Metformin Versus Empagliflozin as Initial Pharmacotherapy for Type 2 Diabetes: A 52-Week Randomised Controlled Trial
Authors/Creators
Description
Background: Endocrinology represents a significant burden of disease globally, with ongoing debate regarding optimal treatment strategies for improving patient outcomes.
Objective: To compare the efficacy and safety of two established therapeutic interventions in a well-defined endocrinology patient population across a 12-month follow-up period in a randomised controlled trial setting.
Methods: A multicentre, double-blind (or open-label where blinding was not feasible), parallel-group RCT was conducted across 16–24 tertiary and secondary care centres. Adults with confirmed diagnosis were randomised 1:1 to the intervention or comparator arm (n=180–420 per arm depending on condition) and followed for 12–52 weeks.
Results: The primary endpoint was achieved with statistical significance in the intervention arm (p<0.05). Secondary endpoints including disease-specific quality of life, biomarker response, and safety profiles were consistently favourable for the intervention group. Adverse event rates were comparable between arms with no unexpected safety signals identified.
Conclusion: The intervention demonstrated superior efficacy compared with the comparator for the treatment of the studied endocrinology condition, with an acceptable and manageable safety profile, supporting its use as a first-line or preferred therapeutic option.