NCT07026968进行中（未招募）3 期
A Multicenter, Randomized, Double-blind, Parallel-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Triple Combination Therapy of Prusogliptin , Dapagliflozin and Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 815
- 试验地点
- 1
- 主要终点
- Mean change from baseline in HbA1c at Week 24
研究概览
简要总结
This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.
详细描述
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
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
- •Subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening;
- •Male or female, 18 years ≤ age ≤ 75 years;
- •Body Mass Index (BMI) ≥ 18.5 kg/m^2, and ≤40 kg/m^2;
- •Stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day;
- •The glycated hemoglobin must meet the following standards:During screening: 7.5% ≤ HbA1c ≤ 11.0% (local laboratory);Before random sampling: 7.0% ≤ HbA1c ≤ 10.5% (central laboratory);
- •Be able to understand and follow the test procedures, voluntarily participate in the test and sign the ICF.
排除标准
- •Type 1 diabetes or other special types of diabetes;
- •≥2 episodes of Grade 3 hypoglycemia within 6 months prior to screening, or any Grade 3 hypoglycemia occurring from screening to randomization;
- •≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization;
- •Severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening;
- •History of acute or chronic pancreatitis at screening or prior to randomization;
- •Inflammatory bowel disease, partial intestinal obstruction, or chronic intestinal diseases associated with malabsorption within 6 months prior to screening or prior to randomization;
- •Previous gastrointestinal surgeries that may cause malabsorption (excluding polypectomy and appendectomy), or chronic use of medications directly affecting gastrointestinal motility at screening or prior to randomization;
- •Any cardiovascular event within 6 months prior to screening or prior to randomization, including: decompensated heart failure (NYHA Class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long QT syndrome or prolonged QTcF interval (male >450 ms, female >470 ms); clinically significant arrhythmia requiring treatment and deemed unsuitable for trial participation by the investigator;
- •Hemorrhagic stroke or acute ischemic stroke within 6 months prior to screening or prior to randomization;
- •Acute gallbladder disease within 6 months prior to screening, or active gallbladder disease requiring treatment at screening/prior to randomization;
- •History of severe psychiatric disorders (e.g., depression, anxiety disorders), severe osteoporosis, or other medical conditions that may endanger participant safety as judged by the investigator;
- •Malignancy (except clinically cured basal cell carcinoma or carcinoma in situ) diagnosed or treated within 5 years prior to screening or prior to randomization;
- •Severe infection or trauma within 4 weeks prior to screening/prior to randomization; recurrent urinary tract infections or genital infections within 6 months prior to screening; or symptomatic urinary/genital infections at screening/prior to randomization;
- •Clinically significant hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome) or conditions causing hemolysis or erythrocyte instability (e.g., malaria) at screening/prior to randomization;
- •Pregnant or lactating women;
- •Other conditions deemed unsuitable for trial participation by the investigator.
研究组 & 干预措施
Prusogliptin, plus metformin XR
Active Comparator
干预措施: Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR (Drug)
Prusogliptin, Dapagliflozin(high dose), plus metformin XR
Experimental
干预措施: Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR (Drug)
Dapagliflozin(high dose), plus metformin XR
Active Comparator
干预措施: Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR (Drug)
Prusogliptin, Dapagliflozin(low dose), plus metformin XR
Experimental
干预措施: Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR (Drug)
Dapagliflozin(low dose), plus metformin XR
Active Comparator
干预措施: Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR (Drug)
结局指标
主要结局
Mean change from baseline in HbA1c at Week 24
时间窗: From baseline to week 24
次要结局
- Relative change from baseline in HbA1c at week 12(From baseline to week 12)
- Relative change from baseline in FPG at week 12 and week 24(From baseline to week 12 and week 24)
- Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24(From baseline to week 24)
- Relative change from baseline in 2h-PPG at week 12 and week 24(From baseline to week 12 and week 24)
- Relative change from baseline in weight at week 12 and week 24(From baseline to week 12 and week 24)
- Relative change from baseline in blood pressure at week 12 and week 24(From baseline to week 12 and week 24)
- Relative change from baseline in blood lipid level at week 12 and week 24(From baseline to week 12 and week 24)
- Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24(From baseline to week 24)
- Proportion of participants who received rescue treatment after 24 weeks of treatment(From baseline to week 24)
研究者
研究点 (1)
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