Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2018-05-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: Charite University, Berlin, Germany; Hospital del Mar; Medical University of Graz
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

1. Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.

2. Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose < 126 mg/dl).

3. Receiving standard triple immunosuppressive medications that include tacrolimus (once-daily in Europe, twice-daily in the U.S.), mycophenolate mofetil or mycophenolic sodium and steroids.

4. Capable of understanding the study and willing to give informed written consent for study participation.

Exclusion Criteria:

1. Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart.

2. Patients receiving an organ transplant other than kidney.

3. Patients receiving an unlicensed drug or therapy within one month prior to study entry.

4. Patients with history of hypersensitivity to injectable insulin.

5. Patients with documented HIV infection.