effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin

Conditions: Metabolism and Nutrition Disorder; Obesity

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