Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; biphasic insulin aspart 30; sitagliptin; metformin
Intervention description: BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.; BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.; Subjects will continue on their pre-trial sitagliptin treatment.; Subjects will continue on their pre-trial metformin treatment.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Sitagliptin Phosphate; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 582.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical
      trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30
      (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various
      regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or
      without other oral anti-diabetic drugs (OADs)).

      The trial is conducted as a phase 4 trial in the majority of the participating countries.
      However, in some countries the trial is conducted as phase 3b.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)

          -  Stable treatment with a total daily dose of at least 1000 mg of metformin (with or
             without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must
             have been unchanged for at least 3 months prior to screening (Visit 1)

          -  Stable treatment with a total daily dose of at least 100 mg sitagliptin. The
             sitagliptin dose must have been unchanged for at least 3 months prior to screening
             (Visit 1)

          -  Subject is insulin-naïve (never previously treated with insulin). (However, short term
             insulin use due to intermittent illness of up to 14 days or insulin treatment for
             gestational diabetes is allowed)

          -  HbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both
             inclusive) by central laboratory analysis demonstrating inadequate control on
             sitagliptin and metformin (with or without other OADs)

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m^2

          -  Able and willing to eat at least 2 meals (breakfast and dinner) every day during the
             trial

        Exclusion Criteria:

          -  Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor
             agonist within the last 3 months prior to screening (Visit 1)

          -  Cardiac disease within the last 6 months prior to screening (Visit 1), defined as:
             decompensated heart failure New York Heart Association (NYHA) class III or IV;
             unstable angina pectoris; or myocardial infarction

          -  Severe hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic
             blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting
             position using mean value of 3 measurements at screening (Visit 1)

          -  Anticipated change of dose of any systemic treatment with products, which in the trial
             physician's opinion could interfere with glucose metabolism (e.g., systemic
             corticosteroids)

          -  Clinically significant diseases (except for conditions associated with type 2
             diabetes) which, in the trial physician's opinion may confound the results of the
             trial or pose additional risk in administering trial product(s)

          -  Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine
             aminotransferase (ALAT) above 2.5 times the upper normal range, according to central
             laboratory reference ranges

          -  Impaired renal function as indicated by serum creatinine levels equal to or above 133
             micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for
             females or estimated creatinine clearance below 60 mL/min, based on the Cockroft &
             Gault formula and according to local practise for metformin use