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临床试验/NCT07247656
NCT07247656已完成4 期

Comparison of Empagliflozin- Linagliptin With Empagliflozin- Metformin Combination Therapy in Reduction of Body Weight in Type 2 Diabetes Mellitus

Bahria University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月1日最近更新:
干预措施

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

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Nabila Rafi

MBBS , M.PHIL PHARMACOLOGY

Bahria University

研究点 (1)

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