Health Condition 1: E10- Type 1 diabetes mellitus
Conditions
Interventions
Intervention1: NN1250: Injected subcutaneously (under the skin) once daily.The dose will be individually adjusted.
Control Intervention1: insulin detemir (Levemir®
): Injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
Control Intervention2: insulin aspart: Injected subcutaneously (under the skin) as mealtime insulin.The
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: Completed the six-month treatment period in trial NN1250-3585
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hypoglycaemic episodesTimepoint: After 26 weeks of treatment;Number of medical event of special interest (MESI)Timepoint: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose (FPG)Timepoint: After 26 weeks of Treatment;Change from baseline in HbA1c (glycosylated haemoglobin A1c)Timepoint: After 26 weeks of Treatment;Plasma glucose profilesTimepoint: After 26 weeks of Treatment | — |
Countries
Brazil, Finland, India, Italy, Japan, United Kingdom
Contacts
Public ContactMr Avik Kumar Ghosh
Novo Nordisk India Private Limited. Novo Nordisk India Private Limited.
Outcome results
None listed