Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; biphasic insulin aspart 30
Intervention description: Dose individually adjusted by the subjects themselves according to the titration algorithm every second week. Administered subcutaneously (s.c., under the skin) twice daily.; Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; 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: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa and Asia. The aim of the trial is to compare
      patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in
      type 2 diabetes patients uncontrolled on NPH insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening

          -  Currently treated with a NPH insulin for at least 3 months prior to 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 screening

          -  HbA1c between 7.0% and 10.0% (both inclusive). (One re-test within one week of
             screening visit is allowed. The last sample will 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 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 is
             allowed. The last sample will be conclusive.)

          -  Impaired kidney function with serum creatinine above or equal to 133 µmol/L (1.5
             mg/dL) for males and above or equal to 124 µmol/L (1.4 mg/dL) for females. (One
             re-test within one week of screening visit is allowed. The last sample will be
             conclusive.)

          -  Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as
             systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure
             above or equal to 100 mmHg)

          -  Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed
             human preparations)

          -  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

          -  Known proliferative retinopathy or maculopathy requiring treatment