Effect of Oral Combination Therapy of Metformin Extended Release Over Glimepiride in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus With Failure of Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- fasting glucose, HbA1c
研究概览
简要总结
The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure.
详细描述
A randomized double-blind clinical trial, to determine the effect of combined therapy of oral prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c. Patients will be included in this study are patients with diabetes mellitus and secondary failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin secretion. We evaluate the clinical measurements, laboratory and safety during 3 months, through the allocation of subjects to three study groups (metformin, glimepiride and metformin extended release / glimepiride)
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 to 65 years old
- •Ability to communicate and to meet the requirements of the study
- •Signed Written Informed Consent before to conducting any study
- •Body Mass Index (BMI) = 25-40kg/m2
- •Stable weight in the past three months (variability <5%)
- •Meal plan and monotherapy with oral hypoglycaemic fails
- •Fasting glucose = 130-270 mg/dL
- •HbA1c > 7%
- •isocaloric diet with a minimum of 250 grams of carbohydrates per day in the three days prior to making the laboratory tests
排除标准
- •Suspected or confirmed pregnancy
- •Inability to secure the non-pregnant during the study duration
- •Hypersensitivity to any of the drugs under study
- •Treatment with oral hypoglycemic or insulin
- •Consumption of substance with toxic effects on any organ system
- •Liver failure, heart failure, kidney failure or thyroid disease
- •Chronic intake of alcohol
- •Periods of acute or chronic diarrhea or vomiting
- •Consumption of antifungal azoles, MAO inhibitors, nifedipine,furosemide, amiloride, digoxin, procainamide, quinidine, quinine, triamterene and vancomycin
研究组 & 干预措施
combination
long acting Metformin/Glimepiride
干预措施: metformin/glimepiride combination (Drug)
metformin
metformin hydrocloride
干预措施: metformin (Drug)
glimepiride
glimepiride
干预措施: glimepiride (Drug)
结局指标
主要结局
fasting glucose, HbA1c
时间窗: three months
次要结局
- total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin(three months)