GLP-1 Peptide Atlas, by Delfa

Withdrawn

A Research Study in Italy to Understand How the Dose Check App Used With Xultophy® Works in the Treatment of People Living With Type 2 Diabetes

A Multi-centre, Prospective, Single-arm, Non-interventional Study Describing the Use of the Dose Check App in People Living With Type 2 Diabetes Mellitus and Treated With IDegLira in a Real-world Setting in Italy

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤12%

Primary endpoint

•Participant downloaded and actively used the app (Yes/No)

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 IDNCT06113341

Org study IDNN9068-7589

Secondary IDU1111-1288-8131World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-11-02actual

Last update posted2024-10-01actual

Study start2024-11-07estimated

Primary completion2025-02-23estimated

Study completion2026-03-02estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

The study population will consist of participants diagnosed with T2DM greater than or equal to (\>=) 12 weeks and aged \>=21 years at the time of signing informed consent.

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).

•Male or female, age above or equal to 21 years at the time of signing informed consent.

•Diagnosed with T2DM >=12 weeks prior to signing consent.

•The decision to initiate treatment with commercially available Dose Check app as a part of treatment along with Xultophy® as per the local label has been made by the patient and the treating physician before and independently from the decision to include the participant in this study.

•Participants who are insulin naive (including the following situations:

i.already on treatment with Xultophy® at V1 for less than or equal to (<=) 12 months and for <= 15 dose steps and

ii.short-term insulin use for acute illness for a total of <14 days)

•Available HbA1c value <=12 weeks prior to the 'Informed consent and initiation of Dose Check app visit' (V1) or HbA1c measurement taken in relation with the 'Informed consent and initiation of Dose Check app visit' (V1), if in line with local clinical practice.

•Willingness to continue using the Dose Check app on a compatible smartphone according to the intended use for the entire duration of the study.

Exclusion criteria

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

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

•Treatment with any investigational drug or software as a medical device (SaMD) within 30 days prior to enrolment into the study.

•Diagnosed with type 1 diabetes mellitus.

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

•Hypersensitivity to the active substance or any of the excipients as specified in the Xultophy® local label.

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

Other clinical outcomes

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to EOS visit (week 26)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants reaching individual HbA1c target set by physician

Time frame:At EOS visit (week 26)

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants reaching physician set individual fasting blood glucose (FBG) target

Time frame:From baseline (week 0) to EOS visit (week 26)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Time to physician set individual FBG target from first reported FBG

Time frame:From baseline (week 0) to EOS visit (week 26)

time to event, improvement

Secondary/protocol endpoint

Participants achieving target level FBG according to clinical guidance

Time frame:From baseline (week 0) to EOS visit (week 26)

Fasting glucose, change

threshold achievement, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in laboratory measured FPG

Time frame:From baseline (week 0) to EOS visit (week 26)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Participant downloaded and actively used the app (Yes/No)

Time frame:From baseline (week 0) to end of the study (EOS) visit (week 26)

categorical status, 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.