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Sitagliptin in Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00740363
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : September 25, 2012
Oslo University Hospital
Information provided by (Responsible Party):
University of Oslo School of Pharmacy

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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Drug: sitagliptin Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08
Study Start Date : September 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Insulin secretion [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 4 weeks ]
  2. Fasting blood glucose [ Time Frame: 4 weeks ]
  3. Endothelial function [ Time Frame: 4 weeks ]
  4. Cyclosporine/tacrolimus blood concentrations [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00740363

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Rikshospitalet Medical Center
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Oslo University Hospital
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Principal Investigator: Trond Jenssen, MD, Professor Rikshospitalet Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Oslo School of Pharmacy Identifier: NCT00740363    
Other Study ID Numbers: JANUVIA-08
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012
Keywords provided by University of Oslo School of Pharmacy:
renal transplantation
glucose intolerance
impaired glucose tolerance
Additional relevant MeSH terms:
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Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action