Type 2 Diabetes Mellitus (T2D)
Conditions
Brief summary
Change in HbA1c from baseline at Week 30
Detailed description
Change in HbA1c from baseline at Week 30, Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30, Change in fasting plasma glucose from baseline at Week 30, Percent (%) change in body weight from baseline at Week 30, Absolute change in body weight (kg) from baseline at Week 30, Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30, Incidence of AEs, AESIs, and SAEs, Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024), Change in safety laboratory values and vital signs, Change in ECG parameters, Plasma concentrations of RO7795081
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at Week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at Week 30, Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30, Change in fasting plasma glucose from baseline at Week 30, Percent (%) change in body weight from baseline at Week 30, Absolute change in body weight (kg) from baseline at Week 30, Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30, Incidence of AEs, AESIs, and SAEs, Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024), Change in safety laboratory values and vital signs, Change in ECG parameters, Plasma concentrations of RO7795081 | — |
Countries
Hungary, Poland, Spain