Ensayo clínico que compara la eficacia y seguridad de insulin degludec/liraglutide (IDegLira) versus terapia basal-bolo en sujetos con diabetes mellitus tipo 2

Criterios de inclusión

• Male or female, age at least 18 years at the time of signing informed consent
• Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
• HbA1c (glycosylated haemoglobin) 7.0-10.0% \[53mmol/mol-86mmol/mol\] (both inclusive) by central laboratory analysis
• Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
• Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
• Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
• Body mass index (BMI) below or equal to 40 kg/m\^2
• Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
• Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
• Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
• Screening calcitonin at least 50 ng/L
• History of pancreatitis (acute or chronic)
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2