ECEESPE2025 Poster Presentations MTEabolism, Nutrition and Obesity (125 abstracts)
Efficacy of treatment with combination dapagliflozin and metformin vs metformin alone in overweight and obese women with polycystic ovary syndrome: a randomized controlled trial
Vishal Agarwal 1 , Sambit Das 1 , Arun Choudhury 1 , Dayanidhi Meher 1 , Devadarshini Sahoo 1 , Sandeep Sahu 1 , Subhadra Priyadarshini 2 , Binod Prusty 1 , Bijay Das 1 , Amogh Chappalagavi 1 & Sheenam Gupta 1
1Kalinga Institute of Medical Sciences, Endocrinology, Bhubaneshwar, India; 2Kalinga Institute of Medical Sciences, Research and development, Bhubaneshwar, India
JOINT2202
Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance and hyperandrogenemia, particularly in overweight and obese women. Dapagliflozin and other sodium-glucose cotransporter-2 (SGLT2) inhibitors may offer additional benefits to metformin, which is commonly used to improve metabolic parameters in patients with PCOS. This study compares the efficacy of metformin alone vs dapagliflozin plus metformin in reducing hyperandrogenism and insulin resistance in overweight and obese women with PCOS.
Methods: Sixty-four overweight or obese non-diabetic women between 18 and 40 years old diagnosed with polycystic ovary syndrome (PCOS) as per Rotterdam criteria were enrolled. Patients were randomly allocated to receive either a combination of dapaglifozin plus metformin (DAPA+MET) or metformin (MET) alone treatment. The DAPA+MET group received dapagliflozin 10 mg once daily plus metformin 1000 mg twice daily, while the MET group received metformin 1000 mg twice daily for six months. Changes in hormonal profile, anthropometric parameters, glucose and lipid homeostasis, and adverse events (AEs) were evaluated.
Results: At baseline, both groups had similar demographic, clinical and metabolic characteristics. Over 24 weeks, both groups showed significant reductions in body mass index (BMI), fasting insulin, fasting plasma glucose (FPG), homeostatic model assessment for insulin resistance (HOMA-IR), and androgenic markers like free androgen index (FAI) and serum testosterone levels (p < 0. 05 within groups). The DAPA+MET group demonstrated greater reductions in BMI (-1. 62 vs. -0. 42 kg/m2), fasting insulin (-1. 38 vs. -0. 74), HOMA-IR (-0. 51 vs. -0. 31), serum testosterone (-0. 12 vs. -0. 06), and FAI (-1. 21 vs. -0. 62) compared to metformin alone. However, the differences between groups were not statistically significant. Changes in lipid profiles were also comparable between groups. Adverse events such as urinary tract infections (UTI) and vaginal irritation were reported more frequently in the DAPA+MET group (P = 0. 043).
Conclusion: Both DAPA+MET and MET were effective in improving insulin resistance, hyperandrogenemia, and metabolic parameters in overweight and obese women with PCOS. While the combination therapy demonstrated greater improvements in weight loss and insulin sensitivity, the differences were not statistically significant. However, the increased incidence of UTIs and vaginal irritation should be considered when prescribing dapagliflozin in this population. Further long-term studies with larger sample sizes are needed to confirm the potential added benefits of dapagliflozin in managing PCOS.
Volume 110
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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