Obesity, Diabetes mellitus type II
Conditions
Brief summary
Percentage change in body weight from baseline to Week 76, Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Detailed description
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76, Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76, Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76, Absolute change from baseline to Week 76 in: o Body weight (kg) o HbA1c (%) o Waist circumference (cm) o SBP (mmHg) o “Capacity to Resist” domain score of Eating Behaviour PRO (units on scale) o Eating Behaviour PRO total score (units on scael)
Interventions
DRUGBI 456906
DRUGPlacebo
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline to Week 76, Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76, Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76, Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76, Absolute change from baseline to Week 76 in: o Body weight (kg) o HbA1c (%) o Waist circumference (cm) o SBP (mmHg) o “Capacity to Resist” domain score of Eating Behaviour PRO (units on scale) o Eating Behaviour PRO total score (units on scael) | — |
Countries
Belgium, Czechia, Denmark, Finland, Germany, Greece, Hungary, Netherlands, Poland, Spain, Sweden
Outcome results
None listed