Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 140 patients with type 2 diabetes from Mackay Memorial Hospitals and Mackay Memorial Hospital Taitung branch. After enrollment, eligible patients will be randomized in a 1:1 ratio to either Basal-plus therapy(BPT) or Preprandial premix therapy(PPT). The effectiveness of advancing insulin therapy will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period. All study procedure will be conducted after obtaining informed consent.

Inclusion Criteria:

• Men and women with type 2 diabetes.(World Health Organization classification) > 20 years of age.
• Patients who have received stable doses of any OADs for at least 12 weeks prior to the screening visit.
• treatment with basal insulin plus OADs >3 months with suboptimal glycemic control (HbA1c >7%)
• FBG <130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose >0.7U/kg or had history of nocturnal hypoglycemia
• Patients who are willing and able to cooperate with study and give signed informed consent.

Exclusion Criteria:

• Patients with type 1 diabetes.
• History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.
• Patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit.
• Patients hypersensitive with insulin analog or its excipients.
• Patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation.
• Renal dialysis patients, patients with severe liver disease or congestive heart failure
• BMI >40kg/m2
• Excessive insulin resistance (total daily insulin dose>2.0unit/kg)