MedTrace Logo

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)

NCT03061214 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 868

Last updated 2021-03-02

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2019-03-14
Completion
2019-04-15
FDA Drug
Yes

Countries

  • Brazil
  • China
  • Hong Kong
  • South Africa
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061214 on ClinicalTrials.gov