Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients
- Conditions
- Diabetes
- Interventions
- Drug: switch twice-daily insulin
- Registration Number
- NCT02219750
- Lead Sponsor
- Mackay Memorial Hospital
- Brief Summary
Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Preprandial premix therapy switch twice-daily insulin switch twice-daily insulin Preprandial premix therapy mean that transition of advance insulin based on the basal insulin daily total dose at study entry divided into two equal dose of preprandial NovoMix 30. Patient discontinued all pre-study oral antidiabetic drug(OAD), including sulfonylureas, glinides, Thiazolidinedione(TZD) and Dipeptidyl peptidase-4(DPP-4) inhibitor but left metformin alone Basal-plus insulin switch twice-daily insulin switch twice-daily insulin Basal-plus insulin consisted of continued previous basal insulin and add-on once-daily insulin aspart(NovoRapid) before breakfast. The starting dose of insulin aspart was 4 unit(U) before breakfast and continued under previous basal insulin dose.
- Primary Outcome Measures
Name Time Method HbA1c 24week duration To compare the change in HbA1c from baseline to endpoint for each groups at Week 24
- Secondary Outcome Measures
Name Time Method plasma glucose 24 week duration To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.
weight change 24 weeks duration To compare the change in body weight at each visit.
total insulin dose 24 weeks duration To estimate total insulin dose.
achieving goal percentage 24weeks duration To compare the proportion of patients achieving HbA1c \< 7% at Week 24.
incidence of hypoglcyemia 24 weeks duration To evaluate the incidence of self-reported hypoglycemia episodes.
Trial Locations
- Locations (1)
Mackay Memerial Hospital
🇨🇳Taipei, Taiwan