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

NCT ID: NCT05443334

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

465 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-28

Study Completion Date

2024-07-04

Brief Summary

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The purpose of the study is to collect information on participant's blood sugar levels, body weight, how satisfied participant is with the treatment, and how participant takes his/her diabetes medicines. Participant will get Rybelsus® as prescribed by study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with type 2 diabetes

Participants with type 2 diabetes and naive to injectable glucose-lowering treatment.

Semaglutide

Intervention Type DRUG

Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the participant in this study.

Interventions

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Semaglutide

Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the participant in this study.

Intervention Type DRUG

Eligibility Criteria

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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)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than 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
* Treatment naive to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days

Exclusion Criteria

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Master Centre for Spain

Barcelona, , Spain

Site Status

Master Centre for Spain

Madrid, , Spain

Site Status

Countries

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Spain

References

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Delgado Alvarez E, Morales Portillo C, Abreu Padin C, Aliaga Verdugo A, Piera Carbonell A, Cadenas Gonzalez A, Amor Valero J, Gonzalez Lopez V, Rasmussen CL, Scheuer SH, Bellido Guerrero D. PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes. Diabetes Obes Metab. 2025 Sep;27(9):4812-4824. doi: 10.1111/dom.16523. Epub 2025 Jun 24.

Reference Type DERIVED
PMID: 40555703 (View on PubMed)

Other Identifiers

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U1111-1240-4149

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4547

Identifier Type: -

Identifier Source: org_study_id

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