NCT04877366已完成不适用
A Randomized, Double-blind, Placebo- and Active-Controlled, Single-Center, Three-time-period, Crossover Study to Evaluate the Effects of Sprinkled Format REDUCOSE on Post-Prandial Glycemic Response in Asian Patients with Type 2 Diabetes
Société des Produits Nestlé (SPN)4 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Post-prandial glycemic excursion (ARMs A and B)
研究概览
简要总结
This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to sign written informed consent prior to study entry.
- •Participants who self-identify as Asian; male or female, >18 years of age.
- •Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).
- •Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- •Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
- •Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
排除标准
- •Fasting plasma glucose >220 mg/dl at screening.
- •Impaired kidney function, eGFR of <60 mL/min/1.73 m2 at screening.
- •BMI >35 kg/m
- •Weight ≤ 50 kg.
- •Elevated liver transaminase > 3 ULN at screening.
- •Ongoing or recent (i.e. < 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.
- •Ongoing or recent (i.e. < 3 month) injectable insulin therapy.
- •Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
- •Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
- •Major medical/surgical event requiring hospitalization in the last 3 months.
- •Known allergy and intolerance to product components or paracetamol.
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- •Are unable to comply with protocol procedures in the opinion of the investigator.
- •Have a hierarchical link with the research team members.
- •Positive pregnancy test or breast-feeding at screening.
- •Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
- •Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
结局指标
主要结局
Post-prandial glycemic excursion (ARMs A and B)
时间窗: 0 ,15, 30, 60, 120, and 180 minutes.
Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h).
次要结局
- Plasma glucose Tmax (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- Plasma interleukin-6 (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- Total glucose (All ARMS)(0 ,15, 30, 60, 120, and 180 minutes.)
- Plasma GLP-1 (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- Serum insulin (All ARMs)(0 ,15, 30, 60, 120, and 180 minutes.)
- Plasma GIP (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- 2h post-prandial glucose levels (ARMs A and B)(0 ,15, 30, 60, and 120 minutes.)
- Plasma glucose iCmax (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- Plasma glucose AUC (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- Gastric emptying (ARMs A and B)(0 ,15, 30, 60, 120, and 180 minutes.)
- Matsuda Index (ARMs A and B)(0, 30, 60, and 120 minutes.)
研究者
研究点 (4)
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