Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: NN5401: Injected sub cutaneous under the skin once daily with the breakfast meal Dose was individually adjusted for duration of 26 weeks
Control Intervention1: Insulin Glargine: Injecte
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: -Informed consent obtained before any trial-related activities. -Minimum 18years of age -Must have completed the 26-week treatment period (Visit 28) in trial NN5401-3590
Exclusion criteria
Exclusion criteria: -Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events (AEs)Timepoint: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of severe and minor treatment emergent hypoglycaemic episodesTimepoint: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3590 + 26 weeks of treatment in extension) | — |
Countries
India
Contacts
Public ContactMr Avik Kumar Ghosh
Novo Nordisk India Private Limited.
Outcome results
None listed