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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08

Resource links provided by NLM:


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 ]

Enrollment: 25
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Other Name: Januvia
Placebo Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
Rikshospitalet Medical Center
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Oslo University Hospital
Investigators
Principal Investigator: Trond Jenssen, MD, Professor Rikshospitalet Medical Center
  More Information

No publications provided

Responsible Party: University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier: NCT00740363     History of Changes
Other Study ID Numbers: JANUVIA-08
Study First Received: August 21, 2008
Last Updated: September 21, 2012
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:
renal transplantation
diabetes
glucose intolerance
impaired glucose tolerance

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014