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Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia (TIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcus Saemann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00830297
First received: January 26, 2009
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Hyperglycemia
 Drug: Insulatard (long-acting insulin)
Drug: Conventional
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Tacrolimus-based Immunosuppression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • The primary endpoint is the difference in HbA1c between the two study arms. [ Time Frame: post-transplant day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Capillary blood glucose profiles in each group [ Time Frame: post-transplant day 1-21 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of patients and overall number of days with hyperglycemia >200 mg/dl (in each group) [ Time Frame: post-transplant day 1-21 ] [ Designated as safety issue: Yes ]
  • Number of patients and overall number of days with hypoglycemia <60 mg/dl in each group [ Time Frame: post-transplant day 1-21 ] [ Designated as safety issue: Yes ]
  • Number of patients with abnormal glucose tolerance [ Time Frame: post-transplant day 90, 180 and 360 ] [ Designated as safety issue: No ]
  • Difference in HbA1c between the two study arms [ Time Frame: post-transplant day 180 and 360 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Insulatard (long-acting insulin) Drug: Insulatard (long-acting insulin)
In group No.1 (study arm 1 (=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.
Active Comparator: 2 Conventional treatment Drug: Conventional
In group No.2 (study arm 2 (=B)), patients will be treated conventionally according to the decisions taken by the physicians on the ward. The following suggestions will be brought to the attention of the ward in order to standardize the treatment of the patients in study arm B: 1. Treatment in this group should be initiated if the fasting glucose level surpasses the renal glucose threshold, i.e. 180 mg/dl. 2. As the proposed life-style modifications for the treatment of NODAT1 are not feasible during this very early post-transplant phase, the basis of the conventional therapy will be proposed to be sulfonyl urea drugs (i.e. Gliclazide - Diamicron®, 30 mg, not more than twice daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • renal transplantation (deceased or living donor)
  • eligibility for the standard immunosuppression of our center, consisting of tacrolimus, mycophenolate mofetil or mycophenolic acid, dexamethasone/prednisone triple therapy
  • informed consent of the patient

Exclusion Criteria:

  • patients with type 1 or type 2 diabetes
  • allergy against long-acting insulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830297

Locations
Austria
Medical University of Vienna, Department of Internal Medicine III
Vienna, Austria, 1090
Sponsors and Collaborators
Marcus Saemann
Investigators
Study Chair: Wilfred Druml, MD Medical University of Vienna
  More Information

Publications:

Responsible Party: Marcus Saemann, Ass. Prof. Dr. Marcus Säemann, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00830297     History of Changes
Other Study ID Numbers: EudraCT: 2008-005951-84
Study First Received: January 26, 2009
Last Updated: August 30, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
TIP
NODAT
hyperglycemia
long-acting insulin
post-transplant hyperglycemia

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, NPH
 Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 18, 2012