Sitagliptin in Renal Transplant Recipients
This study has been completed.
Sponsor:
University of Oslo School of Pharmacy
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
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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
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 June 18, 2013