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Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

16. mai 2014 oppdatert av: Boehringer Ingelheim

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

986

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Bruxelles, Belgia
        • 1245.20.32008 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgia
        • 1245.20.32011 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgia
        • 1245.20.32023 Boehringer Ingelheim Investigational Site
      • De Pinte, Belgia
        • 1245.20.32003 Boehringer Ingelheim Investigational Site
      • Deurne, Belgia
        • 1245.20.32015 Boehringer Ingelheim Investigational Site
      • Deurne, Belgia
        • 1245.20.32016 Boehringer Ingelheim Investigational Site
      • Gozée, Belgia
        • 1245.20.32025 Boehringer Ingelheim Investigational Site
      • Landen, Belgia
        • 1245.20.32022 Boehringer Ingelheim Investigational Site
      • Leopoldsburg, Belgia
        • 1245.20.32019 Boehringer Ingelheim Investigational Site
      • Linkebeek, Belgia
        • 1245.20.32024 Boehringer Ingelheim Investigational Site
      • Mouscron, Belgia
        • 1245.20.32021 Boehringer Ingelheim Investigational Site
      • Retie, Belgia
        • 1245.20.32027 Boehringer Ingelheim Investigational Site
      • Sint-Gillis-Waas, Belgia
        • 1245.20.32020 Boehringer Ingelheim Investigational Site
      • Tielt, Belgia
        • 1245.20.32018 Boehringer Ingelheim Investigational Site
      • Tremelo, Belgia
        • 1245.20.32026 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Chilliwack, British Columbia, Canada
        • 1245.20.20011 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 1245.20.20018 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1245.20.20015 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • 1245.20.20012 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
        • 1245.20.20016 Boehringer Ingelheim Investigational Site
      • St. John's, Newfoundland and Labrador, Canada
        • 1245.20.20008 Boehringer Ingelheim Investigational Site
    • Ontario
      • Barrie, Ontario, Canada
        • 1245.20.20001 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1245.20.20019 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1245.20.20010 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1245.20.20017 Boehringer Ingelheim Investigational Site
      • Markham, Ontario, Canada
        • 1245.20.20003 Boehringer Ingelheim Investigational Site
      • Newmarket, Ontario, Canada
        • 1245.20.20009 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1245.20.20013 Boehringer Ingelheim Investigational Site
      • Strathroy, Ontario, Canada
        • 1245.20.20005 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1245.20.20002 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1245.20.20006 Boehringer Ingelheim Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • 1245.20.20014 Boehringer Ingelheim Investigational Site
      • Montague, Prince Edward Island, Canada
        • 1245.20.20007 Boehringer Ingelheim Investigational Site
    • Quebec
      • Trois Rivieres, Quebec, Canada
        • 1245.20.20021 Boehringer Ingelheim Investigational Site
  • Forente stater
    • Arizona
      • Mesa, Arizona, Forente stater
        • 1245.20.10124 Boehringer Ingelheim Investigational Site
      • Phoenix, Arizona, Forente stater
        • 1245.20.10108 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, Forente stater
        • 1245.20.10150 Boehringer Ingelheim Investigational Site
    • California
      • Chino, California, Forente stater
        • 1245.20.10154 Boehringer Ingelheim Investigational Site
      • Santa Ana, California, Forente stater
        • 1245.20.10009 Boehringer Ingelheim Investigational Site
      • West Hills, California, Forente stater
        • 1245.20.10131 Boehringer Ingelheim Investigational Site
    • Colorado
      • Northglenn, Colorado, Forente stater
        • 1245.20.10038 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, Forente stater
        • 1245.20.10137 Boehringer Ingelheim Investigational Site
      • Miami, Florida, Forente stater
        • 1245.20.10006 Boehringer Ingelheim Investigational Site
      • Plantation, Florida, Forente stater
        • 1245.20.10085 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Forente stater
        • 1245.20.10078 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, Forente stater
        • 1245.20.10080 Boehringer Ingelheim Investigational Site
    • Indiana
      • Avon, Indiana, Forente stater
        • 1245.20.10128 Boehringer Ingelheim Investigational Site
      • Fishers, Indiana, Forente stater
        • 1245.20.10060 Boehringer Ingelheim Investigational Site
      • Indianapolis, Indiana, Forente stater
        • 1245.20.10065 Boehringer Ingelheim Investigational Site
    • Kansas
      • Arkansas City, Kansas, Forente stater
        • 1245.20.10117 Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, Forente stater
        • 1245.20.10039 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forente stater
        • 1245.20.10146 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, Forente stater
        • 1245.20.10144 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Brick, New Jersey, Forente stater
        • 1245.20.10115 Boehringer Ingelheim Investigational Site
    • Ohio
      • Carlisle, Ohio, Forente stater
        • 1245.20.10129 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, Forente stater
        • 1245.20.10045 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, Forente stater
        • 1245.20.10119 Boehringer Ingelheim Investigational Site
      • Gallipolis, Ohio, Forente stater
        • 1245.20.10130 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, Forente stater
        • 1245.20.10089 Boehringer Ingelheim Investigational Site
      • Hurst, Texas, Forente stater
        • 1245.20.10151 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, Forente stater
        • 1245.20.10155 Boehringer Ingelheim Investigational Site
  • India
      • Bangalore, India
        • 1245.20.91005 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1245.20.91006 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1245.20.91008 Boehringer Ingelheim Investigational Site
      • Belgaum, India
        • 1245.20.91003 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1245.20.91004 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1245.20.91009 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1245.20.91002 Boehringer Ingelheim Investigational Site
      • Mumbai, Maharastra, India
        • 1245.20.91007 Boehringer Ingelheim Investigational Site
      • Nagpur, India
        • 1245.20.91010 Boehringer Ingelheim Investigational Site
      • Tamil Nadu, India
        • 1245.20.91001 Boehringer Ingelheim Investigational Site
  • Irland
      • Co. Cork, Irland
        • 1245.20.35302 Boehringer Ingelheim Investigational Site
      • Co. Galway, Irland
        • 1245.20.35305 Boehringer Ingelheim Investigational Site
      • Co. Wexford, Irland
        • 1245.20.35303 Boehringer Ingelheim Investigational Site
      • Offaly, Irland
        • 1245.20.35304 Boehringer Ingelheim Investigational Site
      • Wexford, Irland
        • 1245.20.35306 Boehringer Ingelheim Investigational Site
  • Japan
      • Chiyoda-ku, Tokyo, Japan
        • 1245.20.81007 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.20.81001 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.20.81002 Boehringer Ingelheim Investigational Site
      • Ebetsu, Hokkaido, Japan
        • 1245.20.81005 Boehringer Ingelheim Investigational Site
      • Kamakura, Kanagawa, Japan
        • 1245.20.81004 Boehringer Ingelheim Investigational Site
      • Minato-ku, Tokyo, Japan
        • 1245.20.81003 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1245.20.81006 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1245.20.81008 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1245.20.81009 Boehringer Ingelheim Investigational Site
      • Ube, Yamaguchi, Japan
        • 1245.20.81010 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 1245.20.81012 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 1245.20.81013 Boehringer Ingelheim Investigational Site
  • Kina
      • Beijing, Kina
        • 1245.20.86007 Boehringer Ingelheim Investigational Site
      • Beijing, Kina
        • 1245.20.86008 Boehringer Ingelheim Investigational Site
      • Guangzhou, Kina
        • 1245.20.86001 Boehringer Ingelheim Investigational Site
      • Guangzhou, Kina
        • 1245.20.86002 Boehringer Ingelheim Investigational Site
      • Guangzhou, Kina
        • 1245.20.86003 Boehringer Ingelheim Investigational Site
      • Guiyang, Kina
        • 1245.20.86012 Boehringer Ingelheim Investigational Site
      • Hangzhou, Kina
        • 1245.20.86020 Boehringer Ingelheim Investigational Site
      • Jinan, Kina
        • 1245.20.86049 Boehringer Ingelheim Investigational Site
      • Jingzhou, Kina
        • 1245.20.86018 Boehringer Ingelheim Investigational Site
      • Nanchang, Kina
        • 1245.20.86019 Boehringer Ingelheim Investigational Site
      • Nanjing, Kina
        • 1245.20.86010 Boehringer Ingelheim Investigational Site
      • Nanjing, Kina
        • 1245.20.86043 Boehringer Ingelheim Investigational Site
      • QingDao, Kina
        • 1245.20.86016 Boehringer Ingelheim Investigational Site
      • Shanghai, Kina
        • 1245.20.86004 Boehringer Ingelheim Investigational Site
      • Shanghai, Kina
        • 1245.20.86005 Boehringer Ingelheim Investigational Site
      • Shanghai, Kina
        • 1245.20.86006 Boehringer Ingelheim Investigational Site
      • Shenyang, Kina
        • 1245.20.86057 Boehringer Ingelheim Investigational Site
      • Shiyan, Kina
        • 1245.20.86017 Boehringer Ingelheim Investigational Site
      • Suzhou, Kina
        • 1245.20.86013 Boehringer Ingelheim Investigational Site
      • Taiyuan, Kina
        • 1245.20.86015 Boehringer Ingelheim Investigational Site
      • Wuhan, Kina
        • 1245.20.86009 Boehringer Ingelheim Investigational Site
      • Xi'An, Kina
        • 1245.20.86011 Boehringer Ingelheim Investigational Site
      • Xiamen, Kina
        • 1245.20.86014 Boehringer Ingelheim Investigational Site
  • Sveits
      • Lugano, Sveits
        • 1245.20.41004 Boehringer Ingelheim Investigational Site
      • Rorschach, Sveits
        • 1245.20.41003 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Dresden, Tyskland
        • 1245.20.49013 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Tyskland
        • 1245.20.49016 Boehringer Ingelheim Investigational Site
      • Frankfurt, Tyskland
        • 1245.20.49015 Boehringer Ingelheim Investigational Site
      • Haag, Tyskland
        • 1245.20.49019 Boehringer Ingelheim Investigational Site
      • Hohenmölsen, Tyskland
        • 1245.20.49020 Boehringer Ingelheim Investigational Site
      • Köthen, Tyskland
        • 1245.20.49014 Boehringer Ingelheim Investigational Site
      • Neuwied, Tyskland
        • 1245.20.49002 Boehringer Ingelheim Investigational Site
      • Nürnberg, Tyskland
        • 1245.20.49008 Boehringer Ingelheim Investigational Site
      • Schauenburg, Tyskland
        • 1245.20.49022 Boehringer Ingelheim Investigational Site
      • St. Ingbert/Oberwürzbach, Tyskland
        • 1245.20.49017 Boehringer Ingelheim Investigational Site
      • Unterschneidheim, Tyskland
        • 1245.20.49003 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent;
  2. Male and female patients on diet and exercise regimen who are drug-naïve;
  3. HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
  4. Age >= 20 (Japan); Age >= 18 (countries other than Japan);
  5. BMI <= 45 kg/m2 at Visit 1 (screening);
  6. Signed and dated written informed consent by date of Visit 1

Exclusion criteria:

  1. Uncontrolled hyperglycaemia;
  2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
  3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
  4. Impaired renal function (eGFR<50 ml/min);
  5. Bariatric surgery within the past two years or other GI surgeries;
  6. Medical history of cancer;
  7. Contraindications to sitagliptin;
  8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
  9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
  10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
  11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
  12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
  13. Alcohol or drug abuse;
  14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
  15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: BI 10773 low dose
Patients receive BI 10773 low dose tablets once daily
Legemiddel: BI 10773
BI 10773 lavdosetablett én gang daglig
Legemiddel: Placebo identical to BI10773 high dose
placebo tablets once daily
Legemiddel: Placebo identical to Sitagliptin 100mg
placebo tablets once daily
Eksperimentell: BI 10773 high dose
Patients receive BI 10773 high dose tablets once daily
Legemiddel: Placebo identical to Sitagliptin 100mg
placebo tablets once daily
Legemiddel: Placebo identical to BI10773 low dose
placebo tablets once daily
Legemiddel: BI10773
BI 10773 high dose tablets once daily
Placebo komparator: Placebo
Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Legemiddel: Placebo identical to BI10773 high dose
placebo tablets once daily
Legemiddel: Placebo identical to Sitagliptin 100mg
placebo tablets once daily
Legemiddel: Placebo identical to BI10773 low dose
placebo tablets once daily
Aktiv komparator: Sitagliptin 100 mg
Patients receive Sitagliptin 100 mg tablets once daily
Legemiddel: Placebo identical to BI10773 high dose
placebo tablets once daily
Legemiddel: Placebo identical to BI10773 low dose
placebo tablets once daily
Legemiddel: Sitagliptin
Sitagliptin tablets 100 mg once daily
Eksperimentell: BI 10773 high dose open label
Patients receive BI 10773 high dose tablets open label once daily
Legemiddel: BI 10773 open label
Patients receive BI 10773 high dose tablets open label once daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
Tidsramme: Baseline and day 169

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Baseline and day 169

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline to Week 24 in Body Weight
Tidsramme: Baseline and day 169

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Baseline and day 169
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
Tidsramme: Baseline and week 24

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.
Baseline and week 24

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Confirmed Hypoglycaemic Adverse Events
Tidsramme: From first drug intake until 7 days after last medication intake, up to 219 days

Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.

Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category.
From first drug intake until 7 days after last medication intake, up to 219 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Samarbeidspartnere

Eli Lilly and Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2010

Primær fullføring (Faktiske)

1. mars 2012

Datoer for studieregistrering

Først innsendt

29. juli 2010

Først innsendt som oppfylte QC-kriteriene

6. august 2010

Først lagt ut (Anslag)

9. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2014

Sist bekreftet

1. mai 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1245.20
  • 2009-016243-20 (EudraCT-nummer: EudraCT)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere