A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Novo Nordisk A/S
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
HbA1c 7.0% - 10.0%
Body mass index (BMI) less than or equal to 40.0 kg/m\^2
Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Chronic disorder or disease which might jeopardise safety or compliance
Malignant neoplasms
Recurrent severe hypoglycaemia
Clareo Health | A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin