NCT01188200已完成3 期
Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 22
- 主要终点
- The primary variable is glucose concentration
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of a nutritional formula in 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has type 2 diabetes.
- •Subject is over 18 years of age.
- •Subject is a male, or a non-pregnant, non-lactating female.
- •Subject's BMI is > 20 kg/m2 and < 40 kg/m
- •Subject's HbA1c level is 6.5 - 11%.
- •If on a chronic thyroid medication or hormone replacement therapy, subject has been on constant dosage for at least two months prior to Screening Visit.
- •Subject's weight is stable for the past two months prior to Screening Visit.
排除标准
- •Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control.
- •Subject has type 1 diabetes.
- •Subject has history of diabetic ketoacidosis.
- •Subject has the following: current infection ; has had inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or antibiotics in the last 3 weeks prior to screening.
- •Subject has an active malignancy.
- •Subject has had significant cardiovascular event <6 months prior to study entry or history of congestive heart failure.
- •Subject has end stage organ failure.
- •Subject has history of severe gastroparesis, renal or hepatic disease.
- •Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes.
- •Subject has a chronic, contagious, infectious disease.
- •Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose.
- •Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study.
- •Clotting or bleeding disorders.
- •Allergic or intolerant to any ingredient found in the test meal.
结局指标
主要结局
The primary variable is glucose concentration
时间窗: 0 to 240 minutes
次要结局
- Additional measures of glucose concentration(0 to 240 mins)
研究者
研究点 (22)
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