Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study

Launched by GETZ PHARMA · Dec 7, 2021

Keywords

ClinConnect Summary

The EASE Study is a clinical trial designed to evaluate the safety and effectiveness of a medication called Empagliflozin, which is used to manage Type II Diabetes Mellitus, either on its own or combined with another medication called Metformin. This study is particularly focused on patients in Pakistan and aims to gather real-world data about how these medications work for people with diabetes. If you are between the ages of 18 and 65, have a specific level of blood sugar control (an HbA1C between 7% and 10%), and have not had success with other diabetes treatments, you may be eligible to participate.

As a participant, you will be monitored for any side effects over a period of 12 months, with follow-up visits at 4 to 6 weeks, 12 weeks, and 24 weeks after starting the medication. During these visits, you will undergo various laboratory tests to check your blood sugar levels and kidney function, and you will receive discounts on these tests. This study aims to ensure that Empagliflozin is safe and tolerable for patients like you, helping to improve diabetes care in your community.

Gender

ALL

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.