NCT02611232Unknown2 期
Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- FPIR (first phase insulin response)
研究概览
简要总结
The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-30 years of age
- •positive for at least 2 biochemical islet autoantibodies
- •have normal glucose tolerance in OGTT
- •are not pregnant
排除标准
- •allergic to liraglutide or other ingredients of Victoza®
- •Type 1 diabetes
- •diabetic ketoacidosis
- •previous treatment in the last three months with any antidiabetic medication
- •impaired liver or kidney function or on dialysis
- •severe heart failure
- •severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
- •past or current history of pancreatitis
- •serum calcitonin value above normal (>50 ng/l or ≥3.4pmol/l)
- •presence of any chronic metabolic, hematologic or malignant disease
- •obesity BMI ≥30
- •pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
- •breast-feeding
研究组 & 干预措施
Victoza®
Active Comparator
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)
干预措施: Victoza® (Drug)
Placebo
Placebo Comparator
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FPIR (first phase insulin response)
时间窗: From baseline to 26 and 104 weeks
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )
次要结局
- Serum C-peptide AUC(From baseline to 26 and 104 weeks)
- Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia(From baseline to 26 and 104 weeks)
- Tolerability(From baseline to 26 and 104 weeks)
研究者
Riitta Veijola
Professor
University of Oulu
研究点 (3)
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