Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean amplitude of glycemic excursions (MAGE)
研究概览
简要总结
The purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.
详细描述
Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Glucagon-like peptide (GLP-1) analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in Type 2 diabetes and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide on glycemic control in AIDM.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes according to ADA criteria <3 years.
- •Age≥ 18 years.
- •Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
- •Fasting or postprandial plasma C-peptide more than 100 pmol/L
- •Written informed consent from the patient or family representative
排除标准
- •History or family history of medullary thyroid carcinoma or MEN 2 syndrome;
- •History of chronic or acute pancreatitis;
- •Allergic to liraglutide or any components in Victoza®;
- •Hepatic abnormalities (transaminase > 2 times normal);
- •Renal impairments (serum creatinine >133 umol/L);
- •Cardiovascular diseases (hypertension, coronary heart disease, etc.);
- •Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30;
- •Any history of malignancy;
- •Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years after recruitment;
- •Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory tract infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion;
- •Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
研究组 & 干预措施
Liraglutide + insulin
Patients will be subjected to a dose escalation of liraglutide up to 1.2 mg, then continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as routine therapy.
干预措施: Liraglutide (Drug)
Liraglutide + insulin
Patients will be subjected to a dose escalation of liraglutide up to 1.2 mg, then continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as routine therapy.
干预措施: Insulin (Drug)
Insulin
Patients will receive insulin injection as a routine therapy.
干预措施: Insulin (Drug)
结局指标
主要结局
Mean amplitude of glycemic excursions (MAGE)
时间窗: 1 year
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this one-year study.
次要结局
- Change in C-peptide(1 year)
- Change in HbA1C(1 year)
- Change in insulin dose(1 year)
- Hyperglycemic and hypoglycemic events(1 year)
- Life quality evaluation(1 year)
研究者
Zhiguang Zhou
Principal Investigator
Second Xiangya Hospital of Central South University