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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Add oral hyppoglycemia drug; Other: Add GLP-1 receptor agonist; Other: Change insulin

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianhua Ma, Professor; Phone Number: +862552887091; Email: majianhua196503@126.com

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • Nanjing First Hospital, Nanjing Medical Univesity
    • Contact: Jianhua Ma, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral hyppoglycemia drug group; Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.	Other: Add oral hyppoglycemia drug; Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
Active Comparator: GLP-1RA group; Add GLP-1 receptor agonists to reduce insulin dose.	Other: Add GLP-1 receptor agonist; Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
Active Comparator: long-acting insulin group; Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs	Other: Change insulin; Change premix insulin to long-acting insulin
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: Jianhua Ma, Professor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: KY2022-8-5-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No