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

Diabetes Clinical Trial

— COMPAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219750
• Other study ID #: 13MMHISO71,13MMHISO72
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: August 2016

Study information

• Verified date: March 2016
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Taiwan	Mackay Memerial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C peptide	to compare serum C peptide between baseline and end of trial	24weeks
Primary	HbA1c	To compare the change in HbA1c from baseline to endpoint for each groups at Week 24	24week duration
Secondary	achieving goal percentage	To compare the proportion of patients achieving HbA1c < 7% at Week 24.	24weeks duration
Secondary	plasma glucose	To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24.	24 week duration
Secondary	weight change	To compare the change in body weight at each visit.	24 weeks duration
Secondary	incidence of hypoglcyemia	To evaluate the incidence of self-reported hypoglycemia episodes.	24 weeks duration
Secondary	total insulin dose	To estimate total insulin dose.	24 weeks duration