DelfaGLP-1 Atlas

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Completed

Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Lead sponsor

Novo Nordisk A/S

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

32

Recruiting sites

—

Enrollment

750

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT04952779
Org study IDNN9068-4445
Secondary ID1111-1211-7084World Health Organization

Timeline

Milestones

Study start2021-06-02actual
Study first posted2021-07-07actual
Primary completion2024-12-15actual
Study completion2024-12-15actual
Last update posted2025-12-31actual

Assets

Investigational agents

GLP-1 / incretin class catch-allLiraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age19 Years
SexAll
Sampling methodNon probability sample

Study population text

Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.

Inclusion criteria

•The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study.
•Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
•Male or female, age 19 years or older at the time of signing informed consent form.
•Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label).

Exclusion criteria

•Participants who are or have previously been on Xultophy® therapy.
•Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).
•Previous participation in this study. Participation is defined as having given informed consent in this study.
•Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Endpoints (14)

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
8
Weight & body composition
2
Safety / tolerability / PK
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Visit 1 (0 week), Visit 3 (13 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:Visit 1 (0 week), Visit 4 (26 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints
Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Visit 1 (0 week), Visit 3 (13 weeks)

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:Visit 1 (0 week), Visit 4 (26 weeks)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Individuals achieving HbA1c target less than 7.0 %

Time frame:Visit 1 (0 week), Visit 3 (13 weeks)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Individuals achieving HbA1c target less than 7.0 %

Time frame:Visit 1 (0 week), Visit 4 (26 weeks)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)

Time frame:Visit 1 (0 week), Visit 3 (13 weeks)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)

Time frame:Visit 1 (0 week), Visit 4 (26 weeks)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

Time frame:Visit 1 (0 week), Visit 3 (13 weeks)

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

Time frame:Visit 1 (0 week), Visit 3 (26 weeks)

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Incidence of Adverse Events (AEs) by preferred term

Time frame:baseline (Visit1, 0 week) to 26 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia

Time frame:Visit1 (0 week) to 26 weeks

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change of Xultophy® dose

Time frame:Visit 1 (0 week), 13 weeks (Visit 3)

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change of Xultophy® dose

Time frame:Visit (0 week), Visit 4 (26 weeks)

change from baseline, descriptive

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.