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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578352
• Other study ID #: KY2022-8-5-01
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jianhua Ma, Professor
• Phone: +862552887091
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Add oral hyppoglycemia drug
Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
• Add GLP-1 receptor agonist
Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
• Change insulin
Change premix insulin to long-acting insulin

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical Univesity	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin autoimmune antibody	The change of insulin autoimmune antibody	3 month
Secondary	HbA1c	The change of glycated hemoglobin	3 month
Secondary	Time in range	The change of time in range	3 month
Secondary	Time below range	The change of time below range	3 month
Secondary	B cell	the change of B cell subsets	3 month
Secondary	T cell	the change of T cell subsets	3 month