Type 2 Diabetes
Conditions
Brief summary
Change in HbA1c from baseline week 0 (V6) to week 26 (V32)
Detailed description
Change in time in range 3.9–10.0 mmol/L (70–180 mg/dL), Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction, Number of severe hypoglycaemic episodes (level 3) (safety), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) (safety), 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), Time spent < 3.0 mmol/L (54 mg/dL), Change in time spent > 10.0 mmol/L (180 mg/dL), Mean weekly insulin dose, Change in body weight
Interventions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline week 0 (V6) to week 26 (V32) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in time in range 3.9–10.0 mmol/L (70–180 mg/dL), Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction, Number of severe hypoglycaemic episodes (level 3) (safety), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) (safety), 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), Time spent < 3.0 mmol/L (54 mg/dL), Change in time spent > 10.0 mmol/L (180 mg/dL), Mean weekly insulin dose, Change in body weight | — |
Countries
Bulgaria, Germany, Poland, Spain
Outcome results
None listed