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

NCT ID: NCT07247656

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-05-01

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Diabete Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group B received Empagliflozin with Linagliptin

Empagliflozin 10 mg, along with Tab Linagliptin 5mg.

Group Type ACTIVE_COMPARATOR

(Empagliflozin 10 mg+ Tab Linagliptin 5mg)

Intervention Type DRUG

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

Group A received Empagliflozin with Metformin

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

Group Type ACTIVE_COMPARATOR

Tab Empagliflozin 10 mg + Tab Metformin 500 mg

Intervention Type DRUG

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

Interventions

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(Empagliflozin 10 mg+ Tab Linagliptin 5mg)

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

Intervention Type DRUG

Tab Empagliflozin 10 mg + Tab Metformin 500 mg

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

Intervention Type DRUG

Other Intervention Names

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Diampa LT (10/5 ) MG Xenglu- Lin (10 / 5 ) MG Empaa L ( 10 / 5 ) MG Xenglu - Met XR ( 10 / 500 ) MG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bahria University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nabila Rafi

MBBS , M.PHIL PHARMACOLOGY

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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NABILA RAFI

Role: PRINCIPAL_INVESTIGATOR

DOCTOR

Locations

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Bahria University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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ERC 105/2022

Identifier Type: -

Identifier Source: org_study_id

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