Type of study, patients, and inclusion criteria
- Phase 2b, randomised, double-blind study at 47 sites.
- Patients with T2D were randomly assigned (1:1:1:1:1:1) to receive either once-weekly subcutaneous LY3298176 (1 mg, 5 mg, 10 mg, or 15 mg), once-weekly dulaglutide (1.5 mg), or placebo for 26 weeks.
- Total number of enrolees: 318.
- Age: 18-75 years.
- Duration of follow-up: 26 weeks.
- Eligible participants (aged 18-75) had T2D for at least 6 months (HbA1c 7.0-10.5%, inclusive) that was inadequately controlled with diet and exercise alone or with stable metformin therapy for at least 3 months before screening, and BMI of 23-50 kg/m2.
- Change in HbA1c from baseline to 26 weeks in the modified intention-to-treat (mITT) population (all patients who received at least one dose of study drug and had at least one postbaseline measurement of any outcome).
Secondary outcome measures:
- Change in HbA1c from baseline to 12 weeks.
- Change in mean bodyweight, fasting plasma glucose, waist circumference, total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides.
- Proportion of patients reaching HbA1c target (≤6.5% and <7.0%) from baseline to weeks 12 and 26.
- Proportion of patients with at least 5% and 10% bodyweight loss from baseline to 26 weeks.