drugset / Trial / NCT06082063
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Phase 3
Recruiting
2000 enrolled
Steno Diabetes Center Copenhagen
Aarhus University Hospital · collabBispebjerg Hospital · collabEsbjerg Hospital - University Hospital of Southern Denmark · collabHerning Hospital · collabHillerod Hospital, Denmark · collabHvidovre University Hospital · collabNykøbing Falster County Hospital · collabRanders Regional Hospital · collabRegionshospitalet Horsens · collabRegionshospitalet Silkeborg · collabRegionshospitalet Viborg, Skive · collabRigshospitalet, Denmark · collabSlagelse Hospital · collabSteno Diabetes Center Nordjylland · collabSteno Diabetes Center Odense · collabZealand University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.
Timeline
- Start
- 2024-07-01
- Primary completion
- 2029-07-01
- Completion
- 2029-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 75 mg | — |
| Comparator | Finerenone | Small molecule | 20 mg | — |
| Comparator | Semaglutide | Peptide | 1 mg | — |
| Comparator | Sotagliflozin | Small molecule | 200 mg | — |
| Comparator | Clopidogrel | Small molecule | — | — |