Sitagliptin in Renal Transplant Recipients - Full Text View

Sponsors and Collaborators:	University of Oslo School of Pharmacy Rikshospitalet HF
Information provided by:	University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:	NCT00740363

Purpose

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.

Condition	Intervention	Phase
Glucose Intolerance	Drug: sitagliptin Drug: placebo	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Dextrose Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08

Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:

Insulin secretion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	14
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Patients will receive 4 weeks of treatment with sitagliptin once daily	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
B: Placebo Comparator No treatment for 4 weeks	Drug: placebo No active sitagliptin treatment for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740363

Contacts

Contact: Anders Åsberg, Ph.D.

+4722856559

anders.asberg@farmasi.uio.no

Locations

Norway
Rikshospitalet Medical Center
Oslo, Norway, 0027

Sponsors and Collaborators

University of Oslo School of Pharmacy

Rikshospitalet HF

Investigators

Principal Investigator:

Trond Jenssen, MD, Professor

Rikshospitalet Medical Center

More Information

Responsible Party:	School of Pharmacy, University of Oslo ( Professor Anders Åsberg )
Study ID Numbers:	JANUVIA-08
Study First Received:	August 21, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740363
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:

renal transplantation
diabetes
glucose intolerance
impaired glucose tolerance

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Glucose Intolerance
Diabetes Mellitus

Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009