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Completed

NCT Number: NCT07541456

Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shahida Islam Medical College, Lodhran

Lodhran, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

Empagliflozin 10 mg once daily for the first 4 weeks, increased to 25 mg once daily until week 12.

metformin

Drug

Metformin 500 mg twice daily for 12 weeks.

Primary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Baseline to 12 weeks

    Change in systolic blood pressure from baseline to 12 weeks after assigned treatment.

Sponsors and collaborators

Lead sponsor

Dr. Zarmina Younes

Other

Registry information

Official study 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

Acronym: EMPA-BP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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