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

NCT ID: NCT02219750

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-08-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preprandial premix therapy

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

Group Type: ACTIVE_COMPARATOR

switch twice-daily insulin

Intervention Type: DRUG

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

Basal-plus 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.

Group Type: ACTIVE_COMPARATOR

switch twice-daily insulin

Intervention Type: DRUG

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

Interventions

switch twice-daily insulin

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

Intervention Type: DRUG

Other Intervention Names

NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung-Chen Liu

Mackay Memorial Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Chen Liu, master

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Mackay Memerial Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

13MMHISO71,13MMHISO72

Identifier Type: -

Identifier Source: org_study_id