Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assessment of Changes in Glycemic Control by HbA1c.
研究概览
简要总结
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.
Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
详细描述
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years
排除标准
- •diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
研究组 & 干预措施
Liraglutide
Liraglutide, s.c., 1.8 mg, die, 24 weeks
干预措施: Liraglutide (Drug)
Placebo
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
干预措施: Placebos (Drug)
结局指标
主要结局
Assessment of Changes in Glycemic Control by HbA1c.
时间窗: Measure changes in HbA1c at 24 and 52 weeks from baseline
To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.
次要结局
- Assessment of Changes on Adipose Tissue(Measure changes in the composite at 24 and 52 weeks from baseline)