- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00740363
Sitagliptin in Renal Transplant Recipients
The Effect of Sitagliptin Treatment on Glucose Metabolism and Endothelial Function in Renal Transplant Recipients - JANUVIA-08
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Oslo, Norge, 0027
- Rikshospitalet Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: A
Patients will receive 4 weeks of treatment with sitagliptin once daily
|
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
Andre navne:
|
|
Placebo komparator: B
No treatment for 4 weeks
|
No active sitagliptin treatment for 4 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Insulin secretion
Tidsramme: 4 weeks
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Insulinfølsomhed
Tidsramme: 4 uger
|
4 uger
|
|
Fastende blodsukker
Tidsramme: 4 uger
|
4 uger
|
|
Endothelial function
Tidsramme: 4 weeks
|
4 weeks
|
|
Cyclosporine/tacrolimus blood concentrations
Tidsramme: 4 weeks
|
4 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Trond Jenssen, MD, Professor, Rikshospitalet Medical Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Hyperglykæmi
- Glucoseintolerance
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Sitagliptin fosfat
Andre undersøgelses-id-numre
- JANUVIA-08
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