Clinical Trial: Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Tacrolimu

Brief 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

    Detailed Summary:

    DESIGN / PHASE:

    Prospective, single-center, randomized, parallel group, controlled, phase II study.

    STUDY PLANNED DURATION:

    First patient First visit 1Q 2009 Last patient First visit 4Q 2009 Last patient Last visit 4Q 2010

    CENTERS:

    Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria, Department of Surgery, Division of Transplantation, Medical University of Vienna, Austria

    PATIENTS / GROUPS:

    50 patients in 2 groups 25 patients per group Randomization ratio 1:1, no stratification

    Capillary blood glucose will be measured four times daily: before breakfast (7:30 am), before lunch (12 pm), before supper (5:30 pm) and after supper (9 pm) in both groups by the nursing personnel/academic investigators. In group No.1 (study arm A), patients will be treated with long-acting insulin (Insulatard) as soon as the glucose-level before supper surpasses 140 mg/dl. The normoglycemic goal in this group will be from 110 to 120 mg/dl.

    In group No.2 (study arm B), the glucose levels will be recorded, but the treatment will be left up to the ward, which is relying on conventional morning glucose measurements. For safety, any glucose levels >180 mg/dl will be reported, and all measures taken by the ward will be recorded. As there are no available guidelines however concerning the so called "conventional" blood glucose-lowering therapy in renal transplant patients, especially during this very early post-transplant phase, the followi
    Sponsor: Marcus Saemann

    Current Primary Outcome: The primary endpoint is the difference in HbA1c between the two study arms. [ Time Frame: post-transplant day 90 ]

    Original Primary Outcome: The primary endpoint is the difference in HbA1c between the two study arms. [ Time Frame: post-transplant day 90 and day 180 ]

    Current Secondary Outcome:

    • Capillary blood glucose profiles in each group [ Time Frame: post-transplant day 1-21 ]
    • Number of patients and overall number of days with hyperglycemia >140 mg/dl before supper (in each group) [ Time Frame: post-transplant day 1 - 21 ]
    • Number of patients and overall number of days with hyperglycemia >200 mg/dl (in each group) [ Time Frame: post-transplant day 1-21 ]
    • Number of patients and overall number of days with hypoglycemia <60 mg/dl in each group [ Time Frame: post-transplant day 1-21 ]
    • Number of patients with abnormal glucose tolerance [ Time Frame: post-transplant day 90, 180 and 360 ]
    • Difference in HbA1c between the two study arms [ Time Frame: post-transplant day 180 and 360 ]


    Original Secondary Outcome:

    • Capillary blood glucose profiles in each group [ Time Frame: post-transplant day 1-21 ]
    • Number of patients and overall number of days with hyperglycemia >140 mg/dl before supper (in each group) [ Time Frame: post-transplant day 1 - 21 ]
    • Number of patients and overall number of days with hyperglycemia >250 mg/dl (in each group) [ Time Frame: post-transplant day 1-21 ]
    • Number of patients and overall number of days with hypoglycemia <72 mg/dl (4 mmol/l) in each group [ Time Frame: post-transplant day 1-21 ]
    • Number of patients with abnormal glucose tolerance [ Time Frame: post-transplant day 90 and 180 ]


    Information By: Medical University of Vienna

    Dates:
    Date Received: January 26, 2009
    Date Started: January 2009
    Date Completion:
    Last Updated: August 30, 2012
    Last Verified: August 2012