drugset / Trial / NCT02823808
Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function
Phase 4
Unknown
96 enrolled
Kyunghee University Medical Center
Ajou University School of Medicine · collabBucheon St. Mary's Hospital · collabInha University Hospital · collabKangbuk Samsung Hospital · collabKorea University Guro Hospital · collabKyung Hee University Hospital at Gangdong · collabSeoul Medical Center · collabTakeda · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol. * All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks. * Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.
Timeline
- Start
- 2017-07
- Primary completion
- 2021-07
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alogliptin | Unknown | 25 mg | — |
| Comparator | Glimepiride | Small molecule | 2 mg | — |
| Comparator | Metformin | Small molecule | 500 mg | — |
| Subject | Pioglitazone | Small molecule | 15 mg | — |