NCT03191396

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide	Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any
DRUG	Liraglutide	Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Timeline

• Start date: 2017-06-27
• Primary completion: 2018-07-09
• Completion: 2018-08-13
• First posted: 2017-06-19
• Last updated: 2019-10-15
• Results posted: 2019-08-28

Locations

92 sites across 12 countries: Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study