Treat-to-Target Trial of Basal Insulin in Post-Transplant Hyperglycemia - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00830297

Purpose

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

ACRONYM:

TIP

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 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®), in comparison to patients under conventional post-transplant blood-glucose lowering therapy, on day 10 post-transplant, as measured by a continuous glucose monitoring device (Medtronic)
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 (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 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 <72 mg/dl (4 mmol/))
To assess the incidence of post-transplant diabetes, as diagnosed by an abnormal oral glucose tolerance on days 90 and 180 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 II

MedlinePlus related topics: Hypoglycemia Kidney Transplantation

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 and day 180 ] [ 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 >250 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 <72 mg/dl (4 mmol/l) 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 and 180 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Insulatard (long-acting insulin): Active Comparator	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 90 to 140 mg/dl.
2 Conventional treatment: Active Comparator	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 proposed to be used for corrections of capillary blood glucose levels above 250 mg/dl.

Arms

Assigned Interventions

1 Insulatard (long-acting insulin): Active Comparator

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 90 to 140 mg/dl.

2 Conventional treatment: Active Comparator

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 proposed to be used for corrections of capillary blood glucose levels above 250 mg/dl.

Show Detailed Description

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, prednisone triple therapy without induction
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

Contacts

Contact: Marcus D Säemann, MD	+431404005593	marcus.saemann@meduniwien.ac.at
Contact: Manfred Hecking, MD	+431404005593	manfred.hecking@meduniwien.ac.at

Locations

Austria
Medical University of Vienna, Department of Internal Medicine III	Recruiting
Vienna, Austria, 1090
Sub-Investigator: Manfred Hecking, MD
Principal Investigator: Marcus D Säemann, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Study Chair:

Wilfred Druml, MD

Medical University of Vienna

More Information

Publications:

Davidson JA, Wilkinson A; International Expert Panel on New-Onset Diabetes after Transplantation. New-Onset Diabetes After Transplantation 2003 International Consensus Guidelines: an endocrinologist's view. Diabetes Care. 2004 Mar;27(3):805-12. No abstract available.

Responsible Party:	Medical University of Vienna ( Prof. Dr.Dr. Walter Hörl )
Study ID Numbers:	EudraCT: 2008-005951-84
Study First Received:	January 26, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00830297 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

NODAT
hyperglycemia
long-acting insulin
post-transplant hyperglycemia

Study placed in the following topic categories:

Insulin, Long-Acting
Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Gliclazide

Tacrolimus
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Insulin, Long-Acting
Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia

Physiological Effects of Drugs
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009