NCT05333835Unknown2 期
A 26-week, Randomized, Open-label, 3-arm Parallel, Treat-to-target Study Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin With or Without One Other Oral Anti-diabetic Drug
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in HbA1c at Week 26
研究概览
简要总结
The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-70 age years, both inclusive;
- •BMI is 20.0 to 40.0 kg/m2, both inclusive;
- •Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- •HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
- •At screening:
- •Treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose [MTD, ≥1000 mg]) for ≥3 months, or 2) Treatment with metformin at the above dose level combined with a second OAD (AGI, SU, TZD, glinides, DPP-4i or SGLT2i) on a stable dose (≥half of the max approved dose according to local label, or at the MTD) for ≥3 months.
排除标准
- •Use of systemic glucocorticoids within 3 months prior to the screening;
- •Use of weight loss drugs within 3 months prior to the screening.
- •Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes);
- •Laboratory findings at the screening visit:
- •Amylase and/or lipase >3 x upper limit of normal (ULN);
- •alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN;
- •Moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin;
- •Urinary albumin creatinine ratio (UACR) ≥300 mg/g;
- •Total bilirubin >2.0 x ULN;
- •Calcitonin ≥50 ng/L;
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；
- •Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures;
- •Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
- •Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
- •History of pancreatitis (acute or chronic);
- •Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；
研究组 & 干预措施
HR17031 injection
Experimental
干预措施: HR17031 injection (Drug)
INS068 injection
Active Comparator
干预措施: INS068 injection (Drug)
SHR20004 injection
Active Comparator
干预措施: SHR20004 injection (Drug)
结局指标
主要结局
Mean Change From Baseline in HbA1c at Week 26
时间窗: at Week 26
次要结局
- Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26(at Week 26)
- Mean Actual Daily Insulin Dose at Week 26(at Week 26)
- Mean Change From Baseline in Body Weight at Week 26(at Week 26)
- Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26(at Week 26)
- Number of Hypoglycaemic Episodes at Week 26(at Week 26)
研究者
研究点 (1)
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