A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study (DREAMS-1) to Evaluate the Efficacy and Safety of IBI362 in Chinese Type 2 Diabetes Patients With Poor Glycemia Control Only Through Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- HbA1c change from baseline at week 24
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control.
The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period.
Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c<8.5% or HbA1c ≥ 8.5% before randomization.
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 at least 2 months
- •Age ≥ 18 when signing the informed consent form
- •The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening
- •Maintain a stable diet and exercise lifestyle during the study
- •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)
- •Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 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 4.0 mg
①2mg, subcutaneously (SC), once a week* 4weeks;
②4mg, SC, once a week* 44weeks.
干预措施: IBI362 (Drug)
IBI362 6.0 mg
①2mg, SC, once a week* 4weeks;
②4mg, SC, once a week* 4weeks；
③6mg, SC, once a week* 40weeks.
干预措施: IBI362 (Drug)
placebo
-
placebo, SC, once a week* 24weeks;
-
2mg, SC, once a week* 4weeks;
-
4mg, SC, once a week* 4weeks；
-
6mg, SC, once a week* 16weeks.
干预措施: placebo (Other)
结局指标
主要结局
HbA1c change from baseline at week 24
时间窗: Baseline, 24 weeks
次要结局
- Time to peak plasma concentration (Tmax)(Baseline to 52 weeks)
- Safety, Incidence and severity of adverse events and correlation with study drug;(Baseline to 52 weeks)
- Proportion of subjects with HbA1c<7.0% at week 24(Baseline, 24 weeks)
- clearance rate (clearance, CL)(Baseline to 52 weeks)
- Time to peak plasma concentration (Cmax)(Baseline to 52 weeks)
- area under curve (AUC)(Baseline to 52 weeks)
- volume distribution (V)(Baseline to 52 weeks)
- half-life (half-life, T1/2)(Baseline to 52 weeks)
- To assess changes in PD parameters fasting insulin at different time points before and after administration.(Baseline to 52 weeks)
- To assess changes in PD parameters fasting C-peptide at different time points before and after administration.(Baseline to 52 weeks)