Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin aspart; insulin aspart; insulin detemir
Intervention description: Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c.
Doses individually adjusted.; Insulin aspart added before each main meal. Doses individually adjusted.; Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, and North and South America. The aim of this clinical
      trial is to investigate if the two treatments are equally effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes (diagnosed clinically) for at least 12 months

          -  Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or
             insulin detemir once daily) for at least 6 months

          -  HbA1c: 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed
             at the central laboratory within a week is permitted with the result of the last
             sample being conclusive)

          -  BMI (Body Mass Index) less than 40.0 kg/m^2

        Exclusion Criteria:

          -  Previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin
             only in case of a hospitalisation or a severe condition requiring intermittent use of
             bolus insulin for less than 14 consecutive days, but not during the last 6 months
             prior to screening visit (Visit 1)

          -  Use of GLP-1 (Glucagon-like peptide-1) receptor agonists or pramlintide within the
             last 6 months prior to prior to screening visit (Visit 1)

          -  Anticipated change in concomitant medication known to interfere significantly with
             glucose metabolism (e.g. systemic corticosteroids, beta-blockers, MAO (Monoamine
             oxidase) inhibitors, etc.)

          -  Cardiovascular disease, within the last 12 months prior to screening visit (Visit 1),
             defined as: stroke; decompensated heart failure New York Heart Association (NYHA)
             class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial
             bypass graft or angioplasty

          -  Uncontrolled treated/untreated severe hypertension (systolic blood pressure sitting at
             least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100
             mmHg). For Argentina: systolic blood pressure sitting at least 150 mmHg and/or
             diastolic blood pressure at least 90 mmHg

          -  Impaired liver function, defined as ALAT (Alanine aminotransferase) at least 2.5 times
             upper limit of normal (one retest analysed at the central laboratory within a week is
             permitted with the result of the last sample being conclusive)

          -  Impaired renal function defined as serum creatinine above 135 micromol/L (above 1.5
             mg/dL) for males and above 110 micromol/L (above 1.2 mg/dL) for females; and, if
             required by the locally applicable metformin label, glomerular filtration rate below
             60 ml/min, calculated by the Cockroft & Gault formula). One retest within a week is
             permitted with the result of the last sample being conclusive

          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the
             last 12 months) or hypoglycaemic unawareness as judged by the Investigator or
             hospitalisation for diabetic ketoacidosis during the previous 6 months

          -  Proliferative retinopathy or maculopathy requiring treatment according to the
             Investigator

          -  Treatment with OADs (Oral anti-diabetic drug) contraindicated or unapproved for
             combination treatment with insulin (according to local OAD label)