A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01046110Tipo: INTERVENTIONALInicio: 1 de ene de 2010Fin estimado: 1 de nov de 2010

Traducción no disponible, mostrando original

Resumen

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes (diagnosed clinically) for at least 6 months
Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination 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 or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Criterios de exclusión

Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
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)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)

Intervenciones

drug

insulin degludec

Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.

drug

sitagliptin

Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Caba, Argentina

Novo Nordisk Investigational Site

Ciudad Autónoma de BsAs, Argentina

Novo Nordisk Investigational Site

Córdoba, Argentina

Novo Nordisk Investigational Site

Mar del Plata, Argentina

Novo Nordisk Investigational Site

Mendoza, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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