Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Reduction of A1c level
研究概览
简要总结
This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.
详细描述
There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening
- •Diagnosed with type-2 diabetes mellitus
- •Have been being treated with a combination of two OHA for at least 3 months prior to screening
- •A1c level of >= 7.0 %
- •Hemoglobin level of >= 10 g/dL
- •Body Mass Index (BMI) > 18.5 kg/m2
- •Refuse insulin therapy
- •Able to take oral medicine
排除标准
- •Subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
- •History of or current chronic treatment with insulin
- •History of renal and/or liver disease
- •Impaired liver function: serum ALT > 2.5 times upper limit of normal and positive result of chronic or acute hepatitis B or C test
- •Impaired renal function: serum creatinine >= 1.5 times upper limit of normal
- •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)
结局指标
主要结局
Reduction of A1c level
时间窗: 12 weeks
Reduction of A1c level from baseline after 12 weeks of treatment
次要结局
- Hematology(6 and 12 weeks)
- Liver function(6 and 12 weeks)
- Renal function(6 and 12 weeks)
- Reduction of venous FPG(6 and 12 weeks)
- Change in fasting insulin level(6 and 12 weeks)
- Change in HOMA-R(6 and 12 weeks)
- Change in HOMA-B(6 and 12 weeks)
- Change in adiponectin level(6 and 12 weeks)
- Change in lipid profile(6 and 12 weeks)
- Change in body weight(6 and 12 weeks)
- Reduction of venous A1c level(6 weeks)
- Reduction of venous 1h-PG(6 and 12 weeks)
- Adverse events(1-12 weeks)