NCT00740363

Sitagliptin in Renal Transplant Recipients

The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Oslo School of Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The major cause of premature death in renal transplant recipients is cardiovascular disease. Sitagliptin stimulates insulin secretion and inhibits glucagon release, two central mechanisms in PTDM by interaction with a hormone system (incretins) that just recently it has become possible to modulate by drugs. Sitagliptin therefore is an interesting additional drug for the treatment of posttransplant diabetes mellitus in transplanted patients. The primary objective of the present study is to investigate the effect of sitagliptin on insulin secretion in renal transplant recipients. Secondary objectives are to study the effect on insulin sensitivity, fasting blood glucose, endothelial function, CsA/Tac blood concentrations.

Conditions

• Glucose Intolerance

Interventions

Type	Name	Description
DRUG	sitagliptin	Once daily sitagliptin. If GFR\>50 ml/min/1.73m2: 100 mg/day. If GFR from 25 to 49 ml/min/1.3m2: 50 mg/day
DRUG	placebo	No active sitagliptin treatment for 4 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-08-25
• Last updated: 2012-09-25

Locations

1 site across 1 country: Norway