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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02219750
• Date of registration: 14/08/2014
• Prospective Registration: No
• Primary sponsor: Mackay Memorial Hospital
• Public title: Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients COMPAR
• Scientific title: Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
• Date of first enrolment: August 2013
• Target sample size: 181
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02219750
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: Sung-Chen Liu, master
• Affiliation: Mackay Memorial Hospital

Key inclusion & exclusion 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)



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Drug: switch twice-daily insulin

Primary Outcome(s)

HbA1c [Time Frame: 24week duration]

Secondary Outcome(s)

achieving goal percentage [Time Frame: 24weeks duration]

incidence of hypoglcyemia [Time Frame: 24 weeks duration]

total insulin dose [Time Frame: 24 weeks duration]

plasma glucose [Time Frame: 24 week duration]

weight change [Time Frame: 24 weeks duration]

Secondary ID(s)

13MMHISO71,13MMHISO72

Source(s) of Monetary Support

Please refer to primary and secondary sponsors