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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Agha Khan univeristy hospital
  Nairobi, Kenya, Kenya Recruiting
• Lagos University Teaching Hospital
  Lagos, Nigeria, Nigeria Recruiting
• Kabul University of Medical Sciences(KUMS)
  Kabul, Afghanistan, Afghanistan Completed
• 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
• Email: nabeedt@gmail.com
• Phone: +923015376299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.