NCT00993720已完成2 期
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- insulin-dose
研究概览
简要总结
The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •age 18-50y,
- •BMI 18-27,
- •caucasian origin,
- •type 1 diabetes diagnosed between age 5 and age 40,
- •no known diabetes complications or cardiovascular diseases,
- •no medication known to influence glucose homeostasis,
- •no pregnancy
排除标准
- •diabetes complications,
- •autonomous nerve dysfunction,
- •HbA1c < 8.5% at screening,
- •estimated by the investigator to be incapable of completing the trial.
研究组 & 干预措施
type 1 DM with betacell function: Liraglutide
Experimental
干预措施: Liraglutide (Drug)
type 1 DM without betacell function: Liraglutide
Experimental
干预措施: Liraglutide (Drug)
type 1 DM without betacell function: Insulin
No Intervention
干预措施: continuous insulin therapy (Other)
结局指标
主要结局
insulin-dose
时间窗: 4 weeks
次要结局
- 24-hours glucose profiles with and without treatment of Victoza(three days)
- risk of hypoglycemia during physical activity with and without Victoza(one day)
- gastric emptying rate during hypoglycemia with and without Victoza(one day)
- weight change from baseline, change in fructosamine from baseline(four weeks)
研究者
研究点 (1)
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