drugset / Trial / NCT03507829
Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients
Phase 3
Completed
263 enrolled
Medical University of Vienna
Charite University, Berlin, Germany · collabHospital del Mar · collabMedical University of Graz · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to assess the effects of early basal insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.The ITP NODAT study should be seen in connection with the Vienna SAPT-NODAT study (clinicaltrials.gov record number: NCT01680185), as for the final analysis, the data yielded from the three arms in those two studies will be used for an pooled analysis.
Timeline
- Start
- 2012-11-21
- Primary completion
- 2018-05-22
- Completion
- 2018-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Human insulin isophane | Unknown | 10 iu | — |
| Comparator | Human insulin isophane | Unknown | 12 iu | — |
| Comparator | Human insulin isophane | Unknown | 14 iu | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |