Sitagliptin in Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00740363
First received: August 21, 2008
Last updated: September 21, 2012
Last verified: September 2012

August 21, 2008
September 21, 2012
September 2008
June 2012   (final data collection date for primary outcome measure)
Insulin secretion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00740363 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Fasting blood glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Cyclosporine/tacrolimus blood concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sitagliptin in Renal Transplant Recipients
The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Glucose Intolerance
  • 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
    Other Name: Januvia
  • Drug: placebo
    No active sitagliptin treatment for 4 weeks
  • Experimental: A
    Patients will receive 4 weeks of treatment with sitagliptin once daily
    Intervention: Drug: sitagliptin
  • Placebo Comparator: B
    No treatment for 4 weeks
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00740363
JANUVIA-08
No
University of Oslo School of Pharmacy
University of Oslo School of Pharmacy
Oslo University Hospital
Principal Investigator: Trond Jenssen, MD, Professor Rikshospitalet Medical Center
University of Oslo School of Pharmacy
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP