The medical condition to be investigated is post-transplant hyperglycemia in renal transplant recipients.
Conditions
Interventions
Trade Name: Insulatard®
Product Name: Insulatard®
Pharmaceutical Form: Solution for injection
CAS Number: 11061-68-0
Other descriptive name: human insulin
Concentration unit: IU international unit(s)
Sponsors
Medizinische Universität Wien, KIM III, Abteilung für Nephrologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Renal transplantation and immunosuppression with the standard protocol of our center (tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction therapy) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any history of Diabetes Mellitus is an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the superiority of long-acting insulin (Insulatard®) against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c as well as repeated measures of capillary blood glucose levels.;Secondary Objective: • To assess the average post-transplant glucose levels in renal transplant patients under conventional blood-glucose lowering therapy during a period of at least 14 days after transplantation by measuring the capillary blood glucose levels three times daily in both groups of patients (at 8:00, 14:00, 16:00) • To assess a full 48h glucose profile in patients treated with long-acting insulin (Insulatard®) • To detect the average number of hyperglycemic episodes in post-transplant patients • To assess the amount of long-acting insulin (Insulatard®,in units) needed in order to obtain a target capillary blood glucose level in the range of 90 mg/dl to 140 mg/dl before supper • To assess the safety of long-acting insulin in controlling post-transplant hyperglycemia • To assess the incidence of post-transplant diabetes • To assess the morbidity • To assess the renal outcome (creatinine levels, rejections) ;Primary end point(s): The primary endpoint is the difference in HbA1c between the two study arms. | — |
Countries
Austria
Outcome results
None listed