A Randomized, Double-blinded Placebo-controlled, Paralleled Designed, Investigator Sponsored Study of the Effect of the GLP-1 Receptor Agonist Liraglutide on Beta-cell Function in C-peptide Positive Type 1 Diabetic Patients
概览
- 阶段
- 2 期
- 干预措施
- Liraglutide
- 疾病 / 适应症
- Type 1 Diabetes
- 发起方
- Per-Ola Carlsson
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations >0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells.
The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.
研究者
Per-Ola Carlsson
Professor, senior consultant
Uppsala University Hospital
入排标准
入选标准
- •Written informed consent for participation of the study, given before undergoing any study-specific procedures.
- •18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
- •Clinical diagnose of T1D
- •Five or more years duration of disease
- •HbA1C between 45 and 75 mmol/mol
- •Fasting plasma C-peptide concentration \>1.5 pmol/l.
排除标准
- •Inability to provide informed consent
- •Mental incapacity
- •Unwillingness or language barrier precluding adequate understanding or cooperation
- •Ongoing or planned pregnancy within the next 12 months
- •Inadequate or no use of contraceptives
- •Ongoing breast feeding
- •Known sight-threatening retinopathy
- •Creatinine clearance \<60 ml/min
- •Life-threatening cardiovascular disease
- •History of drug/alcohol abuse
研究组 & 干预措施
Liraglutide treatment
Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks
干预措施: Liraglutide
Placebo treatment
Treatment with placebo once daily for 52 weeks
干预措施: Placebo for liraglutide
结局指标
主要结局
The effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production
时间窗: 52 weeks
The Area Under the Curve (AUC) change in plasma C-peptide concentration in response to a standardized mixed meal tolerance test (MMTT) during one year of liraglutide treatment (1.8 mg/day)
次要结局
- Change in C-peptide between 6 and 52 weeks of study(52 weeks)
- Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg(52 weeks)
- Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment(52 weeks)
- Change in HbA1c between 6 and 52 weeks of study(52 weeks)
- Change in glucose variability between before and at end of liraglutide (1.8 mg) treatment(52 weeks)
- Change in glucose variability between 6 and 52 weeks of study(52 weeks)
- Change in glucose variability between after and prior to treatment with liraglutide 1.8 mg(52 weeks)
- Change in hypoglycemia frequency between before and at end of liraglutide (1.8 mg) treatment(52 weeks)
- Change in hypoglycemia frequency between 6 and 52 weeks of study(52 weeks)
- Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg(52 weeks)
- Change in insulin doses between before and at end of liraglutide (1.8 mg) treatment(52 weeks)
- Change in insulin doses between 6 and 52 weeks of study(52 weeks)
- Change in insulin doses between after and prior to treatment with liraglutide 1.8 mg(52 weeks)
- Change in QoL between after and prior to treatment with liraglutide(52 weeks)
- Change in hypoglycemia frequency between after and prior to treatment with liraglutide 1.8 mg(52 weeks)
- Change in Quality of Life (QoL) between before and at end of liraglutide (1.8 mg)(52 weeks)
- Change in QoL between 6 and 52 weeks of study(52 weeks)