NCT00867594已完成2 期
A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
研究概览
简要总结
The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus
- •Male or female aged 18-50 years inclusive
- •Body weight between 50-100kg and BMI between 18 and 30 kg/m2
- •Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia
- •No other medical problems
排除标准
- •History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Positive pregnancy test or lactation
- •Lack of family support
- •Unwilling or unable to follow the study protocol
- •Concurrent medical problems
结局指标
主要结局
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes
时间窗: 15 days
次要结局
- To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes(15 days)
研究者
研究点 (2)
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