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Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients

NCT03507829 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2019-02-19

No results posted yet for this study

Summary

This study aims to assess the effects of early basal insulin therapy in previously non-diabetic de novo kidney transplant patients in reducing the incidence of new onset diabetes in particular and abnormal glucose metabolism in general during subsequent follow-up.The ITP NODAT study should be seen in connection with the Vienna SAPT-NODAT study (clinicaltrials.gov record number: NCT01680185), as for the final analysis, the data yielded from the three arms in those two studies will be used for an pooled analysis.

Conditions

Interventions

DRUG

Human insulin isophane, Humulin N (Eli Lilly)

Human insulin isophane, Humulin N (Eli Lilly)

DRUG

Standard of care

Sliding scale short acting insulin for hyperglycemia; Sulphonylurea for NODAT

DRUG

Insulin lispro, Humalog (Eli Lilly) in insulin pump

Insulin lispro, Humalog (Eli Lilly) in insulin pump

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • Hospital del Mar

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Manfred Hecking, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-21
Primary Completion
2018-05-22
Completion
2018-05-22

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507829 on ClinicalTrials.gov