Status:
COMPLETED
Sitagliptin in Renal Transplant Recipients
Lead Sponsor:
University of Oslo School of Pharmacy
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Glucose Intolerance
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00740363
Start Date
September 1 2008
End Date
June 1 2012
Last Update
September 25 2012
Active Locations (1)
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1
Rikshospitalet Medical Center
Oslo, Norway, 0027