Pasireotide for Prevention of Hypoglycemia in Patients With Hyperinsulinemic Hypoglycemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Hypoglycemia
研究概览
简要总结
This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.
详细描述
Pasireotide is a somatostatin analog with affinity for several somatostatin receptors including those on pancreatic beta cells; when activated these receptors affect the secretion of glucagon and insulin. Pasireotide is also known to decrease glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) secretion. Hyperglycemia is a well-documented adverse effect of pasireotide in its approved indications for treatment of Cushing's disease and acromegaly.
In light of this, the investigators hypothesize that pasireotide may be an effective therapy for hypoglycemia due to hyperinsulinism. Therefore a small controlled pilot study to assess the effect of subcutaneous (s.c.) pasireotide on preventing hypoglycemia due to hyperinsulinism over 7 hours of observation in both fasting and fed states is proposed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Normal saline s.c. injection once
干预措施: Saline Solution (Drug)
Pasireotide
Pasireotide 0.6mg s.c. once
干预措施: Pasireotide 0.6Mg Solution for Injection (Drug)
结局指标
主要结局
Hypoglycemia
时间窗: 7 hours
Occurence, frequency and severity of hypoglycemia (serum glucose \< 55 mg/dL)
次要结局
- Serum glucose regulators(7 hours)