NCT05606913已完成3 期
Efficacy and Safety of IBI362 Versus Dulaglutide as add-on to Metformin and/or SGLT2 Inhibitor or TZD in Subjects With Type 2 Diabetes (DREAMS-2)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 731
- 试验地点
- 1
- 主要终点
- HbA1c change from baseline at week 28
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2D was diagnosed according to WHO standards in 1999 for
- •Age ≥ 18 when signing the informed consent form
- •After used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with SGLT2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, Henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤HbA1c≤11.0%.
- •BMI≥23 kg/m2 at screening.
- •Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol
排除标准
- •Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- •Weight change>5% within 12 weeks before screening (chief complaint)
- •Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening.
- •Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes
- •There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
- •Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
- •Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
- •The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
研究组 & 干预措施
IBI362 6.0mg
Experimental
①2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 4weeks；③6mg, SC, once a week* 20weeks.
干预措施: IBI362 (Drug)
dulaglutide
Experimental
1.5mg, SC, once a week* 28weeks
干预措施: dulaglutide (Drug)
IBI362 4.0mg
Experimental
2mg, SC, once a week* 4weeks; ②4mg, SC, once a week* 24weeks.
干预措施: IBI362 (Drug)
结局指标
主要结局
HbA1c change from baseline at week 28
时间窗: Baseline, 28 weeks
次要结局
- Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline(Baseline, 28 weeks)
- Proportion of subjects with HbA1c <7.0%(Baseline, 28 weeks)
- Time to peak plasma concentration (Tmax)(Baseline to 28weeks)
- area under curve (AUC)(Baseline to 28weeks)
- volume distribution (V)(Baseline to 28weeks)
- half-life (half-life, T1/2(Baseline to 28weeks)
- To assess changes in PD parameters fasting insulin at different time points before and after administration.(Baseline to 28weeks)
- Change from baseline in HbA1c (superiority)(Baseline, 28 weeks)
- Safety,Incidence and severity of adverse events and correlation with study drug;(Baseline to 32weeks)
- clearance rate (clearance, CL)(Baseline to 28weeks)
- percent change from baseline in body weigh(Baseline, 28 weeks)
- Time to peak plasma concentration (Cmax)(Baseline to 28weeks)
- To assess changes in PD parameters fasting C-peptide at different time points before and after administration.(Baseline to 28weeks)
研究者
研究点 (1)
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