A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

CompletadoFase 3ClinicalTrials.gov

ID: NCT02501161Tipo: INTERVENTIONALInicio: 31 de ene de 2016Fin estimado: 3 de oct de 2018

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Resumen

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Subjects diagnosed with type 2 diabetes mellitus
HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
Body mass index greater than or equal to 20 kg/m\^2
Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Criterios de exclusión

Screening calcitonin greater than or equal to 50 ng/L
Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
History of pancreatitis (acute or chronic)

Intervenciones

drug

insulin degludec/liraglutide

Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.

drug

insulin glargine

Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

CABA, Argentina

Novo Nordisk Investigational Site

Capital Federal, Argentina

Novo Nordisk Investigational Site

Mendoza, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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