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NCT03867851
Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
Phase 2 trial testing IBsolvMIR in Diabetes Mellitus, Type 1 in 7 participants. Terminated before completion.
13 May 2024
Quick facts
| Lead sponsor | TikoMed AB |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 8 February 2021 |
| Primary completion | 13 May 2024 |
| Estimated completion | 13 May 2024 |
| Sites | 5 locations across Sweden, Netherlands, Norway |
Drugs / interventions tested
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Sponsor
TikoMed AB — full company profile →
Who can join
Adults 18 to 60, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase II open, randomized, active comparator-controlled multi center study in patients with severe type-1 diabetes. This is a two-armed study where patients are randomized in a 2:1 ratio between IBsolvMIR and heparin. Eighteen patients are planned to be included. The study consists of up to 8 visits; screening, transplantation surgery with bolus administration of study drug or active comparator, IBsolvMIR doses on day 1, 3 and 6 after surgery, follow up visits on day 7 and 14, and follow-up phone call on day 44. The primary endpoint is to study AEs up to 44 days following study drug administration. The secondary endpoints are to evaluate changes in TAT, C-peptide, C3a and HGF at baseline and during the first 24 hours after study drug administration, as well as evaluate a change in levels of C-peptide-glucose-creatinine ratio on day 14 compared to baseline.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03867851
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other TikoMed AB trials
Trials by the same sponsor.
- NCT03613571 — A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral Sclerosis · Phase 2 · terminated
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 NCT03867851 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TikoMed AB
- Last refreshed: 16 May 2024
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/NCT03867851.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing