The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/liraglutide; placebo
Intervention description: Injected subcutaneously (under the skin) once daily. Dose individually adjusted.; Injected subcutaneously (under the skin) once daily.
Intervention MeSH terms: Liraglutide; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 435.0
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
      this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in
      insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in
      combination with metformin. All subjects will continue their pre-trial SU treatment with or
      without metformin treatment without changing the frequency or dose throughout the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes mellitus

          -  HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)

          -  Subjects on stable daily dose of sulphonylurea (above or equal to half of the max
             approved dose according to local label) with or without metformin (above or equal to
             1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)

          -  Body Mass Index (BMI) below or equal to 40 kg/m^2

        Exclusion Criteria:

          -  Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in
             combinationwith metformin) below or equal to 90 days prior to screening visit (Visit
             1)

          -  Use of any drug (other than SU in monotherapy or in combination with metformin), which
             in the Investigators opinion could interfere with the blood glucose level (e.g.
             systemic corticosteroids)

          -  Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g.
             exenatide, liraglutide)

          -  Treatment with any insulin regimen (short term treatment due to intercurrent illness
             including gestational diabetes is allowed at the discretion of the Investigator)

          -  Screening calcitonin above or equal to 50 ng/l

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia type 2 (MEN2)

          -  Cardiovascular disorders defined as: congestive heart failure (New York Heart
             Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral
             stroke and/or myocardial infarction within the past 52 weeks prior to screening visit
             (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation
             procedures

          -  Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema)
             according to the Investigator's opinion

          -  Subjects with a clinical significant, active (during the past 12 months) disease of
             the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes
             Mellitus),neurological, genitourinary or haematological system that in the opinion of
             the Investigator,may confound the results of the trial or pose additional risk in
             administering trial product

          -  History of chronic pancreatitis or idiopathic acute pancreatitis