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

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

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 .

Study Overview

• Status: Completed
• Conditions: Diabete Mellitus
• Intervention / Treatment: Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg); Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Bahria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B received Empagliflozin with Linagliptin; Empagliflozin 10 mg, along with Tab Linagliptin 5mg.	Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg); (Empagliflozin 10 mg+ Tab Linagliptin 5mg)was given once Orally daily; Other Names: Diampa LT (10/5 ) MG; Xenglu- Lin (10 / 5 ) MG; Empaa L ( 10 / 5 ) MG
Active Comparator: Group A received Empagliflozin with Metformin; Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg	Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg; Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg; Other Names: Xenglu - Met XR ( 10 / 500 ) MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall improvement in Fasting Blood Glucose	Fasting Blood glucose ( mg / dl ) was measured using Glucometer	12 weeks
Overall change in Body Mass Index ( kg/m2)	Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .	12 weeks
Overall improvement in Random Blood Glucose	Random Blood Glucose was measured in mg/dl using Glucometer	12 weeks
Over all improvement in Glycated Hemoglobin ( HbA1c)	Blood sample was taken to assess HbA1c	12 weeks
Overall change in Waist to Hip Ratio	Measuring tape was used to measure	12 weeks
Overall change in Waist Circumference	Was measured in inches using measuring tape	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To observe adverse effects in treatment groups	To evaluate any incidence of Hypoglycemic events during study period; To evaluate any incidence of Glycosuria during study period	12 weeks

Collaborators and Investigators

• Sponsor: Bahria University
• Investigators: Principal Investigator: NABILA RAFI, doctor

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: BMI; Waist to Hip Ratio; HBA1C; liver profile; Renal Function tests
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purines; Biguanides; Guanidines; Amidines; Quinazolines; Linagliptin; Metformin; empagliflozin
• Other Study ID Numbers: ERC 105/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD data will be shared
• IPD Sharing Time Frame: 1 year after article publication
• IPD Sharing Access Criteria: Access to all
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No