A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 551
- 试验地点
- 108
- 主要终点
- Primary Endpoint: mean change in HbA1c
研究概览
简要总结
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.
详细描述
This Phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. 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 modifications, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.
Patients who complete the double-blind treatment phase will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for 28 weeks.
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
- •Received a stable dose of metformin monotherapy for at least 8 weeks prior to screening
- •If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
- •Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization)
- •Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
- •Have a body mass index ≥19.0 kg/m^2 to ≤35.0 kg/m^2
排除标准
- •Have type 1 diabetes
- •Have had any acute diabetic complications within 12 months prior to screening
- •Have had any Grade 3 hypoglycemic event within 12 months prior to screening
- •Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
- •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 12 weeks prior to screening
- •Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
- •Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization
- •Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
研究组 & 干预措施
HTD1801
Administered orally twice daily (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
Primary Endpoint: mean change in HbA1c
时间窗: 24 Weeks
Mean change in HbA1c from baseline to Week 24
次要结局
- DB Phase: proportion of patients achieving HbA1c <7.0%(24 Weeks)
- Double-blind (DB) Phase: mean change in fasting plasma glucose(24 Weeks)
- DB Phase: mean change in 2-hour postprandial glucose(24 Weeks)
- DB Phase: proportion of patients achieving HbA1c <6.5%(24 Weeks)
- DB Phase: mean change in insulin sensitivity (HOMA-IR)(24 Weeks)
- DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C)(24 Weeks)