A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled (Dapagliflozin), Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 90
- 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 dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.
详细描述
This Phase 3 randomized, double-blind, active-controlled, parallel-group study will evaluate the efficacy and safety of HTD1801 compared to dapagliflozin after 24 weeks of treatment. All patients will remain on a stable dose of metformin throughout the study.
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 then be randomized 1:1 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD.
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
- •Have 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 and ≤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
- •Have a history of refractory or recurrent urinary tract infections or genital infections
研究组 & 干预措施
HTD1801
Administered orally twice daily (BID)
干预措施: HTD1801 (Drug)
Dapagliflozin
Administered orally once daily (QD)
干预措施: Dapagliflozin (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
- Mean Change in Fasting Plasma Glucose(24 Weeks)
- Mean Change in 2-Hour Postprandial Glucose(24 Weeks)
- Proportion of Patients Achieving HbA1c <7.0%(24 Weeks)
- Proportion of Patients Achieving HbA1c <6.5%(24 Weeks)
- Mean Change in Insulin Sensitivity (HOMA-IR)(24 Weeks)
- Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)(24 Weeks)