Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219750
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sung-Chen Liu, Mackay Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Diabetes Drug: switch twice-daily insulin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
Actual Study Start Date : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 24week duration ]
    To compare the change in HbA1c from baseline to endpoint for each groups at Week 24


Secondary Outcome Measures :
  1. achieving goal percentage [ Time Frame: 24weeks duration ]
    To compare the proportion of patients achieving HbA1c < 7% at Week 24.

  2. plasma glucose [ Time Frame: 24 week duration ]
    To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.

  3. weight change [ Time Frame: 24 weeks duration ]
    To compare the change in body weight at each visit.

  4. incidence of hypoglcyemia [ Time Frame: 24 weeks duration ]
    To evaluate the incidence of self-reported hypoglycemia episodes.

  5. total insulin dose [ Time Frame: 24 weeks duration ]
    To estimate total insulin dose.


Other Outcome Measures:
  1. C peptide [ Time Frame: 24weeks ]
    to compare serum C peptide between baseline and end of trial



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219750


Locations
Layout table for location information
Taiwan
Mackay Memerial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sung-Chen Liu, master Mackay Memorial Hospital
Layout table for additonal information
Responsible Party: Sung-Chen Liu, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT02219750    
Other Study ID Numbers: 13MMHISO71,13MMHISO72
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: March 2016
Keywords provided by Sung-Chen Liu, Mackay Memorial Hospital:
premix insuiln, basal-plus insulin
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs