GLP-1 Peptide Atlas, by Delfa

Completed

A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

359

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥3%

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 IDNCT04666987

Org study IDNN9068-4740

Secondary IDU1111-1253-1809World Health Organization (WHO)

Timeline

Milestones

Study start2020-10-21actual

Study first posted2020-12-14actual

Primary completion2022-12-30actual

Study completion2023-02-10actual

Last update posted2024-04-03actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Sampling methodNon probability sample

Study population text

Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy.

Inclusion criteria

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

•Male or female, age greater than or equal to 18 years at the time of signing informed consent.

•Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.

•The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

•Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.

•For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.

•The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.

•Available and documented HbA1c measurement no more than 3 months prior to Xultophy® initiation.

Exclusion criteria

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

•Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.

•Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.

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

•Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.

•Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.

Endpoints (11)

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

6 endpoints

Primary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c)

Time frame:From baseline (V0, month 0) to 6 months after initiation.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c levels less than 7% (yes/no)

Time frame:At end of study (V3, 18 ±3 months)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)

Time frame:At end of study (V3, 18 ±3 months)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)

Time frame:At end of study (V3, 18 ±3 months)

categorical status, improvement

componentsaddition of prandial insulin, increase in total insulin dose, increase in number of concomitant oads

Secondary/protocol endpoint/low confidence

Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)

Time frame:At end of study (V3, 18 ±3 months)

categorical status, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection

Time frame:Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection

Time frame:Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection

Time frame:Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit

Severe hypoglycemia

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Reason for switching to Xultophy® (precoded question list)

Time frame:At baseline (V0, month 0)

descriptive

Secondary/protocol endpoint/low confidence

Change in Xultophy® daily dose

Time frame:From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

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.