- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02501616
Effect of Dapagliflozine on Systemic and Renal Endothelial Function
Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial)
This is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function.
Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Korea, Republikken, 156-707
- Rekruttering
- Boramae Medical Center
-
Ledende efterforsker:
- Min Kyong Moon
-
Kontakt:
- Bokyung Koo
- E-mail: bokyungkoomd@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
- Treated with diet and exercise alone for recent 3 months
- Aged 20-80 years
- HbA1c 7~9%
This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
- Are not breastfeeding.
- Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
- Intend not to become pregnant during the study.
Exclusion Criteria:
- Previous history of IHD or brain infarct
- Having typical anginal pain or atypical chest pain with dyspnea
- Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
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 |
---|---|
Aktiv komparator: Metformin first
Metformin first 8 wks --> Dapagliflozin 8wks. Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day. |
Andre navne:
|
Aktiv komparator: Dapagliflozin first
Dapagliflozin first 8 wks --> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed. |
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Reactive hyperemic index to measure endothelial function
Tidsramme: 8 weeks
|
endothelial function
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
Tidsramme: 8 week
|
renal tubular injury
|
8 week
|
Urine albumin excretion ratio
Tidsramme: 8 week
|
Urine albumin excretion
|
8 week
|
Urine β2 microglobulin
Tidsramme: 8 week
|
8 week
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Min Kyong Moon, MD PhD, Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BRMH 26-2014-148
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