Status:
COMPLETED
Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Diabetes
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 Ta...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT02219750
Start Date
August 1 2013
End Date
August 1 2016
Last Update
August 17 2018
Active Locations (1)
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1
Mackay Memerial Hospital
Taipei, Taiwan