Abstract
Purpose:
This study aimed to evaluate the safety and efficacy of Empagliflozin (Diampa→) alone & with Metformin (Diampa-M→) in patients with Type 2 Diabetes Mellitus (T2DM).
Methods:
This open-label, prospective, observational study was conducted in three hospital-based settings in South Asia. A total of 215 patients aged 18–65 years, with T2DM and HbA1c levels between 7.0% and 10%, were enrolled. The participants were monitored over 6 months, with follow-up visits at 1, 3, and 6 months. Primary outcomes included clinical and laboratory parameters such as weight, blood pressure, HbA1c, fasting blood sugar (FBS), and renal function markers. Secondary outcomes focused on adverse events and treatment discontinuation.
Results:
Significant improvements were observed in clinical and laboratory parameters. Median weight decreased from 75 kg to 74 kg (P = 0.000), and systolic and diastolic blood pressure improved significantly (SBP: P = 0.003, DBP: P = 0.022). Glycemic control also improved, with HbA1c reducing from 8.75% to 7.90% (P = 0.000), and FBS decreased from 149.0 mg/dL to 132.0 mg/dL (P = 0.000). Renal function markers showed mixed results: serum creatinine decreased significantly (P = 0.003), and estimated glomerular filtration rate (eGFR) increased from 109.0 to 112.4 mL/min/1.73 m² (P = 0.000). The frequency of adverse events, including hypoglycemia, dehydration, and urinary tract infections, decreased over time. Serious adverse events were reported in five participants at 1 month, 4 at 3 months, and 3 at 6 months. Treatment discontinuation was observed in four participants at 1 month, 1 at 3 months, and none at 6 months.
Conclusions:
Empagliflozin (Diampa→) alone & with Metformin (Diampa-M→) was effective in improving glycemic control, weight, and blood pressure in South-Asian patients with T2DM. The drug demonstrated a generally favorable safety profile, with adverse events decreasing over time.
Keywords
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