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The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine - cyclosporine microemulsion | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment). | ||
| % of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion. |
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Inclusion Criteria:
Exclusion Criteria
Other protocol-defined inclusion / exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21530445 | Derived | Lorho R, Hardwigsen J, Dumortier J, Pageaux GP, Durand F, Bizollon T, Blanc AS, Di Giambattista F, Duvoux C. Regression of new-onset diabetes mellitus after conversion from tacrolimus to cyclosporine in liver transplant patients: results of a pilot study. Clin Res Hepatol Gastroenterol. 2011 Jun;35(6-7):482-8. doi: 10.1016/j.clinre.2011.03.008. Epub 2011 May 6. |
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| % of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion. |
| Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values, |
| % of patients receiving antihypertensive treatment), |
| BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year. |
| Incidence of acute and chronic rejection treated at 6 months and at 1 year. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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