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SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)

25. marts 2018 opdateret af: Kazuomi Kario, Jichi Medical University
To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study consists of a 8-week run-in period and a 12-week treatment period.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

174

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Fukuoka, Japan
        • Fukuoka University Chikushi Hospital
      • Fukuoka, Japan
        • Kotake Hospital
      • Fukuoka, Japan
        • Onga Hospital
      • Gifu, Japan
        • Ishiguro Clinic
      • Gunma, Japan
        • Higashiagatsuma-machi National Health Insurance Clinic
      • Hyogo, Japan
        • Katsuya Iin
      • Miyagi, Japan
        • Minamisanriku Hospital
      • Saitama, Japan
        • Shibuya Clinic
      • Tochigi, Japan
        • Jichi Medical University Hospital
      • Tochigi, Japan
        • International University of Health and welfare Hospital
      • Tochigi, Japan
        • Utsunomiya higashi hospital
      • Tokyo, Japan
        • Kato Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Patients who meet the following criteria at the start of treatment are eligible for the study:

  • Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W).
  • Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W).
  • HbA1c>=6.0%, <10%
  • Seated office SBP 130-159mmHg or DBP 80-99mmHg
  • Nocturnal hypertension (SBP>=115 mmHg) as measured by Home BP during 5days before baseline (0W).
  • Age>=20

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

  • History of hypersensitivity to empagliflozin
  • Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
  • Treated with insulin or SU
  • With renal dysfunction (eGFR<45mL/min/1.73m2)
  • With liver dysfunction (AST or ALT is 3 times higher than reference value)
  • Hypotension (systolic blood pressure < 90 mmHg)
  • With pituitary gland dysfunction or adrenal gland dysfunction
  • Heart failure patients whose NYHA class is IV
  • Deemed ineligible for the study due to another reason by investigator
  • History of diabetic ketoacidosis or diabetic come within 3 months before enrollment
  • History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment
  • Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment
  • Patients received SGLT2 inhibitor within 8 weeks before enrollment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Empagliflozin
Empagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
Medicin: Empagliflozin
Empagliflozin 10mg/day once daily before or after breakfast
Andre navne:
  • Jardiance
Placebo komparator: Placebo
Placebo is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
Medicin: Placebo
Placebo once daily before or after breakfast

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Reduction of nocturnal blood pressure measured by ABPM
Tidsramme: 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Reduction of Blood pressure measured by ABPM -24h Blood Pressure
Tidsramme: 12 weeks
12 weeks
Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure
Tidsramme: 12 weeks
12 weeks
Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure
Tidsramme: 12 weeks
12 weeks
Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -HbA1c
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -body weight
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -BMI
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -lipids
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -uric acid
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -HOMA-R
Tidsramme: 12 weeks
12 weeks
Reduction of Metabolism-related factors -HOMA-beta
Tidsramme: 12 weeks
12 weeks
Change in Sleep efficacy -Sleep scale (Athens insomnia scale)
Tidsramme: 12 weeks
12 weeks
Change in Sleep efficacy -Frequency of nocturnal awakening
Tidsramme: 12 weeks
12 weeks
Change in Sleep efficacy -Frequency of nocturia
Tidsramme: 12 weeks
12 weeks
Changes in the measures of circulating volume -Plasma NT-proBNP
Tidsramme: 12 weeks
12 weeks
Changes in the measures of circulating volume -ANP
Tidsramme: 12 weeks
12 weeks
Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio
Tidsramme: 12 weeks
12 weeks
Changes in the measures of organ damage -Urinary Na/K
Tidsramme: 12 weeks
12 weeks
Changes in the measures of organ damage -eGFR
Tidsramme: 12 weeks
12 weeks
Changes in the measures of organ damage -cystatinC
Tidsramme: 12 weeks
12 weeks
The correlation between blood pressure and blood glucose control
Tidsramme: 12 weeks
12 weeks
The correlation between blood pressure and body weight
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jichi Medical University

Samarbejdspartnere

Eli Lilly and Company
Boehringer Ingelheim

Efterforskere

  • Ledende efterforsker: Kazuomi Kario, MD, Jichi Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. oktober 2017

Studieafslutning (Faktiske)

1. marts 2018

Datoer for studieregistrering

Først indsendt

26. december 2016

Først indsendt, der opfyldte QC-kriterier

8. februar 2017

Først opslået (Faktiske)

10. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1245-131

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med T2DM (Type 2 Diabetes Mellitus)

Kliniske forsøg med Empagliflozin

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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