Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 6
- 主要终点
- To compare the change in HbA1c between two study groups at Week 24.
研究概览
简要总结
This study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by OADs.
详细描述
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir 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.
Inclusion criteria:
Patients must meet all of the following criteria:
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria:
- •Men and women with type 2 diabetes.
- •20 years of age.
- •Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- •Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- •Patients who are willing and able to cooperate with study and give signed informed consent.
排除标准
- •Patients with type 1 diabetes.
- •Renal dialysis patients.
- •History of hypoglycemia unawareness.
- •Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
- •Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
- •Patients hypersensitive with insulin detemir or its excipients.
- •Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.
研究组 & 干预措施
Active titration algorithm
titrate insulin dose by contacting with investigator by telephone weekly.
干预措施: Active titration algorithm (Behavioral)
Usual titration algorithm
contact with investigator only at routine study visit.
干预措施: Usual titration algorithm (Behavioral)
结局指标
主要结局
To compare the change in HbA1c between two study groups at Week 24.
时间窗: 24 weeks
compare the change in HbA1c between two study groups after 24 weeks treatment.
次要结局
- To compare the proportion of patients achieving HbA1C <7% at Week 24(24 weeks)
- To evaluate the incidence of adverse events.(24 weeks)
- To compare the change in HbA1C between two study groups at Week 12.(12 weeks)
- To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.(24 weeks)
- To compare the change in body weight at each visit(24 weeks)
研究者
Sung-Chen Liu
Division of Endocrinology and Metabolism, Department of Internal Medicine
Mackay Memorial Hospital