Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in 15-minute post prandial insulin level
研究概览
简要总结
This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.
It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.
详细描述
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.
Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.
All subjects will be under direct supervision of a medical doctor during the study period.
All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with age of 18-60 years
- •Prediabetic patients (2h-PPPG level of 140-199 mg/dL)
- •Serum ALT ≤ 2.5 times upper limit of normal
- •Serum creatinine < 1.5 times upper limit of normal
- •Able to take oral medication
排除标准
- •Female of childbearing potential
- •History of diabetes mellitus
- •History of symptomatic coronary arterial disease, stroke, and cardiovascular events
- •Current treatment with systemic corticosteroids or herbal (alternative) medicines
- •Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation
- •Participation in any other clinical studies within 30 days prior to screening
研究组 & 干预措施
DLBS3233
干预措施: DLBS3233 (Drug)
Placebo of DLBS3233
干预措施: Placebo of DLBS3233 (Drug)
结局指标
主要结局
Change in 15-minute post prandial insulin level
时间窗: 12 weeks of treatment
Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment
次要结局
- Change in 15-minute post prandial insulin level(8 weeks of treatment)
- Change in 2-hour post prandial insulin level(8 weeks and 12 weeks of treatment)
- Change in 15-minute post prandial plasma glucose(8 weeks and 12 weeks of treatment)
- Change in 2-hour post prandial plasma glucose(4 weeks, 8 weeks, and 12 weeks of treatment)
- Change in HOMA-IR(8 weeks and 12 weeks of treatment)
- Change in hs-CRP(8 weeks and 12 weeks of treatment)
- Improvement in lipid profile(8 weeks and 12 weeks of treatment)
- Change in adiponectin(8 weeks and 12 weeks of treatment)
- Change in waist-to-hip ratio(4 weeks, 8 weeks, and 12 weeks of treatment)
- ECG(12 weeks of treatment)
- Vital signs(4 weeks, 8 weeks, and 12 weeks of treatment)
- Body weight(4 weeks, 8 weeks, and 12 weeks of treatment)
- Liver function(12 weeks of treatment)
- Renal function(12 weeks of treatment)
- Adverse events(1-12 weeks of treatment)