LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo
Intervention description: Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks; Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial is conducted in Asia, Europe, North America and South America. The aim of the study
      is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2
      inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes
      mellitus.
    

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.

          -  Male or female, age 18 years or older at the time of signing informed consent.

          -  Diagnosed with type 2 diabetes mellitus.

          -  HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).

          -  Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including
             fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or
             maximum tolerated dose) for at least 90 days prior to the day of screening. All
             medications in compliance with current local label.

          -  Body mass index of 20 kg/m^2 or above.

        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 (adequate
             contraceptive measure as required by local regulation or practice).

          -  History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.

          -  Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less
             than 60 mL/min/1.73m^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO)
             classification using isotope dilution mass spectrometry (IDMS) for serum creatinine
             measured at screening.

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria within the past 90 days prior to the day of
             screening. However, short term insulin treatment for a maximum of 14 days during the
             90 days prior to screening is allowed.

          -  Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
             carcinoma. Family is defined as a first degree relative.

          -  History or presence of pancreatitis (acute or chronic).

          -  Impaired liver function, defined as ALT 2.5 or more times upper normal limit at
             screening.

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV.