DelfaGLP-1 Atlas

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PIONEER REAL

Completed

A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice

A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Italy

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

458

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 IDNCT05230615
Org study IDNN9924-4544
Secondary IDU1111-1240-3945World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-02-09actual
Study start2022-04-01actual
Primary completion2023-10-31actual
Study completion2023-10-31actual
Last update posted2025-09-24actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Inclusion criteria

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

2. Diagnosed with type 2 diabetes mellitus

3. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the Specialist based on local label before and independently from the decision to include the patient in this study

4. Male or female, age above or equal to 18 years at the time of signing informed consent

5. Available HbA1c value below or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice

6. Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of below 14 days

Exclusion criteria

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

2. Treatment with any investigational drug within 30 days prior to enrolment into the study

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

Endpoints (8)

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
4
Weight & body composition
2
Patient-reported / QoL
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to End of Study visit (V3) (week 34-44)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight

Time frame:From baseline (week 0) to End of Study visit (V3) (week 34-44)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c (Glycated haemoglobin)

Time frame:From baseline (week 0) to End of Study visit (V3) (week 34-44)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c below 7%

Time frame:End of Study visit (V3) (week 34-44)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 5%

Time frame:From baseline (week 0) to End of Study visit (V3) (week 34-44)

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Secondary/protocol endpoint

HbA1c reduction greater than or equal to 1%-points and body weight reduction of greater than or equal to 3%

Time frame:From baseline (week 0) to End of Study visit (V3) (week 34-44)

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

DTSQc (Diabetes Treatment Satisfaction Questionnaire, change), relative treatment satisfaction

Time frame:End of Study visit (V3) (week 34-44)

change from baseline, improvement

Secondary/protocol endpoint

DTSQs (Diabetes Treatment Satisfaction Questionnaire, status), change in absolute treatment satisfaction From baseline (week 0) to

Time frame:End of Study visit (V3) (week 34-44)

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.