NCT01879917已完成2 期
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed 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
- 65
- 试验地点
- 1
- 主要终点
- Beta-cell function
研究概览
简要总结
The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
- •Age 18 - 40 years - both inclusive
- •Postprandial C-peptide > 0.2 nmol/l following sustacal meal test
- •Able to understand the written patient information and to give informed consent
排除标准
- •Type 2 diabetes
- •Body mass index <20 kg/m2
- •Pregnancy or unwillingness to use safe contraceptives
- •Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
- •Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0
研究组 & 干预措施
Liraglutide
Active Comparator
1.8 mg
干预措施: Liraglutide (Drug)
Saline
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Beta-cell function
时间窗: 52 weeks
To investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
次要结局
- Postprandial glucagon(52 weeks)
研究者
Thomas Dejgaard
MD
Hvidovre University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of Liraglutide in Parkinson's DiseaseParkinson DiseaseNCT02953665Cedars-Sinai Medical Center63
已完成
不适用
Treatment of Diabetic Neuropathy With LiraglutideType 1 Diabetes MellitusDiabetes Mellitus, Type 1NCT02138045Aalborg University Hospital39
已完成
4 期
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass SurgeryObesityNCT03048578NYU Langone Health132
已完成
3 期
A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 DiabetesType 2 Diabetes MellitusNCT04591626Eli Lilly and Company291
已完成
3 期
Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal InsulinMetabolism and Nutrition DisorderObesityNCT02963922Novo Nordisk A/S396