Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mackay Memorial Hospital
• Treatments: Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Detemir; Insulin, Globin Zinc; Insulin, Short-Acting

Criteria

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)