Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Difference of insulin daily doses at week 24 and at the beginning of the study
研究概览
简要总结
The purpose of this study is to assess the efficacy of Diamel (dietary supplement) administration in the treatment of patients with type 2 diabetes receiving insulin therapy. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of patients to be recruited and randomized for the study is 116. Daily insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after 24 weeks of treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with insulin therapy regimen of two daily doses.
- •Signed informed consent.
排除标准
- •Type 1 diabetes.
- •Type 2 diabetes with glibenclamide treatment.
- •Nephropathy or liver condition diagnosed by clinical and/or biochemical examination.
- •Pregnancy.
- •HbA1c values greater than 10%.
结局指标
主要结局
Difference of insulin daily doses at week 24 and at the beginning of the study
时间窗: 24 weeks
Difference of glucose concentrations (fasting and post-prandial) at week 24 and at the beginning of the study considering the adjusted insulin doses during treatment
时间窗: 24 weeks
次要结局
- Occurrence of hypoglycemic episodes during treatment(24 weeks)
- Difference of HbA1c concentrations at week 24 and at the beginning of the study(24 weeks)
- Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study(24 weeks)