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

Nanjing Medical University

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Add oral hyppoglycemia drug; Other: Add GLP-1 receptor agonist; Other: Change insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05578352

KY2022-8-5-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Oral hyppoglycemia drug group

Active Comparator group

Description:

Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.

Treatment:

Other: Add oral hyppoglycemia drug

GLP-1RA group

Active Comparator group

Description:

Add GLP-1 receptor agonists to reduce insulin dose.

Treatment:

Other: Add GLP-1 receptor agonist

long-acting insulin group

Active Comparator group

Description:

Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs

Treatment:

Other: Change insulin

Control group

No Intervention group

Description:

continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control.