The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/liraglutide; liraglutide; exenatide
Intervention description: Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.; Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.; Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
Intervention MeSH terms: Liraglutide; Exenatide; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 438.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, Oceania and the United States of America (USA).

      The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in
      controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like
      peptide-1 (GLP-1) receptor agonist and OAD therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes mellitus

          -  Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)

          -  Treatment with daily GLP-1 receptor agonist at maximum dose according to local label
             (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID)
             Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza®
             (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable
             daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated
             dose) for 90 days or more prior to screening visit (Visit 1)

          -  BMI (body mass index) equal to or below 40 kg/m^2

        Exclusion Criteria:

          -  Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and
             sulphonylurea) for 90 days or less prior to screening visit (Visit 1)

          -  Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor
             agonist) which in the Investigator's opinion could interfere with the blood glucose
             level (e.g. systemic corticosteroids)

          -  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 equal to or above 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 clinically 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 products

          -  History of chronic pancreatitis or idiopathic acute pancreatitis