Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30
Intervention description: Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 348.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial was conducted in Asia, Europe and South America. The aim of this trial was to
      confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin
      aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in
      glycosylated haemoglobin (HbA1c).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening)

          -  Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1
             (screening)

          -  Stable treatment (no change in dose or regimen) with a total daily dose of at least
             1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD
             treatment. The metformin treatment must have been stable for at least 2 months prior
             to Visit 1 (screening)

          -  HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week
             of screening visit was allowed. The last sample was to be conclusive)

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m^2

          -  Able and willing to eat at least 2 main meals each day during the trial

          -  Able and willing to adhere to the protocol including compliance with performance of
             self measured plasma glucose (SMPG), injection regimen and titrating themselves
             according to the protocol

          -  Experience in performing self measured plasma glucose (SMPG)

        Exclusion Criteria:

          -  Treatment with any thiazolidinedione (TZD) and glucagon-like peptide-1 (GLP-1)
             receptor agonists or pramlintide within the last 3 months prior to Visit 1 (screening)

          -  Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to
             2.5 times upper referenced limit (one re-test within one week of screening visit was
             allowed. The last sample was to be conclusive)

          -  Impaired kidney function with serum creatinine above or equal to 133 micromol/L (1.5
             mg/dL) for males and above or equal to 124 micromol/L (1.4 mg/dL) for females (one
             re-test within one week of screening visit was allowed. The last sample was to be
             conclusive)

          -  Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as
             systolic blood pressure higher or equal to 180 mmHg and/or diastolic blood pressure
             higher or equal to 100 mmHg)

          -  Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed
             human preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin
             products was allowed only in case of hospitalisation or a severe condition requiring
             intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive
             days, but not during the last 3 months prior to screening visit (Visit 1)