UnknownPhase 4

Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes Insufficiently Controlled by Insulin Glargine and Metformin Combination Therapy

Lead sponsor

Chungbuk National University Hospital

Assets

Dulaglutide / Lixisenatide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•HbA1c, change

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 IDNCT04893148

Org study IDGLP1RA2021

Timeline

Milestones

Study start2020-05-26actual

Study first posted2021-05-19actual

Primary completion2021-12-30actual

Last update posted2022-07-20actual

Study completion2022-12-30estimated

Assets

Investigational agents

Dulaglutide Lixisenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years old

•Patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks

•Patient accepting to participant to this study

Exclusion criteria

•Pregnant or breastfeeding woman

•severe renal dysfunction (eGFR <60 ml/min/1.73m2)

•chronic or acute hepatic disorder (HBV or HCV hepatitis, liver cirrhosis etc.) (AST/ALT > 2.5*ULN)

•Prescription such as immunosuppressant agents, glucocorticoids

•Active anti-cancer treatment

Endpoints (7)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Changes in weight

Time frame:Baseline, week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Changes in glycated hemoglobin (HbA1c)

Time frame:Baseline, week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes in fasting plasma glucose (FPG)

Time frame:Baseline, week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes in glucose time in range (TIR)

Time frame:Baseline, week 12

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Changes in glucose time above range (TAR)

Time frame:Baseline, week 12

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Changes in glucose time below range (TBR)

Time frame:Baseline, week 12

CGM time-below-range

percent change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of hypoglycemia

Time frame:Baseline, week 12

event count, event

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.