Skip to main content
OpenTrials
Completed

NCT Number: NCT00740363

Sitagliptin in Renal Transplant Recipients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rikshospitalet Medical Center

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal transplant recipient more than 1 year posttransplant with stable renal function (less than 20% deviation in serum creatinine the last 2 months) and stable prednisolone dose for the last 3 months before inclusion.
  • Patients in need of (additional) oral anti-diabetic treatment:
  • New onset diabetes patients with fasting plasma glucose 7-8 mmol/ l, and/or 2-hr plasma glucose 12-18 mmol/l after an oral glucose tolerance test (OGTT)
  • Patients already on oral hypoglycemic therapy, but with HbA1c 8-11%
  • 18 years of age.
  • Male patient, or female patient without childbearing potential (surgically sterilized or postmenopausal) or, if female of childbearing potential, is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 Days following discontinuation of the Study Drugs.
  • Signed informed consent.

Exclusion criteria

  • Treatment with insulin
  • Severe liver disease.
  • Estimated GFR < 25 ml/min/1.73 m2.
  • Skin disorders that may influence laser Doppler flowmetry investigations.
  • Pregnant or nursing mothers.

Treatment and study plan

Sitagliptin

Drug

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

Other names: Januvia

Placebo

Drug

No active sitagliptin treatment for 4 weeks

Primary outcomes

  1. Insulin secretion

    Time frame: 4 weeks

Secondary outcomes

  1. Insulin sensitivity

    Time frame: 4 weeks

  2. Fasting blood glucose

    Time frame: 4 weeks

  3. Endothelial function

    Time frame: 4 weeks

  4. Cyclosporine/tacrolimus blood concentrations

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2008
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.