Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For MAIN period (NN5401-3590):
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
Body Mass Index (BMI) no higher than 40.0 kg/m\^2
For EXTENSION period (NN5401-3726):
Informed consent obtained before any trial-related activities
Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590
You may not be if
For MAIN period (NN5401-3590):
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
For EXTENSION period (NN5401-3726):
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
