 weeks prior to screening
- •Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
- •Have fasting plasma glucose <13.9 mmol/L (screening and pre-randomization)
- •Have a body mass index ≥18 kg/m^2 to ≤40 kg/m^2
排除标准
- •Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.)
- •Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
- •Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening
- •Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening
- •Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening
- •Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
- •Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening
- •Have used any glucose-modifying medications within 8 weeks prior to screening
- •Have had weight gain or loss ≥5% from screening to randomization
研究组 & 干预措施
HTD1801 500 mg
Administered orally twice daily (BID)
干预措施: HTD1801 (Drug)
HTD1801 1000 mg
Administered orally BID
干预措施: HTD1801 (Drug)
Placebo
Administered orally BID
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in HbA1c
时间窗: 12 Weeks
Mean change in HbA1c from baseline to Week 12
次要结局
- Mean change in postprandial glucose(12 Weeks)
- Mean change in fasting plasma glucose(12 Weeks)
- Proportion of patients achieving HbA1c <7.0%(12 Weeks)
- Proportion of patients achieving HbA1c <6.5%(12 Weeks)
- Mean change in low-density lipoprotein cholesterol (LDL-C)(12 Weeks)