GOAL

Completed

GOAL: A Research Study Looking at Long Term Blood Sugar Control in People With Type 2 Diabetes Treated With Xultophy® in Local Clinical Practice in Japan.

A Non-interventional, Single-arm, Multicentre, Prospective Study Investigating the Glycaemic Control and Treatment Pattern Associated With the Use of Xultophy® (IDegLira) in a Real-world Adult Population With Type 2 Diabetes Mellitus in Japan. GOAL (Glycaemic Outcome Assessment IDegLira) Study

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

244

actual

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 IDNCT04838743

Org study IDNN9068-4743

Secondary IDjRCT1051210008JAPIC (Japan)

Secondary IDU1111-1253-2025World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-04-09actual

Study start2021-04-23actual

Primary completion2022-10-26actual

Study completion2022-10-26actual

Last update posted2025-12-31actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Real-world adult population with type 2 diabetes mellitus in Japan

Inclusion criteria

•Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

•The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

•Male or female, age above or equal to 20 years at the time of signing informed consent

•Diagnosed with T2DM (Type 2 diabetes mellitus ) above or equal to 180 days prior to initiation of Xultophy® treatment.

•Treated with any oral anti-hyperglycaemic medication(s), except for oral GLP-1 RAs, for at least 60 days prior to initiation of Xultophy® treatment.

•Available and documented HbA1c value less or equal to 12 weeks prior to initiation of Xultophy® treatment.

Exclusion criteria

•Previous participation in this study. Participation is defined as having given informed consent in this study.

•Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before prior to initiation of Xultophy® (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening.).

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 60 days prior to initiation of Xultophy® treatment. However, short term insulin treatment for a maximum of 14 days prior to initiation of Xultophy® treatment is allowed, as is prior insulin treatment for gestational diabetes.

•Previous treatment with Xultophy®.

•Female who is known pregnant, breast-feeding or intends to become pregnant.

•Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

•Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Xultophy® label in Japan.

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

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in local laboratory measured HbA1c (Glycated haemoglobin )

Time frame:From baseline (Visit 1) to 26 weeks (Visit 3)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in local laboratory measured FPG (Fasting plasma glucose )

Time frame:From baseline (Visit 1) to 26 weeks (Visit 3)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in concomitant OAD(s) (Oral antidiabetic drugs ) including change in number, class, and frequency of concomitant OAD(s), after initiation of treatment of Xultophy® (Yes/No)

Time frame:From baseline (Visit 1) to 26 weeks (Visit 3)

categorical status, descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy®

Time frame:From baseline (Visit 1) to 26 weeks (Visit 3)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy®

Time frame:From baseline (Visit 1) to 26 weeks (Visit 3)

Severe hypoglycemia

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in daily dose of Xultophy®

Time frame:From baseline (Visit 1) to 26 weeks (Visit 3)

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.