NCT04707469

Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes

Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,606 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Oral semaglutide	Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.

Timeline

• Start date: 2021-01-15
• Primary completion: 2023-03-07
• Completion: 2023-03-08
• First posted: 2021-01-13
• Last updated: 2025-12-09
• Results posted: 2024-04-03

Locations

228 sites across 15 countries: United States, Australia, Bulgaria, Canada, Croatia, Czechia, Estonia, Germany, Hungary, India, Poland, Puerto Rico, Slovakia, Slovenia, Taiwan

Regulatory

• FDA-regulated drug study