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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. marts 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

833

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Brasilien
      • Porto Alegre, Brasilien, 90035-170
        • Novo Nordisk Investigational Site
      • São Paulo, Brasilien, 04022-002
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo, Sao Paulo, Brasilien, 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
  • Forenede Stater
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Novo Nordisk Investigational Site
      • Lomita, California, Forenede Stater, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Forenede Stater, 90057
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden, Colorado, Forenede Stater, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33765
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, Forenede Stater, 41017-3464
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70002
        • Novo Nordisk Investigational Site
    • Michigan
      • Troy, Michigan, Forenede Stater, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Toms River, New Jersey, Forenede Stater, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, Forenede Stater, 11787
        • Novo Nordisk Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, Forenede Stater, 29681
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, Forenede 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
  • Rumænien
      • Bucharest, Rumænien, 020614
        • Novo Nordisk Investigational Site
      • Buzau, Rumænien, 120203
        • Novo Nordisk Investigational Site
      • Galati, Rumænien, 800578
        • Novo Nordisk Investigational Site
      • Sibiu, Rumænien, 550176
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Rumænien, 410469
        • Novo Nordisk Investigational Site
  • Sydafrika
    • Eastern Cape
      • George, Eastern Cape, Sydafrika, 6529
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2193
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, Sydafrika, 1812
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sydafrika, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, Sydafrika, 4091
        • Novo Nordisk Investigational Site
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49005
        • Novo Nordisk Investigational Site
      • Dnepropetrovsk, Ukraine, 49038
        • Novo Nordisk Investigational Site
      • Kiev, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Mykolaiv, Ukraine, 54003
        • Novo Nordisk Investigational Site
      • Vinnitsa, Ukraine, 21010
        • Novo Nordisk 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Insulin Degludec
Medicin: 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 navne:
  • NN1250
Eksperimentel: Insulin Glargine
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

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

Sponsor

Novo Nordisk A/S

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 (Faktiske)

2. juni 2013

Primær færdiggørelse (Faktiske)

15. maj 2014

Studieafslutning (Faktiske)

15. maj 2014

Datoer for studieregistrering

Først indsendt

6. maj 2013

Først indsendt, der opfyldte QC-kriterier

6. maj 2013

Først opslået (Skøn)

8. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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 .

Abonner