Type 2 Diabetes Mellitus
Conditions
Brief summary
Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.
Interventions
OTHERAdd oral hyppoglycemia drug
Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
OTHERAdd GLP-1 receptor agonist
Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
OTHERChange insulin
Change premix insulin to long-acting insulin
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes; * Treated with premix insulin, two or three injections a day, single drug or combination of oral hypoglycemic drugs; * The treatment regimen was stable for more than 2 months; * With positive insulin antibody
Exclusion criteria
* Patients treated with GLP-1 agonist in the last 3 months; * Allergic to insulin; * Impaired liver and renal function (ALT 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal); * A history of drug abuse and alcohol dependence; * Used systemic glucocorticoids therapy in recent 3 months; * Patients with infection or stress within four weeks; * Patients who cannot tolerate FGM; * Pregnant or preparing to become pregnant; * Considered unsuitable to participate by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin autoimmune antibody | 3 month | The change of insulin autoimmune antibody |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 3 month | The change of glycated hemoglobin |
| Time in range | 3 month | The change of time in range |
| Time below range | 3 month | The change of time below range |
| B cell | 3 month | the change of B cell subsets |
| T cell | 3 month | the change of T cell subsets |
Countries
China
Contacts
Primary ContactJianhua Ma, Professor
Outcome results
None listed