A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin degludec/insulin aspart; Insulin glargine; Insulin aspart
Intervention description: Administered subcutaneously (s.c. under the skin) once daily.; Administered subcutaneously (s.c. under the skin) once daily.; Administered subcutaneously (s.c. under the skin) once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 532.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine
      plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or
      without oral antidiabetic treatment in need of treatment intensification.
    

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 at least 18 years at the time of signing informed consent Algeria:
             Male or female, age at least 19 years at the time of signing informed consent

          -  Diagnosed with type 2 diabetes mellitus

          -  Treated with any basal insulin for at least 90 days prior to the day of screening

          -  Subject not on any OAD(s) prior to trial participation OR subjects on stable daily
             dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s)
             include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin
             at least 1500 mg or maximum tolerated dose documented in the subject medical record)
             b. Other OADs (at least half of the maximum approved dose according to local label or
             maximum tolerated dose as documented in subject medical record): i. Insulin
             secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii.
             α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v.
             Oral combination products (of the allowed individual OADs above)

          -  HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis

          -  Body mass index (BMI) equal to or below 45.0 kg/m^2

        Exclusion Criteria:

          -  Participation in any clinical trial of an approved or non-approved investigational
             medicinal product within four weeks prior to the day of screening (V1)

          -  Any chronic disorder or severe disease which, in the opinion of the investigator,
             might jeopardise subject's safety or compliance with the protocol

          -  Acute decompensation of glycaemic control requiring immediate intensification of
             treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal
             or below 90 days prior to the day of the screening and between screening and
             randomisation

          -  Any of the following: myocardial infarction, stroke or hospitalization for unstable
             angina or transient ischaemic attack within the past 180 days prior to the day of
             screening and between screening and randomisation

          -  Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of
             below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope
             dilution mass spectrometry (IDMS) for serum creatinine measured at screening

          -  Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above
             2.5 times upper normal limit (UNL) at screening.

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  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

          -  Anticipated initiation or change in concomitant medications (for more than 14
             consecutive days) known to affect weight or glucose metabolism (e.g. treatment with
             orlistat, thyroid hormones, or corticosteroids)