Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Nutrition Disorders
Intervention: Liraglutide 3.0 mg; Placebo
Intervention description: Injected subcutaneously (s.c., under the skin) once daily; Injected subcutaneously (s.c., under the skin) once daily
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate effect and safety
      of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus
      treated with basal insulin.
    

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 - Diagnosed with type 2
        diabetes mellitus - Treatment with up to 2 OADs (oral anti-diabetic) (metformin, glitazone,
        SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) or sulphonylurea) - Stable
        treatment with basal insulin according to its label (no requirement of minimum or maximum
        dose) for at least 90 days prior to screening, as judged by the investigator - HbA1c
        (glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or
        above 27 kg/m^2 - Age at least 18 years at the time of signing informed consent Exclusion
        Criteria: - Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by
        the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) -
        Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
        - Unable or unwilling to perform self-monitoring of plasma glucose according to the
        protocol and to keep a diabetes diary - Treatment with any hypoglycaemic medications other
        than OADs and basal insulin within the past 90 days prior to screening - Treatment with a
        DPP-IV (dipeptidyl peptidase-4) inhibitor within the past 90 days prior to screening -
        Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6
        months), severe congestive heart failure (NYHA class III, IV), or second degree or greater
        heart block - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple
        Endocrine Neoplasia type 2 (MEN2) - Female who is pregnant, breast-feeding or intends to
        become pregnant or is of child-bearing potential and not using an adequate contraceptive
        method (adequate contraceptive measure as required by local regulation or practice) - For
        Germany: Only highly effective methods of birth control are accepted (i.e. 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 - Use in past 90 days of medications known to induce
        significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g.,
        chronic use of oral steroids, second generation antipsychotics) - History of pancreatitis
        (acute or chronic) - History of major depressive disorder within the past 2 years - Any
        lifetime history of a suicide attempt - Inadequately treated blood pressure defined as
        Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or
        equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the
        past 5 years