Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; sitagliptin; placebo; placebo
Intervention description: For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.; Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.; Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.; For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
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: 1231.0
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
      evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as
      add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes
        and on stable treatment in a period of 90 days prior to screening with either metformin
        above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg
        (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated
        dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses
        as for individual therapies). Stable is defined as unchanged medication and unchanged dose
        - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of
        childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are
        not using an adequate contraceptive method throughout the trial including the 5 weeks
        follow-up period (adequate contraceptive measures as required by local law or practice) -
        Any chronic disorder or severe disease 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 90 days before
        screening. An exception is short-term treatment (below or equal to 7 days in total) with
        insulin in connection with inter-current illness - History of chronic or idiopathic acute
        pancreatitis - Screening calcitonin value above or equal to 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 m2 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