Health Condition 1: null- Type 2 diabetes inadequately controlled with basal insulin Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: NovoMix®30
: 24 weeks, twice daily, sub-cutaneous(s.c)
The total daily dose of pre-trial basal insulin should be transferred to the total daily starting dose of
BIAsp 30 by unit-to-uni
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, age >= 18 years at the time of signing informed consent 2. Type 2 diabetes subjects clinically diagnosed >= 12 months prior to the day of screening (Visit 1) 3. Treated with basal insulin >= 90 days prior to the day of screening (Visit 1). The following basal insulin are allowed : â?? insulin analogue once daily (OD) â?? Neutral Protamine Hagedorn (NPH) OD or BID 4. Treatment with metformin with or without one additional OAD for at least 90 days prior to the day of screening (Visit 1) o Metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (Visit 1) â?? One additional OAD: o Sulphonylurea o Glinides o α-glucosidase inhibitors o Dipeptidyl-peptidase-4 inhibitors o Sodium glucose co-transporter 2 (SGLT2) inhibitors (if applicable) 5. HbA1c 7.5%â??10.0% (both inclusive) by central laboratory analysis at screening (Visit 1) 6. Able and willing to intake three main meals daily (breakfast, lunch and main evening meal) throughout the trial. Definition of main meal as judged by the investigator
Exclusion criteria
Exclusion criteria: 1. Previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily, basal-bolus regimen or continuous subcutaneous insulin infusion (CSII). Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days 2. Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, systemic corticosteroids) 3. Impaired liver function, defined as alanine aminotransferase (ALT) >= 2.5 times upper normal limit at screening (Visit 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in glycosylayed haemoglobin (HbA1c) after 24 weeks of treatment Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| "1. Proportion of subjects achieving HbA1c 7.0% without severe hypoglycaemic episodes after 24 weeks of treatment Timepoint: 24 weeks;2. Number of treatment emergent hypoglycaemic episodes classified according to the American Diabetes Association (ADA) and Novo Nordisk definition during 24 weeks of treatmentTimepoint: 24 weeks | — |
Countries
Algeria, China, Hong Kong, India, Taiwan, Turkey, Ukraine
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed