Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
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
- Serum C-peptide AUC
研究概览
简要总结
The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.
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
- 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
- •early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
- •not pregnant.
排除标准
- •allergic to liraglutide or other ingredients of Victoza®
- •diabetic ketoacidosis
- •previous treatment in the last three months with any antidiabetic medication other than insulin
- •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® (liraglutide)
Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®
干预措施: Victoza® (liraglutide) (Drug)
Placebo
Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin are treated with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum C-peptide AUC
时间窗: From baseline to 26 and 52 weeks
Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)
次要结局
- Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored(From baseline to 26 and 52 weeks)
- Number of hypoglycemia episodes(From baseline to 26 and 52 weeks)
- Frequency of gastrointestinal side effects(12 months)
- Insulin dose(From baseline to 26 and 52 weeks)
研究者
Riitta Veijola
Professor
University of Oulu