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Effects of dapagliflozin compared with glimepiride on body composition in Asian patients with type 2 diabetes inadequately controlled with metformin: The BEYOND study
Authors:Hyeong Kyu Park MD  Kyoung-Ah Kim MD  Kyung-Wan Min MD  Tae-Seo Sohn MD  In Kyung Jeong MD  Chul Woo Ahn MD  Nan-Hee Kim MD  Ie Byung Park MD  Ho Chan Cho MD  Choon Hee Chung MD  Sung Hee Choi MD  Kang Seo Park MD  Seoung-Oh Yang MD  Kwan Woo Lee MD
Institution:1. Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea;2. Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University School of Medicine, Goyang, Korea;3. Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea;4. Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea;5. Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea;6. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea;7. Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea;8. Department of Internal Medicine, Gachon University School of Medicine, Incheon, Korea;9. Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea;10. Department of Internal Medicine, Wonju College of Medicine, Yonsei University, Wonju, Korea;11. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea;12. Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji University School of Medicine, Daejeon, Korea;13. Department of Nuclear Medicine, Semyung Christianity Hospital, Pohang, Korea;14. Department of Endocrinology and Metabolism, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea
Abstract:

Aims

To evaluate the effect of dapagliflozin on body composition such as total body fat (BF) mass, abdominal visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) areas compared with glimepiride in Korean patients with type 2 diabetes.

Materials and Methods

This was a 52-week, multicentre, randomized, parallel-group, open-label, Phase IV (NCT02564926) study. Patients with inadequate glycaemic control (glycated haemoglobin ≥7.0% and <10.0%) on metformin monotherapy (≥1000 mg/day) were randomized 1:1 to receive dapagliflozin 10 mg/day or glimepiride 1-2 mg/day for 12 months as an add-on to metformin. Baseline and end of study body composition evaluations included dual-energy X-ray absorptiometry and abdominal computed tomography scans.

Results

Of 124 enrolled patients from 14 centres, 121 received study treatment (dapagliflozin: 60; glimepiride: 61) and 106 (85.5%) completed the study. Over 52 weeks, the dapagliflozin group showed the following differences versus the glimepiride group: ?2.59 kg BF mass, ?1.94% BF%, ?17.55 cm2 VAT area, ?18.39 cm2 SAT area, ?0.46% glycated haemoglobin, ?18.25 mg/dl fasting blood glucose, ?3.7 kg weight, ?2.21 cm waist circumference, ?1.37 kg/m2 body mass index, ?6.81 mmHg systolic blood pressure and +657.71 ng/ml in adiponectin; all were statistically significant. Both groups had similar incidences of adverse events; however, hypoglycaemic events were mainly (12 of 15) reported in the glimepiride group.

Conclusion

Dapagliflozin reduced total BF mass, abdominal VAT and SAT areas, and showed better glycaemic control than glimepiride. Being safe and well-tolerated, dapagliflozin appears to be a more favourable alternative to sulphonylureas as add-on therapy after metformin monotherapy failure in Korean patients with type 2 diabetes.
Keywords:dapagliflozin  SGLT2 inhibitor  sulphonylureas  type 2 diabetes
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