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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 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

833

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Insulin Degludec
Médicament: 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.
Autres noms:
  • NN1250
Expérimental: Insulin Glargine
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Délai: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novo Nordisk A/S

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2013

Achèvement primaire (Réel)

15 mai 2014

Achèvement de l'étude (Réel)

15 mai 2014

Dates d'inscription aux études

Première soumission

6 mai 2013

Première soumission répondant aux critères de contrôle qualité

6 mai 2013

Première publication (Estimation)

8 mai 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 mars 2017

Dernière vérification

1 mars 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NN1250-3587
  • U1111-1121-5325 (Autre identifiant: WHO)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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