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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Add GLP-1 receptor agonist; Other: Change insulin; Other: Add oral hyppoglycemia drug

• Registration Number: NCT05578352
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-05
• Status Verified: 2022-10
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLP-1RA group	Add GLP-1 receptor agonist	Add GLP-1 receptor agonists to reduce insulin dose.
long-acting insulin group	Change insulin	Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs
Oral hyppoglycemia drug group	Add oral hyppoglycemia drug	Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.

Primary Outcome Measures

Name	Time	Method
Insulin autoimmune antibody	3 month	The change of insulin autoimmune antibody

Secondary Outcome Measures

Name	Time	Method
Time below range	3 month	The change of time below range
B cell	3 month	the change of B cell subsets
HbA1c	3 month	The change of glycated hemoglobin
Time in range	3 month	The change of time in range
T cell	3 month	the change of T cell subsets

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical Univesity; 🇨🇳 Nanjing, China