Diabetes
Conditions
Keywords
premix insuiln, basal-plus insulin
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.
Interventions
DRUGswitch 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
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 24week duration | To compare the change in HbA1c from baseline to endpoint for each groups at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| achieving goal percentage | 24weeks duration | To compare the proportion of patients achieving HbA1c \< 7% at Week 24. |
| plasma glucose | 24 week duration | To compare the changes in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) at Week 24. |
| incidence of hypoglcyemia | 24 weeks duration | To evaluate the incidence of self-reported hypoglycemia episodes. |
| total insulin dose | 24 weeks duration | To estimate total insulin dose. |
| weight change | 24 weeks duration | To compare the change in body weight at each visit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| C peptide | 24weeks | to compare serum C peptide between baseline and end of trial |
Countries
Taiwan
Outcome results
None listed