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)
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide 0.5 mg; Semaglutide 1.0 mg; Sitagliptin placebo; Sitagliptin; Semaglutide placebo 0.5 mg; Semaglutide placebo 1.0 mg
Intervention description: Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks; Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks; Sitagliptin placebo tablets taken once-daily for 30 weeks; 100 mg sitagliptin tablets taken once-daily for 30 weeks; Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks; Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 868.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial - Male or female, age equal to
        or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2
        diabetes and on stable treatment in a period of 60 days prior to screening with metformin
        equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is
        defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91
        mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or
        intends to become pregnant or is of childbearing potential not using an adequate
        contraceptive method throughout the trial including the 5 week follow-up period (adequate
        contraceptive measure as required by local regulation or practice) - Any disorder which, in
        the opinion of the investigator, might jeopardise subject's safety or compliance with the
        protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion
        criteria in a period of 60 days before screening. An exception is short-term treatment
        (equal to or below 7 days in total) with insulin in connection with inter-current illness -
        History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to
        or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC)
        or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined
        as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of
        diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or
        cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart
        Association (NYHA) class IV