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CompletedNCT07247656Updated Nov 25, 2025

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

A Phase 4 interventional study of (Empagliflozin 10 mg+ Tab Linagliptin 5mg) and Tab Empagliflozin 10 mg + Tab Metformin 500 mg in Diabete Mellitus, sponsored by Bahria University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Bahria University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Dec 2022, registered Sep 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Diabete Mellitus

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Keywords

  • liver profile
  • BMI
  • Waist to Hip Ratio
  • Renal Function tests
  • HBA1C
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Bahria University is the lead sponsor of 35 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Group B received Empagliflozin with Linagliptin

    Empagliflozin 10 mg, along with Tab Linagliptin 5mg.

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

  • 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

Interventions

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

    (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

  • DrugTab Empagliflozin 10 mg + Tab Metformin 500 mg

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

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

06

What researchers measure

Primary outcomes

  1. Overall improvement in Fasting Blood Glucose

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

    Time frame: 12 weeks

  2. Overall change in Body Mass Index ( kg/m2)

    Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .

    Time frame: 12 weeks

  3. Overall improvement in Random Blood Glucose

    Random Blood Glucose was measured in mg/dl using Glucometer

    Time frame: 12 weeks

  4. Over all improvement in Glycated Hemoglobin ( HbA1c)

    Blood sample was taken to assess HbA1c

    Time frame: 12 weeks

  5. Overall change in Waist to Hip Ratio

    Measuring tape was used to measure

    Time frame: 12 weeks

  6. Overall change in Waist Circumference

    Was measured in inches using measuring tape

    Time frame: 12 weeks

Secondary outcomes

  1. To observe adverse effects in treatment groups

    1. To evaluate any incidence of Hypoglycemic events during study period 2. To evaluate any incidence of Glycosuria during study period

    Time frame: 12 weeks

07

Study locations

1 site
  • Bahria University
    Karachi, Sindh, Pakistan
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD data will be shared

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07247656
Lead sponsor
Bahria University
Responsible party
Dr. Nabila Rafi (MBBS , M.PHIL PHARMACOLOGY, Bahria University) — Principal investigator
First posted
Nov 25, 2025
Start date
Dec 1, 2022
Primary completion
Mar 1, 2023
Completion
May 1, 2023
Last update
Nov 25, 2025

Study contacts

NABILA RAFI
principal investigator · DOCTOR

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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