Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin With Pre-mix Insulin Monotherapy for the Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG
研究概览
简要总结
In recent years, with the further research of the pathogenesis of diabetes mellitus and the mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes drugs and insulin is getting paid more and more attention. A lot of studies have confirmed that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection. Based on these theory and practice, this study is designed to demonstrate whether the combination therapy of Gliclazide MR and basal insulin can control the blood glycemia effectively and reduce the dosage of insulin and the hypoglycemia events compared to the premix insulin monotherapy.
详细描述
Inclusion criteria:
- Male or female with type 2 diabetes mellitus
- 35 years old≤age≤65 years old
- 19kg/m2≤BMI≤32kg/m2
- Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months
- Treated by diet controlling, 1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent not more than 50% of its maximum
- Not participated in other clinical studies within the past 3 months
- Well know this study and sign the informed consent form
Exclusion criteria:
- Unable to sign the informed consent form
- Treated by insulin, even transient usage within the past 1 year
- Type 1 diabetes mellitus
- Abnormal condition of gastrointestinal tract against the absorption of oral drugs
- Insufficient of liver and kidney function: ALT≥2.5 times of the upper limit of the normal value range and serum creatinine≥the upper limit of the normal value range
- Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the past half year
- Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
- psychotic
- Allergic history to sulfonylurea drugs
- Diabetic coma or diabetic ketoacidosis
- In use of the miconazole
- Pregnancy or breeding women
Primary endpoint:
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combination therapy
The subjects allocated into this arm will receive the combination therapy of oral administration of 60~120mg Gliclazide MR (Diamicron MR) and subcutaneous injection of basal insulin (Insulin Glargine Injection, Lantus) once daily for 3 months
干预措施: Gliclazide MR and Insulin Glargine Injection (Drug)
monotherapy
The patients allocated into this arm will receive the monotherapy of subcutaneous injection of premixed insulin (Biosynthetic Human Insulin Injection, Novolin 30R) twice daily for 3 months.
干预措施: Biosynthetic Human Insulin Injection (Drug)
结局指标
主要结局
Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG
时间窗: 3 months
次要结局
- MBG, SDBG, MAGE and MODD in the 48th CGMS(3 months)
- Incidence of hypoglycemia and severe hypoglycemia(3 months)
- Weight change(3 months)