NCT04026750终止1 期
A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
High Point Clinical Trials Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change From Baseline in Peak Glucagon Response to Hypoglycemia
研究概览
简要总结
The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria: Diagnosis of diabetes => 4yrs, On Insulin => 4yrs, HbA1c<= 10%, At least one episode of severe hypoglycemia in past 12 months, fasting c-peptide <0.7 ng/ml
排除标准
- •Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal function, Anxiety and depression
研究组 & 干预措施
Matching placebo
Placebo Comparator
干预措施: Pitolisant (Drug)
Pitolisant
Experimental
干预措施: Pitolisant (Drug)
结局指标
主要结局
Change From Baseline in Peak Glucagon Response to Hypoglycemia
时间窗: Change in peak glucagon during ITT Day 1 vs. Day 7
Change in peak glucagon concentration from day 1 ITT (baseline) to day 7 ITT (on treatment). Serial glucagon collected during ITT's, occurred at -10, 0, 15, 30, 45, 60, 90, 120 and 180 minutes just prior to and during the ITT.
次要结局
- Number of Patients Returning to Blood Glucose =>70 mg/dL(Day 7)
研究者
研究点 (1)
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