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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 maart 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

833

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
      • Porto Alegre, Brazilië, 90035-170
        • Novo Nordisk Investigational Site
      • São Paulo, Brazilië, 04022-002
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazilië, 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
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100029
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100730
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100853
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100700
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100039
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100191
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing, Chongqing, China, 404000
        • Novo Nordisk Investigational Site
      • Chongqing, Chongqing, China, 400010
        • Novo Nordisk Investigational Site
      • Chongqing, Chongqing, China, 400016
        • Novo Nordisk Investigational Site
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Novo Nordisk Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Novo Nordisk Investigational Site
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • Novo Nordisk Investigational Site
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Novo Nordisk Investigational Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Novo Nordisk Investigational Site
      • Shijiazhuang, Hebei, China, 050082
        • Novo Nordisk Investigational Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Novo Nordisk Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430034
        • Novo Nordisk Investigational Site
      • Wuhan, Hubei, China, 430030
        • Novo Nordisk Investigational Site
    • Hunan
      • Yueyang, Hunan, China, 414000
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Novo Nordisk Investigational Site
      • Zhenjiang, Jiangsu, China, 212001
        • Novo Nordisk Investigational Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Novo Nordisk Investigational Site
    • Jilin
      • Changchun, Jilin, China, 130041
        • Novo Nordisk Investigational Site
      • Siping, Jilin, China, 136000
        • Novo Nordisk Investigational Site
    • Liaoning
      • Shenyang, Liaoning, China, 110021
        • Novo Nordisk Investigational Site
      • Shenyang, Liaoning, China, 110004
        • Novo Nordisk Investigational Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200072
        • Novo Nordisk Investigational Site
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • Novo Nordisk Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Novo Nordisk Investigational Site
      • Wenzhou, Zhejiang, China, 325000
        • Novo Nordisk Investigational Site
  • Oekraïne
      • Dnepropetrovsk, Oekraïne, 49005
        • Novo Nordisk Investigational Site
      • Dnepropetrovsk, Oekraïne, 49038
        • Novo Nordisk Investigational Site
      • Kiev, Oekraïne, 04114
        • Novo Nordisk Investigational Site
      • Mykolaiv, Oekraïne, 54003
        • Novo Nordisk Investigational Site
      • Vinnitsa, Oekraïne, 21010
        • Novo Nordisk Investigational Site
  • Roemenië
      • Bucharest, Roemenië, 020614
        • Novo Nordisk Investigational Site
      • Buzau, Roemenië, 120203
        • Novo Nordisk Investigational Site
      • Galati, Roemenië, 800578
        • Novo Nordisk Investigational Site
      • Sibiu, Roemenië, 550176
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Roemenië, 410469
        • Novo Nordisk Investigational Site
  • Verenigde Staten
    • California
      • Anaheim, California, Verenigde Staten, 92801
        • Novo Nordisk Investigational Site
      • Lomita, California, Verenigde Staten, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Verenigde Staten, 90057
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden, Colorado, Verenigde Staten, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, Verenigde Staten, 33765
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60607
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, Verenigde Staten, 41017-3464
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, Verenigde Staten, 70002
        • Novo Nordisk Investigational Site
    • Michigan
      • Troy, Michigan, Verenigde Staten, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, Verenigde Staten, 63017
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, Verenigde Staten, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Toms River, New Jersey, Verenigde Staten, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, Verenigde Staten, 11787
        • Novo Nordisk Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, Verenigde Staten, 29681
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson, Tennessee, Verenigde Staten, 38305
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, Verenigde Staten, 75230
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, Verenigde Staten, 23606
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, Verenigde Staten, 53142
        • Novo Nordisk Investigational Site
  • Zuid-Afrika
    • Eastern Cape
      • George, Eastern Cape, Zuid-Afrika, 6529
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, Zuid-Afrika, 2193
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, Zuid-Afrika, 1812
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Zuid-Afrika, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, Zuid-Afrika, 4091
        • Novo Nordisk Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Insulin Degludec
Geneesmiddel: 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.
Andere namen:
  • NN1250
Experimenteel: Insulin Glargine
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Tijdsspanne: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novo Nordisk A/S

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juni 2013

Primaire voltooiing (Werkelijk)

15 mei 2014

Studie voltooiing (Werkelijk)

15 mei 2014

Studieregistratiedata

Eerst ingediend

6 mei 2013

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2013

Eerst geplaatst (Schatting)

8 mei 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 april 2017

Laatste update ingediend die voldeed aan QC-criteria

9 maart 2017

Laatst geverifieerd

1 maart 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NN1250-3587
  • U1111-1121-5325 (Andere identificatie: WHO)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus, type 2

Klinische onderzoeken op Insulin Degludec

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Voorwaarden

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Locaties

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