A

Phase 1

• Conditions: Previously non-diabetic end stage renal disease patients undergoing kidney transplantation.; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2012-000225-51-ES
• Lead Sponsor: Fundació Institut Mar d'investigacions Mediques

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 380

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, mycophenolate mofetil or mycophenolic sodium and steroids.
4.Capable of understanding the study and willing to give informed written consent for study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 380

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.
2Patients 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims to assess the effects of early 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.;Secondary Objective: 1.To determine the improvement in overall glycemic control among patients managed with the early initiation of insulin therapy compared to standard of care management in patients experiencing abnormal glucose metabolism.<br>2.To determine the improvement in ß-cell function among patients assigned to the early initiation of insulin therapy compared to the standard of care management in patients experiencing abnormal glucose metabolism.;Primary end point(s): The incidence of NODAT 12 months after kidney transplantation defined according to American Diabetes Association criteria.;Timepoint(s) of evaluation of this end point: 12 Months