Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
- Conditions
- Type 1 Diabetes MellitusAutoimmune Diabetes
- Interventions
- Registration Number
- NCT03011008
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- Brief Summary
The purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide + insulin 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. Insulin Insulin Patients will receive insulin injection as a routine therapy. Liraglutide + insulin Liraglutide 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.
- Primary Outcome Measures
Name Time Method Mean amplitude of glycemic excursions (MAGE) 1 year MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this one-year study.
- Secondary Outcome Measures
Name Time Method Change in C-peptide 1 year Change in HbA1C 1 year Change in insulin dose 1 year hyperglycemic and hypoglycemic events.
Hyperglycemic and hypoglycemic events 1 year Blood sugar level higher than 11.1 mmol/l or lower than 3.9 mmol/l.
Life quality evaluation 1 year Number of subjects with disturbance of emotion, sleep, resting or energy.
Trial Locations
- Locations (1)
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China