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NCT05353686
A Trial Investigating the Effect of 4 Weeks Dosing of XEN-D0501 on Blood Glucose Reduction in Patients With Diabetes
Phase 2 trial testing Placebo in Efficacy in 54 participants. Completed in 19 December 2019.
19 December 2019
Quick facts
| Lead sponsor | Pila Pharma |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 25 February 2019 |
| Primary completion | 19 December 2019 |
| Estimated completion | 19 December 2019 |
| Sites | 10 locations across Lithuania |
Drugs / interventions tested
- Placebo
- XEN-D0501 — full drug profile →
Conditions studied
- Efficacy — all drugs for Efficacy →
- Safety — all drugs for Safety →
- Pharmacokinetics — all drugs for Pharmacokinetics →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Pila Pharma — full company profile →
Who can join
25 and older, any sex, with Efficacy or Safety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
TRPV1 Receptor Modulators: Emerging Therapies for Neuropathic, Osteoarthritic, and Perioperative Pain.
Tsai EH, Gan TJ. · · 2026 · PMID 41722000 · DOI 10.1007/s40263-026-01272-1
Verify or expand the search:
- PubMed search for NCT05353686
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Pila Pharma trials
Trials by the same sponsor.
- NCT03278158 — A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2 · Phase 2 · completed
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 NCT05353686 (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 Pila Pharma
- Last refreshed: 29 April 2022
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/NCT05353686.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing