NCT02898506已完成2 期
Incretin-based Therapy in Late Preclinical 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
- 13
- 试验地点
- 4
- 主要终点
- FPIR (1+3min serum insulin level after iv glucose infusion)
研究概览
简要总结
The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.
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
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-30 years of age
- •positive for at least 2 islet autoantibodies
- •glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT
- •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 at least 3.4pmol/l)
- •presence of any chronic metabolic, hematologic or malignant disease
- •obesity BMI at least 30
- •pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
- •breast-feeding
研究组 & 干预措施
Liraglutide
Active Comparator
Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®
干预措施: Victoza® (Drug)
Placebo
Placebo Comparator
Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FPIR (1+3min serum insulin level after iv glucose infusion)
时间窗: 12 months
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)
次要结局
- Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia(12 months)
- Tolerability(12 months)
- Serum C-peptide AUC(12 months)
研究者
Riitta Veijola
Professor
University of Oulu
研究点 (4)
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