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

NCT07247656 | Completed Phase 4 DMC

• 1 other identifier: ERC 105/2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 .

Conditions

Diabete Mellitus

Keywords

liver profile; BMI; Waist to Hip Ratio; Renal Function tests; HBA1C

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• To observe adverse effects in treatment groups

  12 weeks

Study Arms (2)

Group B received Empagliflozin with Linagliptin

ACTIVE COMPARATOR

Empagliflozin 10 mg, along with Tab Linagliptin 5mg.

Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg)

Group A received Empagliflozin with Metformin

ACTIVE COMPARATOR

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

Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg

Interventions

(Empagliflozin 10 mg+ Tab Linagliptin 5mg) DRUG

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

Also known as: Diampa LT (10/5 ) MG, Xenglu- Lin (10 / 5 ) MG, Empaa L ( 10 / 5 ) MG

Group B received Empagliflozin with Linagliptin

Tab Empagliflozin 10 mg + Tab Metformin 500 mg DRUG

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

Also known as: Xenglu - Met XR ( 10 / 500 ) MG

Group A received Empagliflozin with Metformin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Bahria University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin; Linagliptin; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• NABILA RAFI

  DOCTOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS , M.PHIL PHARMACOLOGY

Model Details: The patients was be divided two groups on the basis of their treatment option; group A Empagliflozin with Linagliptin group B Empagliflozin with Metformin The study was be ethically approved by the Bahria University ethical review committee (BUMDC). Informed consent was taken before initiating the clinical trial in male and female diabetic patients.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after article publication
• Access Criteria: Access to all

Locations

PA (1)