drugset / Trial / NCT01346254

Glucose Control in Pre-Diabetic Renal Transplant Patients

NCT01346254

Phase 2 Completed 51 enrolled Marcus Saemann
RandomizedParallel-groupTriple-blindTreatment

Summary

Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system. It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes. This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months. The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.

Timeline

Start
2009-12
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 30 mg Oral
Subject Vildagliptin Other / unclassified 50 mg Oral

Indications