DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT04893148

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

Assets

Dulaglutide / Lixisenatide

Listed sites

1

Recruiting sites

—

Enrollment

40

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

DulaglutideLixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

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
5
Weight & body composition
1
Safety / tolerability / PK
1

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 1, 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 1, 2026 snapshot.