A Trial Investigating the Efficacy and Safety of LC-Z300-01 in Adults With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.
详细描述
This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.
Considering the rights and interests, the trial is divided into two phases. The first phase is a double-blind group, in which subjects are randomly assigned to the blank control group, the low-dose experimental group, and the high-dose experimental group to observe the changes in glycosylated hemoglobin and CGMS compared with the baseline, as well as safety events.
The second phase is an open-label group, in which the three groups are willing to freely enter the high-dose experimental group and further observe recovery and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The total duration of the trial for individuals participating in this clinical trial is up to 30 weeks, including:
- 3-week screening period,
- 1-week run-in period (may be extended to a maximum of 8 weeks),
- 12-week double-blind randomized, controlled intervention period,
- 12-week switching to high-dose conversion, open-label intervention period,
- 2-week follow-up period. For subjects with an extended run-in period, the trial duration can be up to 37 weeks.
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
- •Male or female, age reach and over 18 years at the time of signing informed consent,
- •Body mass index (BMI) between 18.0 and 35.0 kg/m^2 (both inclusive),
- •Type 2 diabetes mellitus (as diagnosed clinically) before screening.
- •hemoglobin A1c of 7.5 - 9.0% (both inclusive) as assessed by central laboratory on the day of screening,
- •Treated with stable doses of oral antidiabetic drugs (OADs) , insulin or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide, etc.) within 3 months prior to screening;
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method,
- •Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids),
- •Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening,
- •Presence or history of pancreatitis (acute or chronic) within 180 days before screening,
- •Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
- •Chronic heart failure classified as being in New York Heart Association Class IV at screening,
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.
研究组 & 干预措施
low-dose LC-Z300-01
Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 12-weeks of low-dose LC-Z300-01 randamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.
干预措施: Low-dose LC-Z300-01 twice daily in blinding (Drug)
low-dose LC-Z300-01
Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 12-weeks of low-dose LC-Z300-01 randamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.
干预措施: High-dose LCZ300-1 twice daily in open-label (Drug)
high-dose LC-Z300-01
Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.
干预措施: High-dose LC-Z300-01 twice daily in blinding (Drug)
high-dose LC-Z300-01
Experimental: placebo for runing-in + LC-Z300-01 Subjects will receive 24-weeks of high-dose LC-Z300-01.
干预措施: High-dose LCZ300-1 twice daily in open-label (Drug)
Placebo
Experimental: placebo + LC-Z300-01 Subjects will receive 12-weeks of placebo radamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.
干预措施: Placebo twice daily in blinding (Dietary Supplement)
Placebo
Experimental: placebo + LC-Z300-01 Subjects will receive 12-weeks of placebo radamizedly and then 12 weeks of high-dose LC-Z300-01 in open-label.
干预措施: High-dose LCZ300-1 twice daily in open-label (Drug)
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: From baseline week 0 to week 26
The differences in adverse events between the patients taking the drug and the placebo group were observed during the double-blind and open-label phases.
Change in glycated haemoglobin (HbA1c)
时间窗: From baseline week 0 to week 12 and to week 24
During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group.
次要结局
- Change in Time in Range (TIR)(From baseline week 0 to week 12 and to week 24)