Comparison of Switching to Premixed Insulin With Add-on Rapid-acting Insulin in Poorly Controlled Type 2 Diabetes Treated With Basal Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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
干预措施: switch twice-daily insulin (Drug)
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.
干预措施: switch twice-daily insulin (Drug)
结局指标
主要结局
HbA1c
时间窗: 24week duration
To compare the change in HbA1c from baseline to endpoint for each groups at Week 24
次要结局
- weight change(24 weeks duration)
- plasma glucose(24 week duration)
- total insulin dose(24 weeks duration)
- achieving goal percentage(24weeks duration)
- incidence of hypoglcyemia(24 weeks duration)
研究者
Sung-Chen Liu
Mackay Memorial Hospital
Mackay Memorial Hospital