An Open-Label, Randomized, Active-controlled, Multicentric Study to Assess the Efficacy and Safety of PDM011011 Capsules as Compared to Metformin in Subjects 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
- 150
- 试验地点
- 9
- 主要终点
- Mean change in fasting plasma glucose between active and comparator groups
研究概览
简要总结
Diabetes management primarily involves diet and lifestyle modifications followed by treatment with oral agents. Treatment with diet, insulin and oral agents like sulfonylurea, or metformin is known to improve glycemia. The main constituent of PDM011011 is a powder of the natural juice of Karela or bitter melon. Karela is an edible vegetable item in Indian food and has been known for his blood sugar lowering as well as lipid lowering capabilities. Several studies and anecdotal evidence show that bitter melon capsules are associated with improved glycemic control, lower post-prandial sugar levels and triglyceride levels, which help in decreasing the risk for coronary heart diseases.
Based on promising response in previous user trials and innovation in the extraction process, PHL proposed a comparative trial to evaluate the efficacy and safety of bitter melon capsule versus metformin, which is the standard of choice in patients of type 2 diabetes mellitus.
This is the first human trial with this product and hence, no prior clinical data is available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetic patients with an HbA1c between 7 to 10% and fasting plasma glucose between 110 mg/dl and 250 mg/dl.
排除标准
- •Patients of type 1 diabetes, secondary diabetes mellitus, pregnany or lactating women, with any other clinically significant abnormalities.
结局指标
主要结局
Mean change in fasting plasma glucose between active and comparator groups
时间窗: Baseline and week 15
次要结局
- Mean change in HbA1c between active and comparator groups(Baseline and week 15)