Clinical trial NCT00740363: Sitagliptin in Renal Transplant Recipients
Official title: The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glucose Intolerance
Keywords: renal transplantation
diabetes
glucose intolerance
impaired glucose tolerance
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2008-08-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin secretion
timeFrame: 4 weeks
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 4 weeks
measure: Fasting blood glucose
timeFrame: 4 weeks
measure: Endothelial function
timeFrame: 4 weeks
measure: Cyclosporine/tacrolimus blood concentrations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet Medical Center
Study officials:
affiliation: Rikshospitalet Medical Center
name: Trond Jenssen, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.