Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia (TIP)
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ClinicalTrials.gov Identifier: NCT00830297 |
Recruitment Status
:
Completed
First Posted
: January 27, 2009
Last Update Posted
: September 3, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | January 26, 2009 | |||
First Posted Date ICMJE | January 27, 2009 | |||
Last Update Posted Date | September 3, 2012 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The primary endpoint is the difference in HbA1c between the two study arms. [ Time Frame: post-transplant day 90 ] | |||
Original Primary Outcome Measures ICMJE |
The primary endpoint is the difference in HbA1c between the two study arms. [ Time Frame: post-transplant day 90 and day 180 ] | |||
Change History | Complete list of historical versions of study NCT00830297 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia | |||
Official Title ICMJE | 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 | |||
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:
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Detailed Description | 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 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 three times daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl. EFFICACY ENDPOINTS: Primary: - HbA1c levels Secondary:
TOLERABILITY / SAFETY ENDPOINTS: - Number of incidences of symptomatic hypoglycemia, confirmed by capillary blood glucose levels < 60 mg/dl PHARMACOKINETIC / PHARMACODYNAMIC ENDPOINTS: Doses of (long-acting) insulin STATISTICAL METHODOLOGY: Primary Endpoint: HbA1c (rel %) Null and alternative hypotheses: H0 Treatment of hyperglycemia > 140 mg/dl before supper with long-acting insulin in renal transplant recipients for a period of at least 14 days after transplantation is equal to conventional treatment in reducing the HbA1c (measured on day 90 after transplantation). H1: Treatment of hyperglycemia > 140 mg/dl before supper with long-acting insulin in renal transplant recipients for a period of at least 14 days after transplantation is superior to conventional treatment in reducing the HbA1c (measured on day 90 after transplantation). Type-I and -II errors - power: α=0.05 ß=0.2 Statistical methodology: One-sided t-test of HbA1c on day 90 after transplantation, one-sided t-test of number of days with hyperglycemia > 140 mg/dl before supper, comparison of capillary blood glucose levels by ANOVA Sample size calculation: Based on a two-sided testing and an expected standard deviation of HbA1c of 10%, an α=0.05 and a ß=0.2, a sample size of 25 patients per group was determined. Main analysis set: Per-protocol (efficacy) and intention to treat (ITT) for safety Other endpoints: descriptive statistics |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hyperglycemia | |||
Intervention ICMJE |
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Study Arms |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
50 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | May 2011 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00830297 | |||
Other Study ID Numbers ICMJE | EudraCT: 2008-005951-84 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Marcus Saemann, Medical University of Vienna | |||
Study Sponsor ICMJE | Marcus Saemann | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medical University of Vienna | |||
Verification Date | August 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |