Empagliflozin with or without metformin for safety and tolerability in adults with Type 2 diabetes

Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus

This project will try empagliflozin, with or without metformin, in adults with Type 2 diabetes to see if it is safe and well tolerated in routine clinical care at participating centers.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Getz Pharma (Industry-sponsored)
• Locations: 6 sites (Kabul, Afghanistan and 5 other locations)
• Trial ID: NCT05164263 on ClinicalTrials.gov

What this trial studies

This is an open-label, prospective, observational, single-arm, multi-center post-marketing surveillance study enrolling about 156 adults with Type 2 diabetes. Participants who are empagliflozin-naive and meet entry criteria (age 18–65, HbA1c 7–10%, eGFR >60 mL/min/1.73 m2, uncontrolled on oral therapy and lifestyle measures) will start empagliflozin with or without metformin and be followed for safety over three scheduled visits at ~4–6 weeks, 12 weeks, and 24 weeks. The study focuses on monitoring adverse events including hypoglycemia, dehydration, hypotension, urinary and fungal infections, gastrointestinal symptoms, and other side effects. Data collection is intended to reflect real-world routine care in the participating clinical sites.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with Type 2 diabetes, HbA1c 7–10%, empagliflozin-naive, eGFR >60 mL/min/1.73 m2, and uncontrolled on oral antidiabetics plus lifestyle measures for at least 3 months who can provide informed consent.

Not a fit: Patients with type 1 diabetes, recurrent UTIs or fungal infections, significant renal or hepatic dysfunction, DKA or hyperosmolar states, severe hypoglycemia history, pregnancy or breastfeeding, pancreatitis, or known hypersensitivity are excluded and may not benefit from participation.

Why it matters

Potential benefit: If results show good tolerability and manageable side effects, patients could gain confidence that empagliflozin (with or without metformin) is a safe option in routine care for similar populations.

How similar studies have performed: SGLT2 inhibitors such as empagliflozin have extensive prior evidence for glycemic control and cardiovascular/renal benefits and a well-documented safety profile, so this study is a local post-marketing check of tolerability in routine practice.

Eligibility criteria

Inclusion Criteria:

Patient with T2DM between 18 to 65 years with HbA1C 7% - 10%, who can give informed consent. Patient uncontrolled on oral antidiabetics and lifestyle modification for at least 3 months. Patient who are empagliflozin naive. eGFR ˃60 mL/min/1.73m2.

Exclusion Criteria:

Type 1 diabetes, History of recurrent urinary tract infection (UTI), fungal infection, renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal, Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state, severe hypoglycemia, Pregnant or lactating women, Pancreatitis, any serious complications or hypersensitivity.

Where this trial is running

Kabul, Afghanistan and 5 other locations

• Kabul University of Medical Sciences(KUMS) — Kabul, Afghanistan, Afghanistan (Completed)
• Agha Khan univeristy hospital — Nairobi, Kenya, Kenya (Recruiting)
• Lagos University Teaching Hospital — Lagos, Nigeria, Nigeria (Recruiting)
• Umar Diabetes Foundation — Islamabad, Pakistan (Completed)
• National hospital Sri Lanka — Colombo, Colombo, Sri Lanka (Completed)
• Nhk — Kandy, Kandy, Sri Lanka (Completed)

Study contacts

• Principal investigator: Umar Wahab — Umar Diabetes Foundation
• Study coordinator: Dr. Muhammad Nabeed Tahir

Conditions Type II Diabetes Mellitus; Efficacy, Self; Safety Issues