Efficacy/Safety Study of Adding Glimepiride to Type 2 Diabetes Patients With Inadequate Glycemic Control Based on Combination With Metformin And Basal Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 24 weeks after treatment, HbA1c values' change compared with baseline
研究概览
简要总结
All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and evidence is sufficient.At the same time the basal insulin injection once a day are more and more widely used in diabetes patients in China.
This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes patients with inadequate glycemic control with combined therapy of metformin and basal insulin.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the whole test process, voluntary and signed informed consent form
- •Men and women aged 35 to 70 years old
- •20≤BMI<35 Kg/m2
- •Diagnosed with type 2 diabetes
- •Undergoing metformin(Dose not less than 1000 mg/day)in combination with basal insulin injection once a day
- •HbA1c7.0-11%
- •Patients should be able to self blood glucose monitoring
排除标准
- •sulfonylureas,glinides,TZDs use within 3 months before the study
- •Pregnant or lactating women
- •A history of ketoacidosis
- •Allergy to sulfonylureas or sulfa drug patients
- •Apparent dysfunction of liver and kidney patients(ALT>2 times upper normal limit,serum creatinine>1.2 times upper normal limit)
- •Poor blood pressure control(systolic pressure>180mmHg or diastolic blood pressure>110mmHg)
- •heart disease,cardiac insufficiency,unstable angina pectoris,ECG indicates left ventricle hypertrophy,severe anemia(Hb<9.0g/d1)
- •Severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder)
- •BMI<20 orBMI≥35kg/m2
- •Alcohol or drug abuse ,or can't collaborate due to mental disorder
- •Digestion and absorption function obstacle or Other endocrine disorders
- •Other chronic diseases required long-term glucocorticoid treatment
研究组 & 干预措施
glimepiride
on the basis of metformin and glargine, the initial dose of glimepiride is 2 mg,qd (before breakfast), and adjust the dosage for fasting plasma glucose, dosage-adding indicator is the FPG≥7.2, maximum dose of glimepiride is 4 mg/d per day.
干预措施: glimepiride (Drug)
glimepiride
on the basis of metformin and glargine, the initial dose of glimepiride is 2 mg,qd (before breakfast), and adjust the dosage for fasting plasma glucose, dosage-adding indicator is the FPG≥7.2, maximum dose of glimepiride is 4 mg/d per day.
干预措施: glargine and metformin (Drug)
Metformin and glargine
on the basis of Metformin and glargine,no glempiride addition. dose of glargine was adjust according to the FPG, with the target less than 7.2mmol/l
干预措施: glargine and metformin (Drug)
结局指标
主要结局
24 weeks after treatment, HbA1c values' change compared with baseline
时间窗: 24 weeks after treatment
次要结局
- hypoglycemia events(24 weeks)
研究者
Qifu Li
Qifu Li, Chongqing Medical University
Chongqing Medical University