Safety and Effectiveness of Empagliflozin With or Without Metformin in Adults Aged 18 to 65 with Type II Diabetes

What this Trial Is About

Researchers are evaluating the safety and tolerability of Empagliflozin, with or without metformin, in patients with Type II Diabetes Mellitus within the Pakistani population. This open-label, prospective, observational, single-arm, multi-center post-marketing surveillance study aims to monitor side effects such as hypoglycemia, dehydration, urinary tract infections, and gastrointestinal symptoms. The study is sponsored by Getz Pharma and includes adults aged 18 to 65 years with uncontrolled diabetes despite oral antidiabetic treatment and lifestyle modifications. Participants will receive Empagliflozin alone or combined with metformin in varying doses. The study includes three follow-up visits after starting therapy the first at 4 to 6 weeks, the second at 12 weeks, and the third at 24 weeks. Laboratory tests such as HbA1c, fasting blood glucose, renal function tests, and urine routine examination will be conducted at reputable clinical labs, with participants receiving discounts for these tests. During the study, participants will be closely monitored for safety and efficacy outcomes over six months from enrollment. Assessments include clinical evaluations and laboratory investigations to track diabetes control and potential side effects. The total study duration is 12 months, with the primary outcomes focusing on safety and tolerability at six months and secondary outcomes on efficacy. Participants health will be carefully observed throughout the follow-up period.

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