Health Condition 1: E08-E13- Diabetes mellitus Health Condition 2: null- Diabetes Mellitus, Type 2.
Conditions
Interventions
Intervention1: NN5401: NN5401 injected subcutaneously (under the skin) once daily with main meal. The dose will be individually adjusted.
Control Intervention1: Insulin glargine: Insulin glargine inj
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus for at least 6 months Ongoing daily treatment with a basal insulin (insulin detemir, insulin glargine, or insulin NPH) once daily for at least 3 months Ongoing treatment with metformin with our without other OADs (oral anti-diabetic drugs) for at least 3 months HbA1c 7.0 ? 10.0 % (both inclusive) BMI (Body Mass Index) at most 40.0 kg/m2 Age 18 Years and older
Exclusion criteria
Exclusion criteria: Treatment with other insulin regimens than those listed in key inclusion criterion within the last 3 months Treatment with rosiglitazone, or GLP-1 receptor agonists within the last 3 months Significant cardiovascular disease within the last 6 months Uncontrolled treated/untreated severe hypertension Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures Impaired liver or renal function Cancer and medical history of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change from baselineTimepoint: After 26 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma glucose profilesTimepoint: After 26 weeks of treatment | — |
Countries
Croatia, France, India, Poland, Republic of Korea, South Africa, Sweden, Turkey, United States of America
Contacts
Public ContactMr Avik Kumar Ghosh
Novo Nordisk India Private Limited.
Outcome results
None listed