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

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

Detailed Description
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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.

Official Title
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Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin

Conditions
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Diabetes

Intervention / Treatment
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* Drug: switch twice-daily insulin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preprandial premix therapy<br>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 | Drug: switch twice-daily insulin<br>* 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<br>* Other names: NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®;|
| Active Comparator: Basal-plus insulin<br>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. | Drug: switch twice-daily insulin<br>* 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<br>* Other names: NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | To compare the change in HbA1c from baseline to endpoint for each groups at Week 24 | 24week duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| achieving goal percentage | To compare the proportion of patients achieving HbA1c < 7% at Week 24. | 24weeks duration | 
| plasma glucose | To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24. | 24 week duration | 
| weight change | To compare the change in body weight at each visit. | 24 weeks duration | 
| incidence of hypoglcyemia | To evaluate the incidence of self-reported hypoglycemia episodes. | 24 weeks duration | 
| total insulin dose | To estimate total insulin dose. | 24 weeks duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premix insuiln, basal-plus insulin