NCT03061214

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes. A 30-week Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-centre and Multi-national Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 868 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide 0.5 mg	Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks
DRUG	Semaglutide 1.0 mg	Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks
DRUG	Sitagliptin placebo	Sitagliptin placebo tablets taken once-daily for 30 weeks
DRUG	Sitagliptin	100 mg sitagliptin tablets taken once-daily for 30 weeks
DRUG	Semaglutide placebo 0.5 mg	Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks
DRUG	Semaglutide placebo 1.0 mg	Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks

Timeline

• Start date: 2017-08-28
• Primary completion: 2019-03-14
• Completion: 2019-04-15
• First posted: 2017-02-23
• Last updated: 2021-03-02
• Results posted: 2020-04-09

Locations

67 sites across 7 countries: Brazil, China, Hong Kong, South Africa, South Korea, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study