Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes (EMPA-BP)

April 16, 2026 updated by: Dr. Zarmina Younes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lodhran, Punjab Province, Pakistan
        • Shahida Islam Medical College, Lodhran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Heart failure Chronic renal failure Pregnant women History of hypertension preceding type 2 diabetes mellitus by more than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empagliflozin
Participants received empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12.
Drug: Empagliflozin
Empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12.
Active Comparator: Metformin
Participants received metformin 500 mg twice daily for 12 weeks.
Drug: Metformin
Metformin 500 mg twice daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline to 12 weeks
Change in systolic blood pressure from baseline to 12 weeks after assigned treatment.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Zarmina Younes

Investigators

  • Principal Investigator: Zarmina Younes, Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Actual)

November 8, 2025

Study Completion (Actual)

November 8, 2025

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMC-IM-EMPA-BP-RCT-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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