Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; placebo
Intervention description: Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.; Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as
      add-on to basal insulin alone or basal insulin in combination with metformin in subjects with
      type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform
        consent. For Japan: Male or female, age at least 20 years at the time of signing informed
        consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes
        treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of
        0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec
        and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or
        maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin)
        7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive Exclusion Criteria: - Female who is
        pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and
        not using an adequate contraceptive method throughout the trial including the 5 weeks
        follow-up period (adequate contraceptive measures as required by local regulation or
        practice). Germany: Only highly effective methods of birth control are accepted (ie one
        that results in less than 1% per year failure rate when used consistently and correctly
        such as implants, injectables, combined oral contraceptives, some intrauterine device), or
        sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are
        abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device,
        sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents
        other than stated in the inclusion criteria in a period of 90 days before screening. An
        exception is short-term treatment (7 days or less in total) with bolus insulin in
        connection with intercurrent illness - Experienced more than 3 episodes of severe
        hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness -
        History of pancreatitis (acute or chronic) - 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 2 (MEN 2) - Severe renal impairment defined as eGFR
        (estimated glomerular filtration rate) below 30 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