NCT05966272已完成2 期
A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c after 20 weeks of treatment
研究概览
简要总结
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ,18-65 years of age, agreed and signed the informed consent
- •Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
- •Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- •HbA1c 7.5-10.5% (both inclusive) at screening visit.
排除标准
- •Presence of any clinically significant results in examination at screening visit.
- •Uncontrollable hypertension.
- •A history of type 1 diabetes, specific diabetes, or secondary diabetes.
- •Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- •Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- •Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
- •Surgery is planned during the trial.
- •Mentally incapacitated or speech-impaired.
- •Pregnant or lactating woman.
- •In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
研究组 & 干预措施
Treatment group A
Experimental
HRS9531 injection dose level 1
干预措施: HRS9531 injection (Drug)
Treatment group B
Experimental
HRS9531 injection dose level 2
干预措施: HRS9531 injection (Drug)
Treatment group C
Experimental
HRS9531 injection dose level 3
干预措施: HRS9531 injection (Drug)
Treatment group D
Experimental
HRS9531 injection dose level 4
干预措施: HRS9531 injection (Drug)
Treatment group E
Placebo Comparator
HRS9531 injection Placebo dose level 1
干预措施: HRS9531 injection Placebo (Drug)
Treatment group F
Placebo Comparator
HRS9531 injection Placebo dose level 2
干预措施: HRS9531 injection Placebo (Drug)
Treatment group G
Placebo Comparator
HRS9531 injection Placebo dose level 3
干预措施: HRS9531 injection Placebo (Drug)
Treatment group H
Placebo Comparator
HRS9531 injection Placebo dose level 4
干预措施: HRS9531 injection Placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c after 20 weeks of treatment
时间窗: Week 0 to Week 20
次要结局
- Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment(Week 0 to Week 32)
- Change from baseline body Weight and waist circumference after 20 weeks of treatment(Week 0 to Week 20)
- Number of Participants With Anti-HRS9531 Antibody(Week 0 to Week 36)
- Number of AEs During the Trial(Week 0 to Week 36)
- Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment(Week 0 to Week 20)
- Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment(Week 0 to Week 32)
- Change from baseline in body Weight and waist circumference after 32 weeks of treatment(Week 0 to Week 32)
- Change From Baseline in HbA1c after 32 weeks(Week 0 to Week 32)
- Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment(Week 0 to Week 20)
研究者
研究点 (1)
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