A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/liraglutide; insulin glargine
Intervention description: IDegLira will be given subcutaneously ( s.c., under the skin) once daily.; IGlar will be given subcutaneously ( s.c., under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Liraglutide; Xultophy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is comparing glycaemic control and
      safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on
      therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2
      diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
        consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0%
        [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI)
        equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short
        term insulin treatment for a maximum of 14 days prior to the day of screening is allowed,
        as well as prior insulin treatment for gestational diabetes - A stable daily dose for at
        least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination
        with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects
        treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal
        product within 90 days prior to screening - Use of any OADs (other than SGLT2i in
        monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the
        inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like
        peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to
        the day of screening - Acute decompensation of glycaemic control requiring immediate
        intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes
        ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects
        presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal
        impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic
        Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT
        (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening -
        Known or suspected hypersensitivity to trial product(s) or related products