Latent autoimmune diabetes in adults
Conditions
Interventions
Experimental group:taking dorzagliatin
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (all 6 should be met) : 1. Able to understand the procedures and methods of this study, willing to complete this study in strict accordance with the clinical trial protocol, and willing to sign the informed consent. 2. The LADA patients included in this study are defined as follows: (1) Diagnosed of diabetes mellitus according to the WHO report in 1999; (2) Aged 18 years or above when diagnosed with diabetes mellitus; (3) Presence of beta-cell autoantibodies, mainly positive for glutamic acid decarboxylase antibody (GADA) (>18 U/ml); (4) No need for insulin therapy clinically within 6 months after the diagnosis of diabetes mellitus; 3. Fasting C-peptide (FCP) level >= 0.3 nmol/L; 4. Aged between 18 and 70 years; 5. Diabetes duration of 6 months to 3 years; 6. Outpatients or inpatients. Treated with insulin alone (continuous subcutaneous insulin infusion CSII or multiple subcutaneous injections MDI) or with metformin alone or both for more than 3 months, with insulin and metformin doses fluctuating by no more than 20% within 3 months, but with poor glycemic control (HbA1c > 7.0% within 3 months).
Exclusion criteria
Exclusion criteria: (excluded if one of them meets) : 1. Pregnancy, lactation or within two years of pregnancy plan; 2. Type 2 diabetes, gestational diabetes, or other specific types of diabetes; 3. ALT or AST more than three times the upper limit of normal, total bilirubin more than twice the upper limit of normal, triglycerides >= 5.7 mmol/L; 4. Creatinine levels >= 1.5 mg/dL(132µmol/L) for males and >=1.4 mg/dL (123µmol/L) for females or creatinine clearance <= 50 mL/min; 5. Patients with severe cardiovascular diseasesdigestive tract or blood system diseases; 6. Associated with other autoimmune diseases or severe immunodeficiency diseases; 7. Combined with malignant tumor; 8. With mental, neurological diseases, can not cooperate, poor compliance with diet, insulin, metformin treatment and monitor of blood glucose, or history of alcohol abuse or illegal drug abuse; 9. Have acute infection that may affect glycemic control or other stressful situations such as surgery within 4 weeks; 10. Treatment with immunomodulatory agents (such as hormones) or any other anti-diabetes drugs other than insulin and metformin within 3 months; 11. Allergic to dorzagliatin, medical-grade adhesives or any component of CGMS; 12. Taking participate in other clinical trials; 13. There are other reasons are not suitable for the clinical trial, according to the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean ampli- tude of glycemic excursion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time in range;Time above range;Time below range;Large amplitude of glucose excursion;Glycemic variability;Glycosylated hemoglobin;Glutamic acid decarboxylase antibody titre;Blood glucose;Lslet C peptide;Glucagon; | — |
Countries
China
Contacts
Public ContactJin Guoxi
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed