A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™)
9 de marzo de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
833
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Porto Alegre, Brasil, 90035-170
- Novo Nordisk Investigational Site
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São Paulo, Brasil, 04022-002
- Novo Nordisk Investigational Site
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Sao Paulo
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São Paulo, Sao Paulo, Brasil, 01244-030
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Quebec, Canadá, G3K 2P8
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Alberta
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Calgary, Alberta, Canadá, T2N 4L7
- Novo Nordisk Investigational Site
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British Columbia
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Burnaby, British Columbia, Canadá, V5G 1T4
- Novo Nordisk Investigational Site
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Surrey, British Columbia, Canadá, V3S 2N6
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Victoria, British Columbia, Canadá, V8V 4A1
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Ontario
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Burlington, Ontario, Canadá, L7M 4Y1
- Novo Nordisk Investigational Site
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London, Ontario, Canadá, N5W 6A2
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London, Ontario, Canadá, N6P 1A9
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Newmarket, Ontario, Canadá, L3Y 5G8
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Sarnia, Ontario, Canadá, N7T 4X3
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Strathroy, Ontario, Canadá, N7G 1Y7
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Quebec
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Trois Rivieres, Quebec, Canadá, G8T7A1
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California
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Anaheim, California, Estados Unidos, 92801
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Lomita, California, Estados Unidos, 90717
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Los Angeles, California, Estados Unidos, 90057
- Novo Nordisk Investigational Site
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Colorado
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Golden, Colorado, Estados Unidos, 80401
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Florida
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Clearwater, Florida, Estados Unidos, 33765
- Novo Nordisk Investigational Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60607
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Kentucky
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Crestview Hills, Kentucky, Estados Unidos, 41017-3464
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70002
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Michigan
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Troy, Michigan, Estados Unidos, 48098
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Missouri
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Chesterfield, Missouri, Estados Unidos, 63017
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New Hampshire
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Nashua, New Hampshire, Estados Unidos, 03063
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New Jersey
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Toms River, New Jersey, Estados Unidos, 08755-8050
- Novo Nordisk Investigational Site
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New York
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Smithtown, New York, Estados Unidos, 11787
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South Carolina
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Simpsonville, South Carolina, Estados Unidos, 29681
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38305
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Texas
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Dallas, Texas, Estados Unidos, 75230
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Virginia
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Newport News, Virginia, Estados Unidos, 23606
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Wisconsin
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Kenosha, Wisconsin, Estados Unidos, 53142
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Anhui
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Hefei, Anhui, Porcelana, 230001
- Novo Nordisk Investigational Site
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Beijing
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Beijing, Beijing, Porcelana, 100029
- Novo Nordisk Investigational Site
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Beijing, Beijing, Porcelana, 100730
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Beijing, Beijing, Porcelana, 100853
- Novo Nordisk Investigational Site
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Beijing, Beijing, Porcelana, 100700
- Novo Nordisk Investigational Site
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Beijing, Beijing, Porcelana, 100039
- Novo Nordisk Investigational Site
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Beijing, Beijing, Porcelana, 100191
- Novo Nordisk Investigational Site
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Chongqing
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ChongQing, Chongqing, Porcelana, 404000
- Novo Nordisk Investigational Site
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Chongqing, Chongqing, Porcelana, 400010
- Novo Nordisk Investigational Site
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Chongqing, Chongqing, Porcelana, 400016
- Novo Nordisk Investigational Site
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Fujian
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Fuzhou, Fujian, Porcelana, 350025
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510120
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Guangxi
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Nanning, Guangxi, Porcelana, 530007
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Guizhou
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Guiyang, Guizhou, Porcelana, 550004
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Hebei
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Shijiazhuang, Hebei, Porcelana, 050051
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Shijiazhuang, Hebei, Porcelana, 050082
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150086
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Hubei
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Wuhan, Hubei, Porcelana, 430034
- Novo Nordisk Investigational Site
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Wuhan, Hubei, Porcelana, 430030
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Hunan
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Yueyang, Hunan, Porcelana, 414000
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Jiangsu
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Yangzhou, Jiangsu, Porcelana, 225001
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Zhenjiang, Jiangsu, Porcelana, 212001
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
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Jilin
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Changchun, Jilin, Porcelana, 130041
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Siping, Jilin, Porcelana, 136000
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Liaoning
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Shenyang, Liaoning, Porcelana, 110021
- Novo Nordisk Investigational Site
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Shenyang, Liaoning, Porcelana, 110004
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710032
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Shanghai
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Shanghai, Shanghai, Porcelana, 200040
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Shanghai, Shanghai, Porcelana, 200072
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Yunnan
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Kunming, Yunnan, Porcelana, 650101
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310003
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Wenzhou, Zhejiang, Porcelana, 325000
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Bucharest, Rumania, 020614
- Novo Nordisk Investigational Site
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Buzau, Rumania, 120203
- Novo Nordisk Investigational Site
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Galati, Rumania, 800578
- Novo Nordisk Investigational Site
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Sibiu, Rumania, 550176
- Novo Nordisk Investigational Site
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Bihor
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Oradea, Bihor, Rumania, 410469
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Eastern Cape
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George, Eastern Cape, Sudáfrica, 6529
- Novo Nordisk Investigational Site
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Gauteng
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Johannesburg, Gauteng, Sudáfrica, 2193
- Novo Nordisk Investigational Site
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Johannesburg, Gauteng, Sudáfrica, 1812
- Novo Nordisk Investigational Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sudáfrica, 4001
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Durban, KwaZulu-Natal, Sudáfrica, 4091
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Dnepropetrovsk, Ucrania, 49005
- Novo Nordisk Investigational Site
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Dnepropetrovsk, Ucrania, 49038
- Novo Nordisk Investigational Site
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Kiev, Ucrania, 04114
- Novo Nordisk Investigational Site
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Mykolaiv, Ucrania, 54003
- Novo Nordisk Investigational Site
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Vinnitsa, Ucrania, 21010
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Insulin Degludec
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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.
Otros nombres:
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Experimental: Insulin Glargine
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Periodo de tiempo: Week 0, week 26
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Change from baseline in HbA1c (%) after 26 weeks of treatment.
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Week 0, week 26
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Periodo de tiempo: 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)
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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).
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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)
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Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
Periodo de tiempo: Week 0, week 26
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Change from baseline in FPG after 26 weeks of treatment.
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Week 0, week 26
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Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
Periodo de tiempo: Week 26
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Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.
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Week 26
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Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
Periodo de tiempo: Week 26
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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.
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Week 26
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Number of Treatment Emergent AEs (Adverse Events)
Periodo de tiempo: 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)
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Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
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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)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pan C, Gross JL, Yang W, Lv X, Sun L, Hansen CT, Xu H, Wagner R. A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naive Patients with Type 2 Diabetes Mellitus. Drugs R D. 2016 Jun;16(2):239-49. doi: 10.1007/s40268-016-0134-z.
- Mu YM, Guo LX, Li L, Li YM, Xu XJ, Li QM, Xu MT, Zhu LY, Yuan GY, Liu Y, Xu C, Wang ZJ, Shen FX, Luo Y, Liu JY, Li QF, Wang WH, Lai XY, Xu HF, Pan CY. [The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial]. Zhonghua Nei Ke Za Zhi. 2017 Sep 1;56(9):660-666. doi: 10.3760/cma.j.issn.0578-1426.2017.09.008. Chinese.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de junio de 2013
Finalización primaria (Actual)
15 de mayo de 2014
Finalización del estudio (Actual)
15 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2013
Publicado por primera vez (Estimar)
8 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NN1250-3587
- U1111-1121-5325 (Otro identificador: WHO)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .