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NCT05443334: PIONEER REAL
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Spain, as Part of Local Clinical Practice
trial testing Semaglutide in Diabetes Mellitus, Type 2 in 465 participants. Completed in 4 July 2024.
4 July 2024
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 465 |
| Start date | 28 July 2022 |
| Primary completion | 4 July 2024 |
| Estimated completion | 4 July 2024 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Semaglutide (semaglutide) — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
PIONEER REAL Spain: A multicentre, prospective, real-world study of oral semaglutide use in adults with type 2 diabetes.
Delgado Álvarez E, Morales Portillo C, Abreu Padín C, Aliaga Verdugo A, et al · · 2025 · cited 4× · PMID 40555703 · DOI 10.1111/dom.16523 -
Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India.
Sanyal D, Saboo B, Phatak SR, Kumar PKM, et al · · 2025 · PMID 41229720 · DOI 10.4103/ijem.ijem_179_25
Verify or expand the search:
- PubMed search for NCT05443334
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM · NA · not yet recruiting
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Novo Nordisk A/S trials
Trials by the same sponsor.
- NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
- NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05443334 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05443334.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing