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A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™)

9. mars 2017 oppdatert av: Novo Nordisk A/S

A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

833

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Brasil
      • Porto Alegre, Brasil, 90035-170
        • Novo Nordisk Investigational Site
      • São Paulo, Brasil, 04022-002
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo, Sao Paulo, Brasil, 01244-030
        • Novo Nordisk Investigational Site
  • Canada
      • Quebec, Canada, G3K 2P8
        • Novo Nordisk Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
        • Novo Nordisk Investigational Site
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
        • Novo Nordisk Investigational Site
      • Surrey, British Columbia, Canada, V3S 2N6
        • Novo Nordisk Investigational Site
      • Victoria, British Columbia, Canada, V8V 4A1
        • Novo Nordisk Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N5W 6A2
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6P 1A9
        • Novo Nordisk Investigational Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Novo Nordisk Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Novo Nordisk Investigational Site
      • Strathroy, Ontario, Canada, N7G 1Y7
        • Novo Nordisk Investigational Site
    • Quebec
      • Trois Rivieres, Quebec, Canada, G8T7A1
        • Novo Nordisk Investigational Site
  • Forente stater
    • California
      • Anaheim, California, Forente stater, 92801
        • Novo Nordisk Investigational Site
      • Lomita, California, Forente stater, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Forente stater, 90057
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden, Colorado, Forente stater, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, Forente stater, 33765
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60607
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, Forente stater, 41017-3464
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70002
        • Novo Nordisk Investigational Site
    • Michigan
      • Troy, Michigan, Forente stater, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63017
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, Forente stater, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Toms River, New Jersey, Forente stater, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, Forente stater, 11787
        • Novo Nordisk Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, Forente stater, 29681
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson, Tennessee, Forente stater, 38305
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, Forente stater, 23606
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, Forente stater, 53142
        • Novo Nordisk Investigational Site
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230001
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, Kina, 100029
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, Kina, 100730
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, Kina, 100853
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, Kina, 100700
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, Kina, 100039
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, Kina, 100191
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing, Chongqing, Kina, 404000
        • Novo Nordisk Investigational Site
      • Chongqing, Chongqing, Kina, 400010
        • Novo Nordisk Investigational Site
      • Chongqing, Chongqing, Kina, 400016
        • Novo Nordisk Investigational Site
    • Fujian
      • Fuzhou, Fujian, Kina, 350025
        • Novo Nordisk Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510120
        • Novo Nordisk Investigational Site
    • Guangxi
      • Nanning, Guangxi, Kina, 530007
        • Novo Nordisk Investigational Site
    • Guizhou
      • Guiyang, Guizhou, Kina, 550004
        • Novo Nordisk Investigational Site
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050051
        • Novo Nordisk Investigational Site
      • Shijiazhuang, Hebei, Kina, 050082
        • Novo Nordisk Investigational Site
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150086
        • Novo Nordisk Investigational Site
    • Hubei
      • Wuhan, Hubei, Kina, 430034
        • Novo Nordisk Investigational Site
      • Wuhan, Hubei, Kina, 430030
        • Novo Nordisk Investigational Site
    • Hunan
      • Yueyang, Hunan, Kina, 414000
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Yangzhou, Jiangsu, Kina, 225001
        • Novo Nordisk Investigational Site
      • Zhenjiang, Jiangsu, Kina, 212001
        • Novo Nordisk Investigational Site
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Novo Nordisk Investigational Site
    • Jilin
      • Changchun, Jilin, Kina, 130041
        • Novo Nordisk Investigational Site
      • Siping, Jilin, Kina, 136000
        • Novo Nordisk Investigational Site
    • Liaoning
      • Shenyang, Liaoning, Kina, 110021
        • Novo Nordisk Investigational Site
      • Shenyang, Liaoning, Kina, 110004
        • Novo Nordisk Investigational Site
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, Kina, 200040
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, Kina, 200072
        • Novo Nordisk Investigational Site
    • Yunnan
      • Kunming, Yunnan, Kina, 650101
        • Novo Nordisk Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Novo Nordisk Investigational Site
      • Wenzhou, Zhejiang, Kina, 325000
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 020614
        • Novo Nordisk Investigational Site
      • Buzau, Romania, 120203
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800578
        • Novo Nordisk Investigational Site
      • Sibiu, Romania, 550176
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
  • Sør-Afrika
    • Eastern Cape
      • George, Eastern Cape, Sør-Afrika, 6529
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, Sør-Afrika, 2193
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, Sør-Afrika, 1812
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sør-Afrika, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, Sør-Afrika, 4091
        • Novo Nordisk Investigational Site
  • Ukraina
      • Dnepropetrovsk, Ukraina, 49005
        • Novo Nordisk Investigational Site
      • Dnepropetrovsk, Ukraina, 49038
        • Novo Nordisk Investigational Site
      • Kiev, Ukraina, 04114
        • Novo Nordisk Investigational Site
      • Mykolaiv, Ukraina, 54003
        • Novo Nordisk Investigational Site
      • Vinnitsa, Ukraina, 21010
        • Novo Nordisk 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:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
  • Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
  • Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial product(s) or related products

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Insulin Degludec
Legemiddel: Insulin Degludec
Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
Andre navn:
  • NN1250
Eksperimentell: Insulin Glargine
Legemiddel: Insulin Glargine
Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Tidsramme: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Tidsramme: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).
On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
Tidsramme: Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment.
Week 0, week 26
Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
Tidsramme: Week 26
Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.
Week 26
Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
Tidsramme: Week 26
A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.
Week 26
Number of Treatment Emergent AEs (Adverse Events)
Tidsramme: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)

Samarbeidspartnere og etterforskere

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

Sponsor

Novo Nordisk A/S

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 (Faktiske)

2. juni 2013

Primær fullføring (Faktiske)

15. mai 2014

Studiet fullført (Faktiske)

15. mai 2014

Datoer for studieregistrering

Først innsendt

6. mai 2013

Først innsendt som oppfylte QC-kriteriene

6. mai 2013

Først lagt ut (Anslag)

8. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NN1250-3587
  • U1111-1121-5325 (Annen identifikator: WHO)

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