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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 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

833

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Insulin Degludec
Droga: 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.
Altri nomi:
  • NN1250
Sperimentale: Insulin Glargine
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Lasso di tempo: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novo Nordisk A/S

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 giugno 2013

Completamento primario (Effettivo)

15 maggio 2014

Completamento dello studio (Effettivo)

15 maggio 2014

Date di iscrizione allo studio

Primo inviato

6 maggio 2013

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2013

Primo Inserito (Stima)

8 maggio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NN1250-3587
  • U1111-1121-5325 (Altro identificatore: WHO)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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