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

NCT07541456 | Completed Phase 4

• 1 other identifier: SIMC-IM-EMPA-BP-RCT-2025-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Hypertension

Keywords

Empagliflozin; SGLT2 inhibitor; Metformin; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure

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

  Baseline to 12 weeks

Study Arms (2)

Empagliflozin

EXPERIMENTAL

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

Drug: Empagliflozin

Metformin

ACTIVE COMPARATOR

Participants received metformin 500 mg twice daily for 12 weeks.

Drug: Metformin

Interventions

Empagliflozin DRUG

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

Empagliflozin

Metformin DRUG

Metformin 500 mg twice daily for 12 weeks.

Metformin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Zarmina Younes: lead

Study Sites (1)

Shahida Islam Medical College, Lodhran

Lodhran, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

empagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Zarmina Younes

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blood pressure outcomes were assessed by a ward doctor who was not aware of study group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 21, 2026
• Study Start: June 9, 2025
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)