NCT04017832

A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,441 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Oral semaglutide	Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
DRUG	Sitagliptin	Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
DRUG	Placebo (oral semaglutide)	Placebo tablet to be taken first thing in the morning
DRUG	Placebo (sitagliptin)	Placebo tablet to be taken 30 minutes after oral semaglutide

Timeline

• Start date: 2019-07-29
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2019-07-12
• Last updated: 2024-10-01
• Results posted: 2023-09-29

Locations

93 sites across 9 countries: Algeria, Brazil, China, Czechia, Hong Kong, Romania, Serbia, South Africa, Taiwan