A randomized, double-blind, placebo-controlled, clinical study to evaluate the effect CUQ1720 on the postprandial response in healthy subjects and as an adjuvant to metformin in diabetic subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in post prandial Blood sugar level
研究概览
简要总结
This is a randomized (1:1:1:1), double-blind, four arm, placebo-controlled clinical study. Healthy and diabetic subjects meeting all inclusion and exclusion criteria will be enrolled in the study after signing a written informed consent. The subjects will be categorized as healthy and diabetic according to their fasting blood sugar and Hb1Ac levels.Subjects will be requested to undergo overnight fasting for at least 10 hours before each visit and to maintain their typical diet, physical activity, and general lifestyle throughout the study. The subjects post-prandial blood sugar testing will be done at defined time intervels, after consumption of standard breakfast. Efficacy of the product will be established based on post prandial results, bio marker assessments and based on the Questionnaire based assessments. The safety of the subjects also will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI of 18-30 kg/m2.
排除标准
- •For Healthy Subjects
- •Fasting Blood Sugar < 110 mg/dl
- •Hb1Ac less than 5.7 % For diabetic Subjects 1.Fasting Blood Sugar ≥ 120 to ≤ 150 mg/dl 2.Hb1Ac: Greater than 6.5 % 3.Subjects on metformin 500 mg, twice a day, since past 3 months 4.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening 5.Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study 6.Must be willing and able to give informed consent and comply with the study procedures.
结局指标
主要结局
Change in post prandial Blood sugar level
时间窗: Day 0, Day 28
次要结局
- Changes in Bio markers, Questionnaire based assessments and over all safety of the Subjects(Day 0, Day 28)