NCT05578352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 11, 2022

Last Update Submit

October 11, 2022

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Insulin autoimmune antibody

    The change of insulin autoimmune antibody

    3 month

Secondary Outcomes (5)

  • HbA1c

    3 month

  • Time in range

    3 month

  • Time below range

    3 month

  • B cell

    3 month

  • T cell

    3 month

Study Arms (4)

Oral hyppoglycemia drug group

ACTIVE COMPARATOR

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

Other: Add oral hyppoglycemia drug

GLP-1RA group

ACTIVE COMPARATOR

Add GLP-1 receptor agonists to reduce insulin dose.

Other: Add GLP-1 receptor agonist

long-acting insulin group

ACTIVE COMPARATOR

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

Other: Change insulin

Control group

NO INTERVENTION

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

Interventions

Add oral hyppoglycemia drugOTHER

Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose

Oral hyppoglycemia drug group
Add GLP-1 receptor agonistOTHER

Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose

GLP-1RA group
Change insulinOTHER

Change premix insulin to long-acting insulin

long-acting insulin group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jianhua Ma, Professor

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Jianhua Ma, Professor

CONTACT

+862552887091majianhua196503@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 13, 2022

Study Start

August 5, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

CN(1)