Diabete MellitusPhase 4NCT07247656
The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic Patients .
A Phase 4 study testing (Empagliflozin 10 mg+ Tab Linagliptin 5mg) and Tab Empagliflozin 10 mg + Tab Metformin 500 mg in people with Diabete Mellitus, run by Bahria University at 1 site in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- (Empagliflozin 10 mg+ Tab Linagliptin 5mg) and Tab Empagliflozin 10 mg + Tab Metformin 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2022to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Empagliflozin- Linagliptin With Empagliflozin- Metformin Combination Therapy in Reduction of Body Weight in Type 2 Diabetes Mellitus
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.
- Conditions
- Diabete Mellitus
- Being tested
- (Empagliflozin 10 mg+ Tab Linagliptin 5mg), Tab Empagliflozin 10 mg + Tab Metformin 500 mg
- Keywords
- liver profile, BMI, Waist to Hip Ratio, Renal Function tests, HBA1C
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Empagliflozin 10 mg+ Tab Linagliptin 5mg)Drug
Also called 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 mgDrug
Also called Xenglu - Met XR ( 10 / 500 ) MG
Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Group B received Empagliflozin with Linagliptin | Active comparator | Empagliflozin 10 mg, along with Tab Linagliptin 5mg. Receives: 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 Receives: Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall improvement in Fasting Blood Glucose
Fasting Blood glucose ( mg / dl ) was measured using Glucometer
Measured: 12 weeks
Overall change in Body Mass Index ( kg/m2)
Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .
Measured: 12 weeks
Overall improvement in Random Blood Glucose
Random Blood Glucose was measured in mg/dl using Glucometer
Measured: 12 weeks
Over all improvement in Glycated Hemoglobin ( HbA1c)
Blood sample was taken to assess HbA1c
Measured: 12 weeks
Overall change in Waist to Hip Ratio
Measuring tape was used to measure
Measured: 12 weeks
Overall change in Waist Circumference
Was measured in inches using measuring tape
Measured: 12 weeks
Secondary outcomes (1)
To observe adverse effects in treatment groups
- To evaluate any incidence of Hypoglycemic events during study period
- To evaluate any incidence of Glycosuria during study period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2022
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nabila Rafi, Bahria University
- Investigators
- NABILA RAFI, Principal investigator, DOCTOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247656
- Sponsor's protocol ID
- ERC 105/2022
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Empagliflozin- Linagliptin With Empagliflozin- Metformin Combination Therapy in Reduction of Body Weight in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07247656
- Acronym / sponsor ID
- ERC 105/2022
- Conditions
- Diabete Mellitus
- Keywords
- liver profile, BMI, Waist to Hip Ratio, Renal Function tests, HBA1C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 mgTab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Diabetic men and women of age 40-70 yrs.
Key exclusion criteria (7 listed)
- Male and female type 1 diabetic patients with BMI <25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Empagliflozin 10 mg+ Tab Linagliptin 5mg)Also: 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 | Drug | Group B received Empagliflozin with Linagliptin |
| Tab Empagliflozin 10 mg + Tab Metformin 500 mgAlso: Xenglu - Met XR ( 10 / 500 ) MGTab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg | Drug | Group A received Empagliflozin with Metformin |
Primary outcome
Overall improvement in Fasting Blood Glucose
Time frame: 12 weeks
Fasting Blood glucose ( mg / dl ) was measured using Glucometer
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 .
Overall improvement in Random Blood Glucose
Time frame: 12 weeks
Random Blood Glucose was measured in mg/dl using Glucometer
Over all improvement in Glycated Hemoglobin ( HbA1c)
Time frame: 12 weeks
Blood sample was taken to assess HbA1c
Overall change in Waist to Hip Ratio
Time frame: 12 weeks
Measuring tape was used to measure
Overall change in Waist Circumference
Time frame: 12 weeks
Was measured in inches using measuring tape
1 secondary outcome
To observe adverse effects in treatment groups
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. All collected IPD data will be shared
Related trials for Diabete Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NABILA RAFI principal investigator
DOCTOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing (Empagliflozin 10 mg+ Tab Linagliptin 5mg) and Tab Empagliflozin 10 mg + Tab Metformin 500 mg in people with Diabete Mellitus, run by Bahria University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall improvement in Fasting Blood Glucose (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.