Comparison of Empagliflozin- Linagliptin With Empagliflozin- Metformin Combination Therapy in Reduction of Body Weight in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall improvement in Random Blood Glucose
研究概览
简要总结
The goal of this clinical trial is - Comparison of Empagliflozin - Linagliptin with Empagliflozin - Metformin combination therapy in reduction of body weight in T2DM Patients and it included 200 diabetic subjects with total study period of 12 weeks and individual study period of 4 weeks .
详细描述
The goal of this clinical trial is to evaluate the safety and efficacy of both the drugs combination in evaluating weight loss and glycemic parameters .
SPSS version 25 will be used to generate the descriptive statistics. Frequency and percentage figures will be used to represent the qualitative factors.
The comparison will be done between male of group A with male of group B and female of group A with female of group B.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Diabetic men and women of age 40-70 yrs.
- •HBA1C -(6.5-9 )percent
- •All diabetic patients were BMI ≥25kg/m2
- •Patient took metformin ≥1000mg/day for ≥ 3 months with uncontrolled DM
排除标准
- •Male and female type 1 diabetic patients with BMI <25
- •Diabetic patient taking oral medicine other than metformin for last 12 weeks
- •Subjects with creatinine >1.5mg/dl
- •Pregnant or Lactating Women
- •Co-morbidities -
- •Cancer patient
研究组 & 干预措施
Group B received Empagliflozin with Linagliptin
Empagliflozin 10 mg, along with Tab Linagliptin 5mg.
干预措施: (Empagliflozin 10 mg+ Tab Linagliptin 5mg) (Drug)
Group A received Empagliflozin with Metformin
Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg
干预措施: Tab Empagliflozin 10 mg + Tab Metformin 500 mg (Drug)
结局指标
主要结局
Overall improvement in Random Blood Glucose
时间窗: 12 weeks
Random Blood Glucose was measured in mg/dl using Glucometer
Over all improvement in Glycated Hemoglobin ( HbA1c)
时间窗: 12 weeks
Blood sample was taken to assess HbA1c
Overall change in Waist Circumference
时间窗: 12 weeks
Was measured in inches using measuring tape
Overall improvement in Fasting Blood Glucose
时间窗: 12 weeks
Fasting Blood glucose ( mg / dl ) was measured using Glucometer
Overall change in Body Mass Index ( kg/m2)
时间窗: 12 weeks
Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .
Overall change in Waist to Hip Ratio
时间窗: 12 weeks
Measuring tape was used to measure
次要结局
- To observe adverse effects in treatment groups(12 weeks)
研究者
Dr. Nabila Rafi
MBBS , M.PHIL PHARMACOLOGY
Bahria University