Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
Treat-to-target trial of basal Insulin in Post-transplant hyperglycemia (TIP): efficacy and
safety of a novel protocol in renal transplant recipients receiving a tacrolimus-based
immunosuppression
DESCRIPTION:
A prospective, randomized safety and efficacy study of long-acting insulin (Insulatard®) as
therapy against post-transplant hyperglycemia in renal transplant recipients
OBJECTIVES:
Primary Objective:
To demonstrate superiority of long-acting insulin (Insulatard®) against post-transplant
hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c
Secondary Objectives:
- 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 four times daily in both
groups of patients (fasting, before lunch, before supper, after supper)
- To detect the number of post-transplant patients who - without any history of
pre-transplant diabetes - develop at least one episode of post-transplant hyperglycemia
(> 140 mg/dl before supper)
- To detect the average number of hyperglycemic episodes in post-transplant patients with
at least one episode of post-transplant hyperglycemia and without any history of
diabetes
- To assess the amount of (long-acting) insulin (in IU) needed in order to obtain a target
capillary blood glucose level in the range of 110 mg/dl to 120 mg/dl before supper in
post-transplant patients with incidence of hyperglycemia
- To assess the safety of long-acting insulin in controlling post-transplant hyperglycemia
(especially with regards to episodes of hypoglycemia (glucose-level < 60 mg/dl)
- To assess the prevalence of post-transplant diabetes, as diagnosed by an abnormal oral
glucose tolerance on days 90, 180 and 360 after transplantation, in the group of
patients which has been treated with long-acting insulin, in comparison to patients who
received conventional treatment
- To assess the morbidity (hospitalization, infections, subsequent episodes of surgery,
requirement of non-immunosuppressive, non- blood glucose lowering medication) in the
group of patients with long-acting insulin for hyperglycemia, in comparison to patients
randomized into the group receiving conventional treatment
- To assess the renal outcome (creatinine levels, rejections) in the group of patients
which is foreseen to be treated with long-acting insulin for hyperglycemia, in
comparison to patients randomized into the group receiving conventional treatment