Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Reduction of A1c level
研究概览
简要总结
This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.
详细描述
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy.
Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.
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
- 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
- •BMI ≥ 18.5 kg/m2
- •Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%)
- •FPG ≤ 183 mg/dL
- •Hemoglobin level of ≥ 10.0 g/dL
- •Serum ALT ≤ 2.5 times upper limit of normal
- •Serum creatinine < 1.5 times upper limit of normal
排除标准
- •Female of childbearing potential
- •Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
- •Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
- •History of renal and/or liver disease
- •History of or the presence of any clinical evidence of malignancies
- •Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
- •Current treatment with systemic corticosteroids or herbal (alternative) medicines
- •Participation in any other intervention trial within 30 days prior to Screening
研究组 & 干预措施
Treatment I (control)
Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification
干预措施: Placebo of DLBS3233 (Drug)
Treatment I (control)
Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification
干预措施: Lifestyle modification (Other)
Treatment II
100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
干预措施: DLBS3233 (Drug)
Treatment II
100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
干预措施: Lifestyle modification (Other)
结局指标
主要结局
Reduction of A1c level
时间窗: 12 weeks
Reduction of A1c level from baseline to Week 12 of treatment
次要结局
- Reduction of venous FPG(6 weeks and 12 weeks)
- Change in HOMA-IR(12 weeks)
- Reduction of venous 2h-PG(6 weeks and 12 weeks)
- Response rate(12 weeks)
- Change in fasting insulin level(12 weeks)
- Liver function(12 weeks)
- Change in HOMA-B(12 weeks)
- Change in adiponectin level(12 weeks)
- Change in lipid profile(12 weeks)
- Vital signs(6 weeks and 12 weeks)
- Renal function(12 weeks)
- Adverse events(12 weeks)
- Change in body weight(6 weeks and 12 weeks)
- Electrocardiography (ECG)(12 weeks)