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

August 16, 2018 updated by: Sung-Chen Liu, Mackay Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Mackay Memerial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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

Other Names:
  • NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®
Active Comparator: 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.
Drug: 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

Other Names:
  • NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
C peptide
Time Frame: 24weeks
to compare serum C peptide between baseline and end of trial
24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Sung-Chen Liu, master, Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 17, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13MMHISO71,13MMHISO72

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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