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

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171743

Purpose

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 IV

MedlinePlus related topics: Diabetes Liver Transplantation

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Switch From Tacrolimus to Cyclosporine Microemulsion: Immunosuppressive Agents and Diabetes Management in Liver Transplant Recipients in Maintenance (DIALIVER)

Further study details as provided by Novartis:

Study Start Date:

April 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171743

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	COLO400AIT03
Study First Received:	September 13, 2005
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00171743
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Novartis:

Adults
Post transplant diabetes

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole

Diabetes Mellitus
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009