Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects 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
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®.
Inclusion Criteria:
Male or female, age above or equal to 18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
BMI equal to or above 25 kg/m^2
Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:
Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Exclusion Criteria:
Plzeň 3, 301 00, Czechia
Budapest, Pest County 1036, Hungary
Hyderabad, Andhra Pradesh 500034, India
New Delhi, National Capital Territory of Delhi 110088, India
New Dehli, New Delhi 110029, India
Gorzów Wielkopolski, Lubusz Voivodeship 66-400, Poland
Bialystok, Podlaskie Voivodeship 15-435, Poland
Krakow, 30-688, Poland