Type 2 Diabetes MellitusPhase 4EMPA-BPNCT07541456
Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes
A Phase 4 study testing Empagliflozin and Metformin in people with Type 2 Diabetes Mellitus and Hypertension, run by Dr. Zarmina Younes at 1 site in Pakistan.
Trial summary
This randomized controlled trial studied whether empagliflozin lowers blood pressure better than non-SGLT2 oral hypoglycemic treatment in adults with type 2 diabetes mellitus and hypertension. A total of 300 participants were assigned to 1 of 2 treatment groups and followed for 12 weeks. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Empagliflozin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Jun 2025to 8 Nov 2025
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 70 years Either male or female Type 2 diabetes mellitus for more than 3 months Hypertension for more than 3 months
Who cannot join
- Heart failure Chronic renal failure Pregnant women History of hypertension preceding type 2 diabetes mellitus by more than 6 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shahida Islam Medical College, Lodhran
Lodhran, Punjab Province
About this study
Official title: Comparison of Mean Blood Pressure in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin Versus Non-SGLT2 Oral Hypoglycemic Agents: A Randomized Controlled Trial
This randomized controlled trial studied whether empagliflozin lowers blood pressure better than non-SGLT2 oral hypoglycemic treatment in adults with type 2 diabetes mellitus and hypertension. A total of 300 participants were assigned to 1 of 2 treatment groups and followed for 12 weeks. One group received empagliflozin and the other received non-SGLT2 oral therapy. Blood pressure was measured at baseline and again after 12 weeks to compare the effect of treatment on systolic and diastolic blood pressure.
Read the detailed description
This single-center randomized controlled trial was conducted in the Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan. Adults aged 20 to 70 years with type 2 diabetes mellitus and hypertension of more than 3 months duration were enrolled. Patients with heart failure, chronic renal failure, pregnancy, or a history of hypertension preceding type 2 diabetes mellitus by more than 6 months were excluded. A total of 300 participants were randomized into 2 parallel groups. Group A received empagliflozin 10 mg for the first 4 weeks, increased to 25 mg up to week 12. Group B received non-SGLT2 oral hypoglycemic therapy with metformin 500 mg twice daily. Blood pressure was recorded at baseline and after 12 weeks of treatment. The primary objective was to compare changes in systolic and diastolic blood pressure between the 2 groups after 12 weeks of treatment.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Empagliflozin, Metformin
- Keywords
- Empagliflozin, SGLT2 inhibitor, Metformin, Blood pressure
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12.
MetforminDrug
Metformin 500 mg twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Participants received empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12. Receives: Drug: Empagliflozin |
| Metformin | Active comparator | Participants received metformin 500 mg twice daily for 12 weeks. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline to 12 weeks after assigned treatment.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start9 Jun 2025
- Primary completion8 Nov 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Zarmina Younes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Zarmina Younes, Shahida Islam Medical Complex
- Investigators
- Zarmina Younes, Principal investigator, Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541456
- Sponsor's protocol ID
- SIMC-IM-EMPA-BP-RCT-2025-01
- Acronym
- EMPA-BP
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Blood Pressure in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin Versus Non-SGLT2 Oral Hypoglycemic Agents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07541456
- Acronym / sponsor ID
- EMPA-BP / SIMC-IM-EMPA-BP-RCT-2025-01
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- Empagliflozin, SGLT2 inhibitor, Metformin, Blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Dr. Zarmina YounesUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 21 Apr 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 randomized controlled trial studied whether empagliflozin lowers blood pressure better than non-SGLT2 oral hypoglycemic treatment in adults with type 2 diabetes mellitus and hypertension. A total of 300 participants were assigned to 1 of 2 treatment groups and followed for 12 weeks. One group received empagliflozin and the other received non-SGLT2 oral therapy. Blood pressure was measured at baseline and again after 12 weeks to compare the effect of treatment on systolic and diastolic blood pressure.
Detailed description
This single-center randomized controlled trial was conducted in the Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan. Adults aged 20 to 70 years with type 2 diabetes mellitus and hypertension of more than 3 months duration were enrolled. Patients with heart failure, chronic renal failure, pregnancy, or a history of hypertension preceding type 2 diabetes mellitus by more than 6 months were excluded. A total of 300 participants were randomized into 2 parallel groups. Group A received empagliflozin 10 mg for the first 4 weeks, increased to 25 mg up to week 12. Group B received non-SGLT2 oral hypoglycemic therapy with metformin 500 mg twice daily. Blood pressure was recorded at baseline and after 12 weeks of treatment. The primary objective was to compare changes in systolic and diastolic blood pressure between the 2 groups after 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinParticipants received empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12. |
| Metformin | Active comparator | Drug: MetforminParticipants received metformin 500 mg twice daily for 12 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 20 to 70 years Either male or female Type 2 diabetes mellitus for more than 3 months Hypertension for more than 3 months
Key exclusion criteria (1 listed)
- Heart failure Chronic renal failure Pregnant women History of hypertension preceding type 2 diabetes mellitus by more than 6 months
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 |
|---|---|---|
| EmpagliflozinEmpagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12. | Drug | Empagliflozin |
| MetforminMetformin 500 mg twice daily for 12 weeks. | Drug | Metformin |
Primary outcome
Change in Systolic Blood Pressure
Time frame: Baseline to 12 weeks
Change in systolic blood pressure from baseline to 12 weeks after assigned treatment.
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 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Zarmina Younes principal investigator
Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan
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 and Metformin in people with Type 2 Diabetes Mellitus and Hypertension, run by Dr. Zarmina Younes 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 1 inclusion and 1 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 21 Apr 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.
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?
Change in Systolic Blood Pressure (time frame: Baseline to 12 weeks). 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 21 Apr 2026.