NCT06881264已完成3 期
A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Change in HbA1c: Changes in HbA1c from baseline to week 26
研究概览
简要总结
The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years at the time of signing the informed consent (both ends included);
- •Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included);
- •Diagnosed with type 2 diabetes for at least 90 days prior to screening;
- •Tested by local laboratory, HbA1c is 7.5%-11% (including both ends);
- •Before screening, the daily basal insulin dose had been stabilized at 20-40 U/day (including both ends) for at least 60 days;
- •When screening: ① metformin monotherapy stable treatment ≥ 3 months; or ② metformin combined with another OAD for stable treatment for ≥ 3 months; Metformin dose ≥ 1500 mg/day or maximum tolerated dose.
- •Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.
排除标准
- •Known or suspected allergy to the investigational drug product or its components or excipients;
- •Systemic glucocorticoid use within 3 months prior to screening;
- •Use of weight loss drugs within 3 months prior to screening;
- •Received insulin therapy within 1 year prior to screening (excluding short-term therapy [continuous treatment ≤14 days] or insulin therapy for gestational diabetes);
- •Cardiovascular disease, defined as congestive heart failure (NYHA III-IV), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; And/or coronary, carotid, or peripheral arterial revascularization is planned at screening;
- •(with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
- •Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
- •Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
- •Known or suspected abuse of alcohol or narcotics;
- •Previous history of pancreatitis (acute or chronic);
- •During pregnancy or lactation;fertile women (WOCBP) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product;
- •Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
研究组 & 干预措施
Treatment group A: HR17031 injection
Experimental
干预措施: HR17031 injection (Drug)
Treatment group B: insulin glargine
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in HbA1c: Changes in HbA1c from baseline to week 26
时间窗: week 26
次要结局
- Proportion of subjects achieved HbA1c<7.0% at week 26(at week 26)
- Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52(at week 52)
- Change in body weight from baseline after 26 weeks of treatment(26 weeks)
- Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26(week 26)
- Actual Daily Insulin dose at week 26(week 26)
- Proportion of subjects achieved HbA1c≤6.5% at week 26(week 26)
- Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment(26 weeks)
- Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26(week 26)
- Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment(12weeks)
- Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment(12weeks)
- Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26(at week 26)
- Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26(at week 26)
- Proportion of subjects achieved HbA1c<5.7% at week 26(at week 26)
- Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;(week 26;)
- Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment(26 weeks)
- Changes in HbA1c from baseline after 52 weeks of treatment(52 weeks)
- Changes in FBG from baseline after 52 weeks of treatment(52 weeks)
- Changes in body weight from baseline after 52 weeks of treatment(52 weeks)
- Proportion of subjects achieved HbA1c<7% at week 52(at week 52)
- Proportion of subjects achieved HbA1c≤6.5% at week 52(at week 52)
- Proportion of subjects achieved HbA1c<7% without body weight gain at week 52(at week 52)
- Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52(at week 52)
- Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52(at week 52)
- Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52(at week 52)
- Proportion of subjects achieved HbA1c<5.7% at week 52(at week 52)
- Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52(week 52)
- Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment(52 weeks)
- Actual Daily Insulin dose at week 52(at week 52)
- Number of Treatment-emergent Hypoglycemic event from screening to week 53(from screening to week 53)
- Number of Treatment-emergent Adverse Events from screening to week 53(from screening to week 53)
- Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27(at week 27)
研究者
研究点 (1)
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