At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Type 2 diabetes diagnosed ≥180 days before screening
- ✓HbA1c 8.0-10.5% (64-91 mmol/mol)
- ✓BMI ≥25 kg/m²
- ✕Diabetes or obesity medication other than those specified in inclusion criteria within 90 days prior to screening (short-term insulin ≤14 days allowed)
- ✕eGFR <30 mL/min/1.73 m² (Chronic Kidney Disease Epidemiology Collaboration creatinine equation)
- ✕Uncontrolled or potentially unstable diabetic retinopathy or maculopathy (fundus exam within 90 days required; pharmacological pupil dilation required unless using non-dilated digital fundus photography camera)
- ✕If on DPP-4 inhibitor at baseline, must discontinue at randomization without washout period
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Oral semaglutide for Diabetes Mellitus, Type 2. Completed, enrolled 1,606 participants across 228 sites in 15 countries.
Detailed Summary
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.
Study Details
Timeline
Interventions
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.