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Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 13, 2005
Last updated: June 5, 2017
Last verified: June 2017
The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.

Condition Intervention Phase
Liver Transplant Drug: Cyclosporine microemulsion Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Switch From Tacrolimus to Cyclosporine Microemulsion: Immunosuppressive Agents and Diabetes Management in Liver Transplant Recipients in Maintenance (DIALIVER)

Resource links provided by NLM:

Further study details as provided by Novartis:

Enrollment: 47
Study Start Date: April 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • At least 4 months post-transplant
  • Patients in treatment with tacrolimus
  • Post-transplant diabetes treated with insulin for at least one month

Exclusion Criteria

  • Known hypersensitivity to cyclosporine microemulsion
  • Investigational drug within 60 days before baseline or during the study
  • Patients who cannot comply with the study requirements

Other protocol-defined exclusion criteria applied

  Contacts and Locations
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Please refer to this study by its identifier: NCT00171743

Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceticals Identifier: NCT00171743     History of Changes
Other Study ID Numbers: COLO400AIT03
Study First Received: September 13, 2005
Last Updated: June 5, 2017

Keywords provided by Novartis:
Post transplant diabetes

Additional relevant MeSH terms:
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors processed this record on September 21, 2017