Real-world safety and effectiveness of empagliflozin (Diampa®) alone or in combination with metformin (Diampa-M®) in patients with type 2 diabetes mellitus in Pakistan: a multicenter observational study

Abstract

Abstract Background Type 2 diabetes mellitus (T2DM) is a growing public health challenge in Pakistan, where poor glycemic control is common. Sodium–glucose co-transporter 2 (SGLT2) inhibitors, such as empagliflozin, have shown glycemic, cardiovascular, and renal benefits in controlled trials, but real-world data from low- and middle-income countries remain limited. This post-marketing surveillance (PMS) study evaluated the safety, tolerability, and effectiveness of Empagliflozin (Diampa ® ) alone and in combination with metformin (Diampa-M ® ), in Pakistani adults with T2DM. Methodology This multicenter, open-label, prospective, observational study included adults aged 18–65 years with T2DM, inadequate glycemic control (HbA1c 7–10%), and eGFR > 60 mL/min/1.73 m². Empagliflozin alone (10 mg or 25 mg) and in combination with Metformin were prescribed as per physician discretion and the patients were followed for 6 months. Primary endpoint was changes in HbA1c from baseline to 6 months. The secondary endpoints were FBS change, body weight change, body mass index (BMI) and safety outcome. Efficacy analyses were performed using a modified intention-to-treat (mITT) approach, and the missing follow-up values were addressed with the last observation carried forward (LOCF) method. Results Of the 952 enrolled participants, 765 (80.4%) completed the 6-month follow-up. A significant improvement in glycemic control was observed, median HbA1c decreased from 8.8% to 7.4% at 6 months ( p < 0.001). Greater HbA1c reduction was observed in the empagliflozin plus metformin group compared to monotherapy (median change: −1.10% vs. −0.60%; p < 0.001). There was a significant decrease in body weight; a median of 77.0 kg to 75.0 kg ( p < 0.001), systolic blood pressure and fasting blood glucose. Renal parameters were stable, and there was a slight increase in eGFR during the course of the study. The incidence of hypoglycemia was low, decreasing from 1.9% at 1 month to 0.5% at 6 months. Serious adverse events were uncommon (occurring in 0.5%, 0.4%, and 0.3% of participants at follow-ups respectively). Conclusion In routine clinical practice in Pakistan, Empagliflozin (Diampa ® ) alone and in combination with metformin (Diampa-M ® ) was generally well tolerated and was associated with improvements in glycemic control, body weight, and blood pressure, with preserved renal function over 6 months. Trial registration ClinicalTrials.gov ID NCT05164263; Date: 12/07/2021.