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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

20. januar 2017 opdateret af: Novo Nordisk A/S

A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

467

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Burgas, Bulgarien, 8000
        • Novo Nordisk Investigational Site
      • Ruse, Bulgarien, 7000
        • Novo Nordisk Investigational Site
      • Sofia, Bulgarien, 1606
        • Novo Nordisk Investigational Site
      • Stara Zagora, Bulgarien, 6000
        • Novo Nordisk Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G1N 4V3
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G3K 2P8
        • Novo Nordisk Investigational Site
    • British Columbia
      • Chilliwack, British Columbia, Canada, V2P 4M9
        • Novo Nordisk Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1K 4L2
        • Novo Nordisk Investigational Site
      • Thornhill, Ontario, Canada, L4J 8L7
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35216
        • Novo Nordisk Investigational Site
    • Arizona
      • Peoria, Arizona, Forenede Stater, 85381
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Novo Nordisk Investigational Site
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Novo Nordisk Investigational Site
      • Escondido, California, Forenede Stater, 92025
        • Novo Nordisk Investigational Site
      • La Jolla, California, Forenede Stater, 92037
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Forenede Stater, 90057
        • Novo Nordisk Investigational Site
      • Los Banos, California, Forenede Stater, 93635
        • Novo Nordisk Investigational Site
      • Monterey, California, Forenede Stater, 93940
        • Novo Nordisk Investigational Site
      • Palm Springs, California, Forenede Stater, 92262
        • Novo Nordisk Investigational Site
      • Pasadena, California, Forenede Stater, 91105
        • Novo Nordisk Investigational Site
      • Redondo Beach, California, Forenede Stater, 90277
        • Novo Nordisk Investigational Site
      • San Mateo, California, Forenede Stater, 94401
        • Novo Nordisk Investigational Site
      • Tarzana, California, Forenede Stater, 91356-3551
        • Novo Nordisk Investigational Site
      • Tustin, California, Forenede Stater, 92780
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Novo Nordisk Investigational Site
      • Golden, Colorado, Forenede Stater, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Novo Nordisk Investigational Site
      • DeLand, Florida, Forenede Stater, 32720
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, Forenede Stater, 34741
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forenede Stater, 33156
        • Novo Nordisk Investigational Site
      • Orange Park, Florida, Forenede Stater, 32073
        • Novo Nordisk Investigational Site
      • Plantation, Florida, Forenede Stater, 33324
        • Novo Nordisk Investigational Site
      • Tampa, Florida, Forenede Stater, 33613
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Conyers, Georgia, Forenede Stater, 30094-5965
        • Novo Nordisk Investigational Site
      • Dunwoody, Georgia, Forenede Stater, 30338
        • Novo Nordisk Investigational Site
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60004-2315
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, Forenede Stater, 60607
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, Forenede Stater, 60622
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, Forenede Stater, 62711
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67205
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, Forenede Stater, 41017-3464
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70002
        • Novo Nordisk Investigational Site
    • Maryland
      • Glen Burnie, Maryland, Forenede Stater, 21061
        • Novo Nordisk Investigational Site
      • Reisterstown, Maryland, Forenede Stater, 21136-2516
        • Novo Nordisk Investigational Site
      • Silver Spring, Maryland, Forenede Stater, 20910
        • Novo Nordisk Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106-0482
        • Novo Nordisk Investigational Site
    • Minnesota
      • Eagan, Minnesota, Forenede Stater, 55123
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, Forenede Stater, 11787
        • Novo Nordisk Investigational Site
      • Staten Island, New York, Forenede Stater, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Novo Nordisk Investigational Site
      • Burlington, North Carolina, Forenede Stater, 27215-8700
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, Forenede Stater, 28472
        • Novo Nordisk Investigational Site
      • Winston Salem, North Carolina, Forenede Stater, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45255
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, Forenede Stater, 45406
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Novo Nordisk Investigational Site
      • Altoona, Pennsylvania, Forenede Stater, 16601
        • Novo Nordisk Investigational Site
      • Harrisburg, Pennsylvania, Forenede Stater, 17112-1900
        • Novo Nordisk Investigational Site
      • Langhorne, Pennsylvania, Forenede Stater, 19047
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Novo Nordisk Investigational Site
    • South Carolina
      • Newberry, South Carolina, Forenede Stater, 29108-2249
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, Forenede Stater, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, Forenede Stater, 75251
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forenede Stater, 77025
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, Forenede Stater, 78681
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, Forenede Stater, 84403
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23320
        • Novo Nordisk Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Novo Nordisk Investigational Site
      • Spokane, Washington, Forenede Stater, 99218
        • Novo Nordisk Investigational Site
  • Frankrig
      • LA ROCHE-sur-YON cedex 9, Frankrig, 85295
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, Frankrig, 17019
        • Novo Nordisk Investigational Site
      • Le Creusot, Frankrig, 71200
        • Novo Nordisk Investigational Site
      • Nanterre, Frankrig, 92014
        • Novo Nordisk Investigational Site
      • Narbonne, Frankrig, 11108
        • Novo Nordisk Investigational Site
      • Nimes, Frankrig, 30006
        • Novo Nordisk Investigational Site
      • Paris, Frankrig, 75877
        • Novo Nordisk Investigational Site
      • Venissieux, Frankrig, 69200
        • Novo Nordisk Investigational Site
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Novo Nordisk Investigational Site
      • Beek, Holland, 6191JW
        • Novo Nordisk Investigational Site
      • Etten-Leur, Holland, 4872 LP
        • Novo Nordisk Investigational Site
      • Hengelo, Holland, 7555 DL
        • Novo Nordisk Investigational Site
      • Hoogeveen, Holland, 7909 AA
        • Novo Nordisk Investigational Site
      • Lieshout, Holland, 5737 CB
        • Novo Nordisk Investigational Site
      • Utrecht, Holland, 3582 KE
        • Novo Nordisk Investigational Site
      • Zwijndrecht, Holland, 3331 LZ
        • Novo Nordisk Investigational Site
  • Rumænien
      • Bacau, Rumænien, 600164
        • Novo Nordisk Investigational Site
      • Botosani, Rumænien, 710224
        • Novo Nordisk Investigational Site
      • Bucharest, Rumænien, 010816
        • Novo Nordisk Investigational Site
      • Galati, Rumænien, 800578
        • Novo Nordisk Investigational Site
      • Satu Mare, Rumænien, 440055
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Rumænien, 410469
        • Novo Nordisk Investigational Site
  • Ungarn
      • Budapest, Ungarn, 1125
        • Novo Nordisk Investigational Site
      • Debrecen, Ungarn, 4043
        • Novo Nordisk Investigational Site
      • Eger, Ungarn, 3300
        • Novo Nordisk Investigational Site
      • Gyula, Ungarn, 5700
        • Novo Nordisk Investigational Site
      • Kaposvar, Ungarn, H-7400
        • Novo Nordisk Investigational Site
      • Szeged, Ungarn, H-6720
        • 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 (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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 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 (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
  • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

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
Aktiv komparator: IGlar OD
Medicin: insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
Eksperimentel: IDeg 3TW
Medicin: insulin degludec
Will be injected subcutaneously (under the skin) once daily three times weekly.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i glykosyleret hæmoglobin (HbA1c)
Tidsramme: Uge 0, uge ​​26
Ændring fra baseline i HbA1c efter 26 ugers behandling
Uge 0, uge ​​26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Weight
Tidsramme: Week 0, Week 26
Change from baseline in body weight after 26 weeks of treatment
Week 0, Week 26

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

1. marts 2010

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. december 2010

Datoer for studieregistrering

Først indsendt

25. februar 2010

Først indsendt, der opfyldte QC-kriterier

25. februar 2010

Først opslået (Skøn)

26. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN1250-3718
  • 2009-011399-31 (EudraCT nummer)
  • U1111-1112-8770 (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 .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med insulin degludec

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cambodia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner