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Completed

NCT Number: NCT07247656

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

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 .

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bahria University

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(Empagliflozin 10 mg+ Tab Linagliptin 5mg)

Drug

(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

Tab Empagliflozin 10 mg + Tab Metformin 500 mg

Drug

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

Other names: Xenglu - Met XR ( 10 / 500 ) MG

Primary outcomes

  1. Overall improvement in Fasting Blood Glucose

    Time frame: 12 weeks

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

  2. 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 .

  3. Overall improvement in Random Blood Glucose

    Time frame: 12 weeks

    Random Blood Glucose was measured in mg/dl using Glucometer

  4. Over all improvement in Glycated Hemoglobin ( HbA1c)

    Time frame: 12 weeks

    Blood sample was taken to assess HbA1c

  5. Overall change in Waist to Hip Ratio

    Time frame: 12 weeks

    Measuring tape was used to measure

  6. Overall change in Waist Circumference

    Time frame: 12 weeks

    Was measured in inches using measuring tape

Secondary outcomes

  1. To observe adverse effects in treatment groups

    Time frame: 12 weeks

    • To evaluate any incidence of Hypoglycemic events during study period
    • To evaluate any incidence of Glycosuria during study period

Sponsors and collaborators

Lead sponsor

Bahria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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