UnknownPhase NA

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

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•Insulin autoimmune antibody

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05578352

Org study IDKY2022-8-5-01

Timeline

Milestones

Study start2022-08-05actual

Study first posted2022-10-13actual

Last update posted2022-10-13actual

Primary completion2023-01-31estimated

Study completion2023-01-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Type 2 diabetes

Who can enroll

SexAll

Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Other (unclassified)

Safety / tolerability / PK

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

HbA1c

Time frame:3 month

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time in range

Time frame:3 month

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Time below range

Time frame:3 month

CGM time-below-range

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Insulin autoimmune antibody

Time frame:3 month

change from baseline, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

B cell

Time frame:3 month

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

T cell

Time frame:3 month

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.