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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07541456
Acronym
EMPA-BP
Enrollment
300
Registered
2026-04-21
Start date
2025-06-09
Completion date
2025-11-08
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Type 2 Diabetes Mellitus

Keywords

Empagliflozin, SGLT2 inhibitor, Metformin, Blood pressure

Brief 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. 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.

Interventions

DRUGEmpagliflozin

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

DRUGMetformin

Metformin 500 mg twice daily for 12 weeks.

Sponsors

Dr. Zarmina Younes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blood pressure outcomes were assessed by a ward doctor who was not aware of study group allocation.

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Systolic Blood PressureBaseline to 12 weeksChange in systolic blood pressure from baseline to 12 weeks after assigned treatment.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORZarmina Younes

Department of Internal Medicine, Shahida Islam Teaching Hospital, Lodhran, Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026