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Sitagliptin in Renal Transplant Recipients

NCT00740363 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-09-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Trond Jenssen, MD, Professor · Rikshospitalet Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00740363 on ClinicalTrials.gov