NCT01346254

Glucose Control in Pre-Diabetic Renal Transplant Patients

Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Marcus Saemann · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impaired Glucose Tolerance
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Vildagliptin	50mg tablets once daily 20 min before breakfast for 3 months
DRUG	Pioglitazone	30mg tablets once daily 20 min before breakfast for 3 months
BEHAVIORAL	Life-Style Modification	All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-05-02
• Last updated: 2011-12-05

Locations

1 site across 1 country: Austria