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Sitagliptin in Renal Transplant Recipients

NCT ID: NCT00740363

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glucose Intolerance

Keywords

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renal transplantation diabetes glucose intolerance impaired glucose tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Patients will receive 4 weeks of treatment with sitagliptin once daily

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

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

No treatment for 4 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

No active sitagliptin treatment for 4 weeks

Interventions

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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

Intervention Type DRUG

placebo

No active sitagliptin treatment for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Januvia

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo School of Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trond Jenssen, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet Medical Center

Locations

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Rikshospitalet Medical Center

Oslo, , Norway

Site Status

Countries

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Norway

References

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Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

Reference Type DERIVED
PMID: 32803882 (View on PubMed)

Other Identifiers

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JANUVIA-08

Identifier Type: -

Identifier Source: org_study_id