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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
181
compare two different insuiln regimen in basal insuln base and premixed insulin. NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin
Mackay Memerial Hospital
Taipei, Taiwan
HbA1c
To compare the change in HbA1c from baseline to endpoint for each groups at Week 24
Time frame: 24week duration
achieving goal percentage
To compare the proportion of patients achieving HbA1c \< 7% at Week 24.
Time frame: 24weeks duration
plasma glucose
To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.
Time frame: 24 week duration
weight change
To compare the change in body weight at each visit.
Time frame: 24 weeks duration
incidence of hypoglcyemia
To evaluate the incidence of self-reported hypoglycemia episodes.
Time frame: 24 weeks duration
total insulin dose
To estimate total insulin dose.
Time frame: 24 weeks duration
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