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)

Sponsor
Novo Nordisk A/S
Study ID
NCT03061214
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 28, 2017
Status verified
Feb 2021
Primary completion
Mar 14, 2019
Completion
Apr 15, 2019

Study Design

Enrollment
868 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 0.5 mg OW + sitagliptin placebo OD
  • Experimental: Semaglutide 1 mg OW + sitagliptin placebo OD
  • Active Comparator: Sitagliptin OD + semaglutide placebo 0.5 mg OW
  • Active Comparator: Sitagliptin OD + semaglutide placebo 1 mg OW

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 0, week 30 ]

Related Studies