A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin degludec; Insulin glargine
Intervention description: For subcutaneous (s.c., under the skin) injection once daily; For subcutaneous (s.c., under the skin) injection once daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1609.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and North America. The aim of the trial is to compare the
      efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with
      type 2 diabetes mellitus inadequately treated with basal insulin with or without oral
      antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended
      to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.
    

Eligibility criteria:

        Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing
        informed consent. - Subjects fulfilling at least one of the below criteria (For this
        inclusion criterion the aim is to include minimum 80% of individuals with a previous
        episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least
        one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within
        the last year (according to the ADA definition, April 2013 (An episode requiring assistance
        of another person to actively administer carbohydrate, glucagon, or take other corrective
        actions. Plasma glucose concentrations may not be available during an event, but
        neurological recovery following the return of plasma glucose to normal is considered
        sufficient evidence that the event was induced by a low plasma glucose concentration.). -
        b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59
        mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom
        unawareness (History of impaired autonomic responses (tremulousness, sweating,
        palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5
        years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode
        with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L]))
        within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically)
        with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily
        insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100
        U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of
        screening with or without any of the following anti-diabetic drugs with stable doses for
        equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4
        inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors
        (acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including
        the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at
        screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion
        Criteria: - Treatment with any medication for the indication of diabetes or obesity other
        than stated in the inclusion criteria in a period of 90 days before the day of screening