Autoimmune Diabetes, Type 1 Diabetes Mellitus
Conditions
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.
Interventions
DRUGLiraglutide
Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
DRUGInsulin
Receive insulin following clinician's instruction.
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hyperglycemic and hypoglycemic events | 1 year | Blood sugar level higher than 11.1 mmol/l or lower than 3.9 mmol/l. |
| Change in HbA1C | 1 year | — |
| Change in C-peptide | 1 year | — |
| Change in insulin dose | 1 year | hyperglycemic and hypoglycemic events. |
| Life quality evaluation | 1 year | Number of subjects with disturbance of emotion, sleep, resting or energy. |
Countries
China
Contacts
Primary ContactZhiguang Zhou, MD/PhD
Outcome results
None listed