Diabetic NephropathiesNCT07866235
Comparing The Effect Of Empagliflozin With Dapagliflozin In Reducing Proteinuria In Diabetic Patients With Chronic Kidney Disease With eGFR More Than 45ml/Min/1.73m²
A study testing Dapagliflozin and Empagliflozin (EMPA) in people with Diabetic Nephropathies and Diabetes Mellitus, Type 2, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
This study was designed to compare empagliflozin and dapagliflozin in reducing protein leakage into the urine in adults with type 2 diabetes and chronic kidney disease. It examined whether the two medicines differed in their effects on urine protein levels. Read more about this study
- Who is it for?
- Ages 20 months to 70 years
- Conditions the study is for
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
- What is being tested?
- Dapagliflozin and Empagliflozin (EMPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Oct 2023to 10 Apr 2024
- Phase
- Interventional
- 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 20 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 20-70 years.
- Male or female patients.
- Type 2 diabetes mellitus with chronic kidney disease.
- Body mass index ≤45.0 kg/m².
- Urinary albumin-to-creatinine ratio >30 mg/g.
- Estimated glomerular filtration rate >45 mL/min/1.73 m².
- Stable dose of an oral antidiabetic medication for at least 4 weeks, or insulin, either alone or with an oral antidiabetic medication, for 8 weeks.
- Stable dose of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker for at least 4 weeks.
Who cannot join
- Type 1 diabetes mellitus.
- Age below 20 years or above 70 years.
- Pregnancy.
- Hypersensitivity to the study medications.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
This study was designed to compare empagliflozin and dapagliflozin in reducing protein leakage into the urine in adults with type 2 diabetes and chronic kidney disease. It examined whether the two medicines differed in their effects on urine protein levels. Blood sugar control, kidney function, treatment costs, and side effects were also selected for comparison.
The study was planned as a randomized controlled trial at the Nephrology Department of Lahore General Hospital, Lahore, Pakistan. The planned sample comprised 116 men and women aged 20-70 years who had increased urine albumin levels and an estimated glomerular filtration rate, a measure of kidney filtration, above 45 mL/min/1.73 m². Participants were to be assigned by a lottery method to two equal groups of 58 patients. One group was to receive dapagliflozin 5 mg once daily, and the other empagliflozin 10 mg once daily.
Assessments were scheduled before treatment and after two and four months. The main assessment was the change in the urine albumin-to-creatinine ratio, which measured the amount of albumin, a blood protein, leaking into the urine. Other assessments included blood tests for kidney function and average blood sugar levels. Treatment costs and side effects, including low blood sugar, urinary tract infections, oral thrush, dehydration, allergic reactions, body pains, and kidney failure, were also included in the follow-up plan. The study aimed to compare the benefits, safety, and costs of these treatments in the selected patients.
- Being tested
- Dapagliflozin, Empagliflozin (EMPA)
- Keywords
- Empagliflozin, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Diabetic Kidney Disease, Albuminuria
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin tablet, 5 mg orally once daily for four months.
Empagliflozin (EMPA)Drug
Empagliflozin tablet, 10 mg orally once daily for four months.
| Study group | Role | What they receive |
|---|---|---|
| Group A-Dapagliflozin | Active comparator | Patients were assigned to dapagliflozin 5 mg orally once daily for four months, alongside their existing treatment for diabetes and hypertension. Receives: Drug: Dapagliflozin |
| Group B-Empagliflozin | Experimental | Patients were assigned to empagliflozin 10 mg orally once daily for four months, alongside their existing treatment for diabetes and hypertension. Receives: Drug: Empagliflozin (EMPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary albumin-to-creatinine ratio
Change from baseline in urinary albumin-to-creatinine ratio, measured in mg/g using a spot urine sample. Changes were compared between the dapagliflozin and empagliflozin groups to assess reduction in albuminuria.
Measured: Baseline, 2 months, and 4 months
Change in glycated haemoglobin
Change from baseline in glycated haemoglobin, measured as a percentage, was compared between the treatment groups to assess glycaemic control.
Measured: Baseline, 2 months, and 4 months
Change in estimated glomerular filtration rate
Change from baseline in estimated glomerular filtration rate, expressed in mL/min/1.73 m² and calculated using the Modification of Diet in Renal Disease equation, was compared between the treatment groups.
Measured: Baseline, 2 months, and 4 months
Treatment cost per participant
Treatment expenditure per participant, expressed in Pakistani rupees, was recorded over the four-month treatment period and compared between the treatment groups.
Measured: From treatment initiation through 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start11 Oct 2023
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Muneeb Afsar, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866235
- Sponsor's protocol ID
- LahoreGeneralH21
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effect Of Empagliflozin With Dapagliflozin In Reducing Proteinuria In Diabetic Patients With Chronic Kidney Disease With eGFR More Than 45ml/Min/1.73m²
- ClinicalTrials.gov ID
- NCT07866235
- Acronym / sponsor ID
- LahoreGeneralH21
- Keywords
- Empagliflozin, Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Diabetic Kidney Disease, Albuminuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 8 Oct 2026 (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.
This study was designed to compare empagliflozin and dapagliflozin in reducing protein leakage into the urine in adults with type 2 diabetes and chronic kidney disease. It examined whether the two medicines differed in their effects on urine protein levels. Blood sugar control, kidney function, treatment costs, and side effects were also selected for comparison.
The study was planned as a randomized controlled trial at the Nephrology Department of Lahore General Hospital, Lahore, Pakistan. The planned sample comprised 116 men and women aged 20-70 years who had increased urine albumin levels and an estimated glomerular filtration rate, a measure of kidney filtration, above 45 mL/min/1.73 m². Participants were to be assigned by a lottery method to two equal groups of 58 patients. One group was to receive dapagliflozin 5 mg once daily, and the other empagliflozin 10 mg once daily.
Assessments were scheduled before treatment and after two and four months. The main assessment was the change in the urine albumin-to-creatinine ratio, which measured the amount of albumin, a blood protein, leaking into the urine. Other assessments included blood tests for kidney function and average blood sugar levels. Treatment costs and side effects, including low blood sugar, urinary tract infections, oral thrush, dehydration, allergic reactions, body pains, and kidney failure, were also included in the follow-up plan. The study aimed to compare the benefits, safety, and costs of these treatments in the selected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Dapagliflozin | Active comparator | Drug: DapagliflozinPatients were assigned to dapagliflozin 5 mg orally once daily for four months, alongside their existing treatment for diabetes and hypertension. |
| Group B-Empagliflozin | Experimental | Drug: Empagliflozin (EMPA)Patients were assigned to empagliflozin 10 mg orally once daily for four months, alongside their existing treatment for diabetes and hypertension. |
Who may qualify
- Ages
- 20 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 20-70 years.
- Male or female patients.
- Type 2 diabetes mellitus with chronic kidney disease.
- Body mass index ≤45.0 kg/m².
- Urinary albumin-to-creatinine ratio >30 mg/g.
Key exclusion criteria (4 listed)
- Type 1 diabetes mellitus.
- Age below 20 years or above 70 years.
- Pregnancy.
- Hypersensitivity to the study medications.
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 |
|---|---|---|
| DapagliflozinDapagliflozin tablet, 5 mg orally once daily for four months. | Drug | Group A-Dapagliflozin |
| Empagliflozin (EMPA)Empagliflozin tablet, 10 mg orally once daily for four months. | Drug | Group B-Empagliflozin |
Primary outcome
Change in urinary albumin-to-creatinine ratio
Time frame: Baseline, 2 months, and 4 months
Change from baseline in urinary albumin-to-creatinine ratio, measured in mg/g using a spot urine sample. Changes were compared between the dapagliflozin and empagliflozin groups to assess reduction in albuminuria.
Change in glycated haemoglobin
Time frame: Baseline, 2 months, and 4 months
Change from baseline in glycated haemoglobin, measured as a percentage, was compared between the treatment groups to assess glycaemic control.
Change in estimated glomerular filtration rate
Time frame: Baseline, 2 months, and 4 months
Change from baseline in estimated glomerular filtration rate, expressed in mL/min/1.73 m² and calculated using the Modification of Diet in Renal Disease equation, was compared between the treatment groups.
Treatment cost per participant
Time frame: From treatment initiation through 4 months
Treatment expenditure per participant, expressed in Pakistani rupees, was recorded over the four-month treatment period and compared between the treatment groups.
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 8 Oct 2026.
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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.
Muneeb Afsar principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin and Empagliflozin (EMPA) in people with Diabetic Nephropathies and Diabetes Mellitus, Type 2, run by Lahore General Hospital 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 8 inclusion and 4 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 8 Oct 2026. 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.
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?
Change in urinary albumin-to-creatinine ratio (time frame: Baseline, 2 months, and 4 months). The study lists 4 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 8 Oct 2026.