Sitagliptin in Renal Transplant Recipients

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740363
• Other study ID #: JANUVIA-08
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2008
• Last updated: September 21, 2012
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

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
• placebo
No active sitagliptin treatment for 4 weeks

Locations

Country	Name	City	State
Norway	Rikshospitalet Medical Center	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion		4 weeks	No
Secondary	Insulin sensitivity		4 weeks	No
Secondary	Fasting blood glucose		4 weeks	No
Secondary	Endothelial function		4 weeks	No
Secondary	Cyclosporine/tacrolimus blood concentrations		4 weeks	Yes