Clinical trial NCT02219750: Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients
Official title: Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: premix insuiln, basal-plus insulin
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: HbA1c
timeFrame: 24week duration
Secondary outcomes:
measure: achieving goal percentage
timeFrame: 24weeks duration
measure: plasma glucose
timeFrame: 24 week duration
measure: weight change
timeFrame: 24 weeks duration
measure: incidence of hypoglcyemia
timeFrame: 24 weeks duration
measure: total insulin dose
timeFrame: 24 weeks duration
Other outcomes:
measure: C peptide
timeFrame: 24weeks
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memerial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Sung-Chen Liu, master
role: PRINCIPAL_INVESTIGATOR
References: