Comparison of Empagliflozin- Linagliptin With Empagliflozin- Metformin Combination Therapy in Reduction of Body Weight in Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bahria University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Overall improvement in Random Blood Glucose
Study Overview
Brief Summary
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 .
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• 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
Exclusion Criteria
- •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
Arms & Interventions
Group B received Empagliflozin with Linagliptin
Empagliflozin 10 mg, along with Tab Linagliptin 5mg.
Intervention: (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
Intervention: Tab Empagliflozin 10 mg + Tab Metformin 500 mg (Drug)
Outcomes
Primary Outcomes
Overall improvement in Random Blood Glucose
Time Frame: 12 weeks
Random Blood Glucose was measured in mg/dl using Glucometer
Over all improvement in Glycated Hemoglobin ( HbA1c)
Time Frame: 12 weeks
Blood sample was taken to assess HbA1c
Overall change in Waist Circumference
Time Frame: 12 weeks
Was measured in inches using measuring tape
Overall improvement in Fasting Blood Glucose
Time Frame: 12 weeks
Fasting Blood glucose ( mg / dl ) was measured using Glucometer
Overall change in Body Mass Index ( kg/m2)
Time Frame: 12 weeks
Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .
Overall change in Waist to Hip Ratio
Time Frame: 12 weeks
Measuring tape was used to measure
Secondary Outcomes
- To observe adverse effects in treatment groups(12 weeks)
Investigators
Dr. Nabila Rafi
MBBS , M.PHIL PHARMACOLOGY
Bahria University