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Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

16. maj 2014 opdateret af: Boehringer Ingelheim

A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

547

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Chiyoda-ku, Tokyo, Japan
        • 1245.38.016 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.38.001 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.38.003 Boehringer Ingelheim Investigational Site
      • Hachioji, Tokyo, Japan
        • 1245.38.002 Boehringer Ingelheim Investigational Site
      • Hanamaki, Iwate, Japan
        • 1245.38.010 Boehringer Ingelheim Investigational Site
      • Kamakura, Kanagawa, Japan
        • 1245.38.005 Boehringer Ingelheim Investigational Site
      • Kanazawa, Ishikawa, Japan
        • 1245.38.020 Boehringer Ingelheim Investigational Site
      • Kashiwa, Chiba, Japan
        • 1245.38.013 Boehringer Ingelheim Investigational Site
      • Katsushika-ku, Tokyo, Japan
        • 1245.38.019 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japan
        • 1245.38.021 Boehringer Ingelheim Investigational Site
      • Matsuyama, Ehime, Japan
        • 1245.38.024 Boehringer Ingelheim Investigational Site
      • Minato-ku, Tokyo, Japan
        • 1245.38.004 Boehringer Ingelheim Investigational Site
      • Moriya, Ibaraki, Japan
        • 1245.38.011 Boehringer Ingelheim Investigational Site
      • Naha, Okinawa, Japan
        • 1245.38.030 Boehringer Ingelheim Investigational Site
      • Okawa, Fukuoka, Japan
        • 1245.38.032 Boehringer Ingelheim Investigational Site
      • Okinawa, Okinawa, Japan
        • 1245.38.031 Boehringer Ingelheim Investigational Site
      • Saga, Saga, Japan
        • 1245.38.025 Boehringer Ingelheim Investigational Site
      • Saitama, Saitama, Japan
        • 1245.38.014 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1245.38.006 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1245.38.007 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1245.38.008 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1245.38.009 Boehringer Ingelheim Investigational Site
      • Sasima-gun, Ibaraki, Japan
        • 1245.38.012 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1245.38.015 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1245.38.018 Boehringer Ingelheim Investigational Site
      • Suginami-ku, Tokyo, Japan
        • 1245.38.017 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1245.38.022 Boehringer Ingelheim Investigational Site
      • Ube, Yamaguchi, Japan
        • 1245.38.023 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 1245.38.026 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 1245.38.027 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 1245.38.028 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 1245.38.029 Boehringer Ingelheim Investigational Site

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Diagnosis of type 2 diabetes mellitus prior to informed consent

  • Male and female patients on diet and exercise regimen who are:

    1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
    2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.

  • HbA1c at Visit 1a:

    1. for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
    2. for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%
  • HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

Exclusion criteria:

  • Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
  • Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
  • Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
  • Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
  • Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
  • Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BI 10773 low dose QD
BI 10773 tablets low dose once a day
Medicin: Placebo (høj dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (mid dose)
Placebo tablets once a day
Medicin: BI 10773
BI 10773 tablets low dose once a day
Medicin: BI 10773
BI 10773 tablets mid-high dose once a day
Medicin: BI 10773
BI 10773 tablets high dose once a day
Medicin: BI 10773
BI 10773 tablets mid-low dose once a day
Eksperimentel: BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
Medicin: Placebo (lav dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (høj dosis)
Placebotabletter én gang dagligt
Medicin: BI 10773
BI 10773 tablets low dose once a day
Medicin: BI 10773
BI 10773 tablets mid-high dose once a day
Medicin: BI 10773
BI 10773 tablets high dose once a day
Medicin: BI 10773
BI 10773 tablets mid-low dose once a day
Eksperimentel: BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
Medicin: Placebo (lav dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (høj dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (mid dose)
Placebo tablets once a day
Medicin: BI 10773
BI 10773 tablets low dose once a day
Medicin: BI 10773
BI 10773 tablets mid-high dose once a day
Medicin: BI 10773
BI 10773 tablets high dose once a day
Medicin: BI 10773
BI 10773 tablets mid-low dose once a day
Eksperimentel: BI 10773 high dose QD
BI 10773 tablets high dose once a day
Medicin: Placebo (lav dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (mid dose)
Placebo tablets once a day
Medicin: BI 10773
BI 10773 tablets low dose once a day
Medicin: BI 10773
BI 10773 tablets mid-high dose once a day
Medicin: BI 10773
BI 10773 tablets high dose once a day
Medicin: BI 10773
BI 10773 tablets mid-low dose once a day
Placebo komparator: Placebo
Placebo tablets once a day
Medicin: Placebo (lav dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (høj dosis)
Placebotabletter én gang dagligt
Medicin: Placebo (mid dose)
Placebo tablets once a day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in HbA1c After 12 Weeks of Treatment.
Tidsramme: baseline and 12 weeks
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of Treat to Target Efficacy Response
Tidsramme: baseline and 12 weeks
Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
baseline and 12 weeks
Change From Baseline in FPG
Tidsramme: baseline and 12 weeks
Change from baseline in FPG after 12 weeks of treatment
baseline and 12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confirmed Hypoglycaemic Adverse Events
Tidsramme: between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Number of patients with confirmed hypoglycaemic adverse events
between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

Samarbejdspartnere

Eli Lilly and Company

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

Hjælpsomme links

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

1. september 2010

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

31. august 2010

Først indsendt, der opfyldte QC-kriterier

31. august 2010

Først opslået (Skøn)

1. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1245.38

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 Diabetes mellitus, type 2

Kliniske forsøg med Placebo (lav dosis)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner