The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy

Study Overview
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Brief Summary
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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.

Official Title
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The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Add oral hyppoglycemia drug
* Other: Add GLP-1 receptor agonist
* Other: Change insulin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral hyppoglycemia drug group<br>Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose. | Other: Add oral hyppoglycemia drug<br>* Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose<br>|
| Active Comparator: GLP-1RA group<br>Add GLP-1 receptor agonists to reduce insulin dose. | Other: Add GLP-1 receptor agonist<br>* Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose<br>|
| Active Comparator: long-acting insulin group<br>Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs | Other: Change insulin<br>* Change premix insulin to long-acting insulin<br>|
| No Intervention: Control group<br>continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin autoimmune antibody | The change of insulin autoimmune antibody | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | The change of glycated hemoglobin | 3 month | 
| Time in range | The change of time in range | 3 month | 
| Time below range | The change of time below range | 3 month | 
| B cell | the change of B cell subsets | 3 month | 
| T cell | the change of T cell subsets | 3 month |