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

Mackay Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: switch twice-daily insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02219750

13MMHISO71,13MMHISO72

Details and patient eligibility

About

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

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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181 participants in 2 patient groups

Preprandial premix therapy

Active Comparator group

Description:

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

Treatment:

Drug: switch twice-daily insulin

Basal-plus insulin

Active Comparator group

Description:

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.

Treatment:

Drug: switch twice-daily insulin