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

NCT07247656 — Phase 4, Completed, 200 participants, Bahria University

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

Registry	NCT07247656
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	200 (Actual)
Sponsor	Bahria University (Other)
Conditions	Diabete Mellitus
Interventions	(Empagliflozin 10 mg+ Tab Linagliptin 5mg), Tab Empagliflozin 10 mg + Tab Metformin 500 mg (Drug)
Dates	start 2022-12-01, primary completion 2023-03-01, completion 2023-05-01, first posted 2025-11-25, last updated 2025-11-25
Locations	1 site in Pakistan

-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 .

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group B received Empagliflozin with Linagliptin	Active comparator	Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg)	Empagliflozin 10 mg, along with Tab Linagliptin 5mg.
Group A received Empagliflozin with Metformin	Active comparator	Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg	Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg

(Empagliflozin 10 mg+ Tab Linagliptin 5mg) (Drug), also known as Diampa LT (10/5 ) MG, Xenglu- Lin (10 / 5 ) MG, Empaa L ( 10 / 5 ) MG: (Empagliflozin 10 mg+ Tab Linagliptin 5mg)was given once Orally daily
Tab Empagliflozin 10 mg + Tab Metformin 500 mg (Drug), also known as Xenglu - Met XR ( 10 / 500 ) MG: Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg

+Outcome measures

Primary outcomes

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

Secondary outcomes

To observe adverse effects in treatment groups [12 weeks]: 1. To evaluate any incidence of Hypoglycemic events during study period 2. To evaluate any incidence of Glycosuria during study period

+Eligibility

Sex: All, ages: 40 Years to 70 Years

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)

Facility	City	Country	Status
Bahria University	Karachi, Sindh	Pakistan

+Investigators

NABILA RAFI, Principal investigator, DOCTOR