Diabetes Type 2
Conditions
Brief summary
Change in glycated haemoglobin (HbA1c), Change in mean 7-point SMPG profiles, Change in mean post‑prandial glucose increment (over all meals), Change in fasting plasma glucose (FPG)
Detailed description
Number of severe hypoglycaemic episodes (level 3), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 milligrams Per Deciliter (mg/dL)), confirmed by blood glucose (BG) meter), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Change in body weight, Relative change in weekly insulin icodec dose
Interventions
DRUGSemaglutide B 1.34 mg/ml PDS290
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycated haemoglobin (HbA1c), Change in mean 7-point SMPG profiles, Change in mean post‑prandial glucose increment (over all meals), Change in fasting plasma glucose (FPG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of severe hypoglycaemic episodes (level 3), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 milligrams Per Deciliter (mg/dL)), confirmed by blood glucose (BG) meter), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Change in body weight, Relative change in weekly insulin icodec dose | — |
Countries
Czechia, Poland
Outcome results
None listed