A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
研究概览
简要总结
A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject is a non-smoker
排除标准
- •Subject has irritable bowel disease
- •Subject has a history of cancer
- •Subject has a history of hypertension requiring treatment
- •Subject is unable to refrain from the use of any prescription or non-prescription medication
- •Subject consumes excessive amounts of alcohol or caffeine
- •Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
研究组 & 干预措施
Treatment Sequence 6
C-B-A-C
干预措施: Comparator: Treatment A (Other)
Treatment Sequence 6
C-B-A-C
干预措施: Comparator: Treatment B (Drug)
Treatment Sequence 6
C-B-A-C
干预措施: Comparator: Treatment C (Drug)
Treatment Sequence 6
C-B-A-C
干预措施: Comparator: graded glucose infusion (Procedure)
Treatment Sequence 5
B-A-C-C
干预措施: Comparator: Treatment A (Other)
Treatment Sequence 5
B-A-C-C
干预措施: Comparator: Treatment B (Drug)
Treatment Sequence 5
B-A-C-C
干预措施: Comparator: Treatment C (Drug)
Treatment Sequence 5
B-A-C-C
干预措施: Comparator: graded glucose infusion (Procedure)
Treatment Sequence 1
A-B-C-C
干预措施: Comparator: Treatment A (Other)
Treatment Sequence 1
A-B-C-C
干预措施: Comparator: Treatment B (Drug)
Treatment Sequence 1
A-B-C-C
干预措施: Comparator: Treatment C (Drug)
Treatment Sequence 1
A-B-C-C
干预措施: Comparator: graded glucose infusion (Procedure)
Treatment Sequence 2
B-C-A-C
干预措施: Comparator: Treatment A (Other)
Treatment Sequence 2
B-C-A-C
干预措施: Comparator: Treatment B (Drug)
Treatment Sequence 2
B-C-A-C
干预措施: Comparator: Treatment C (Drug)
Treatment Sequence 2
B-C-A-C
干预措施: Comparator: graded glucose infusion (Procedure)
Treatment Sequence 3
C-A-B-C
干预措施: Comparator: Treatment A (Other)
Treatment Sequence 3
C-A-B-C
干预措施: Comparator: Treatment B (Drug)
Treatment Sequence 3
C-A-B-C
干预措施: Comparator: Treatment C (Drug)
Treatment Sequence 3
C-A-B-C
干预措施: Comparator: graded glucose infusion (Procedure)
Treatment Sequence 4
A-C-B-C
干预措施: Comparator: Treatment A (Other)
Treatment Sequence 4
A-C-B-C
干预措施: Comparator: Treatment B (Drug)
Treatment Sequence 4
A-C-B-C
干预措施: Comparator: Treatment C (Drug)
Treatment Sequence 4
A-C-B-C
干预措施: Comparator: graded glucose infusion (Procedure)
结局指标
主要结局
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
时间窗: 0-160 minutes after start of infusion
次要结局
- safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences(11 weeks)