Health Condition 1: null- Diabetes Mellitus, Type I Health Condition 2: E10- Type 1 diabetes mellitus
Conditions
Interventions
Intervention1: NN1250: NN1250 injected subcutaneously (under the skin) once daily.The dose will be individually adjusted.
Drug: insulin aspart. Insulin aspart injected subcutaneously (under the skin)
).: Insulin detemir (Levemir®
)injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
Control Intervention2: Insulin aspart.: Insulin aspart injected subcutaneously (under the skin) as mealti
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: Type 1 diabetes mellitus for at least 12 months Current treatment with any basal bolus insulin for at least 12 months HbA1c below or equal to 10.0 % BMI (body mass index) below or equal to 35.0 kg/m2 Age 18 years and older
Exclusion criteria
Exclusion criteria: Use of any other antidiabetic drug than insulin within the last 3 months Cardiovascular disease within the last 6 months Uncontrolled treated/untreated severe hypertension Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures Cancer and medical history of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1cTimepoint: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG)Timepoint: After 26 weeks of treatment ;Number of hypoglycaemic episodesTimepoint: Over 26 weeks of treatment ;Plasma glucose profilesTimepoint: After 26 weeks of treatment. | — |
Countries
India
Contacts
Public ContactMr Avik Kumar Ghosh
Novo Nordisk India Private Limited. Novo Nordisk India Private Limited.
Outcome results
None listed