NCT00740363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

August 21, 2008

Last Update Submit

September 21, 2012

Conditions

Glucose Intolerance

Keywords

renal transplantationdiabetesglucose intoleranceimpaired glucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Insulin secretion

    4 weeks

Secondary Outcomes (4)

  • Insulin sensitivity

    4 weeks

  • Fasting blood glucose

    4 weeks

  • Endothelial function

    4 weeks

  • Cyclosporine/tacrolimus blood concentrations

    4 weeks

Study Arms (2)

A

EXPERIMENTAL

Patients will receive 4 weeks of treatment with sitagliptin once daily

Drug: sitagliptin

B

PLACEBO COMPARATOR

No treatment for 4 weeks

Drug: placebo

Interventions

sitagliptinDRUG

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

Also known as: Januvia
A
placeboDRUG

No active sitagliptin treatment for 4 weeks

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet Medical Center

Oslo, 0027, Norway

Location

Related Publications (1)

  • 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.

    PMID: 32803882DERIVED

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Trond Jenssen, MD, Professor

    Rikshospitalet Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2008

First Posted

August 25, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

NO(1)