The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic Patients .

Bahria University200 enrolled

Overview

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 .

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Diabete Mellitus

Interventions

(Empagliflozin 10 mg+ Tab Linagliptin 5mg)DRUG

(Empagliflozin 10 mg+ Tab Linagliptin 5mg)was given once Orally daily

Tab Empagliflozin 10 mg + Tab Metformin 500 mgDRUG

Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 - * CLD * Cancer patient

Locations (1)

Bahria University

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Overall improvement in Fasting Blood Glucose

Fasting Blood glucose ( mg / dl ) was measured using Glucometer

Time frame: 12 weeks

Overall change in Body Mass Index ( kg/m2)

Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .

Time frame: 12 weeks

Overall improvement in Random Blood Glucose

Random Blood Glucose was measured in mg/dl using Glucometer

Time frame: 12 weeks

Over all improvement in Glycated Hemoglobin ( HbA1c)

Blood sample was taken to assess HbA1c

Time frame: 12 weeks

Overall change in Waist to Hip Ratio

Measuring tape was used to measure

Time frame: 12 weeks

Overall change in Waist Circumference

Was measured in inches using measuring tape

Time frame: 12 weeks

Secondary Outcomes

To observe adverse effects in treatment groups

1. To evaluate any incidence of Hypoglycemic events during study period 2. To evaluate any incidence of Glycosuria during study period

Time frame: 12 weeks

Data from ClinicalTrials.gov

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