A 52‐week efficacy and safety study of enavogliflozin versus dapagliflozin as an add‐on to metformin in patients with type 2 diabetes mellitus: ENHANCE‐M extension study

Author:

Sohn Tae Seo1,Han Kyung‐Ah2,Kim Yonghyun3,Lee Byung‐Wan4ORCID,Chon Suk5ORCID,Jeong In‐Kyung6ORCID,Hong Eun‐Gyoung7ORCID,Son Jang Won8,Na JaeJin9,Cho Jae Min9,In Cho Seong9,Huh Wan9,Yoon Kun‐Ho10ORCID

Affiliation:

1. Division of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu St Mary's Hospital, College of Medicine The Catholic University of Korea Uijeongbu South Korea

2. Division of Endocrinology and Metabolism, Department of Internal Medicine, Nowon Eulji Medical Center Eulji University Seoul South Korea

3. Division of Endocrinology and Metabolism, Department of Internal Medicine Bundang Jesaeng Hospital Seongnam South Korea

4. Division of Endocrinology and Metabolism, Department of Internal Medicine, Severance Hospital Yonsei University College of Medicine Seoul South Korea

5. Division of Endocrinology and Metabolism, Department of Internal Medicine Kyung Hee University Hospital Seoul South Korea

6. Division of Endocrinology and Metabolism, Department of Internal Medicine Kyung Hee University Hospital at Gangdong Seoul South Korea

7. Division of Endocrinology and Metabolism, Department of Internal Medicine Hallym University Dongtan Sacred Heart Hospital Hwaseong South Korea

8. Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital, College of Medicine The Catholic University of Korea Bucheon South Korea

9. Clinical Development Center Daewoong Pharmaceutical Co. Ltd Seoul South Korea

10. Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine The Catholic University of Korea Seoul South Korea

Abstract

AbstractAimTo evaluate the long‐term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus.Materials and MethodsAfter 24 weeks of a randomized, double‐blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open‐label extension period.ResultsEighty‐two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28‐week open‐label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p < .0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p < .0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose‐creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p < .0001).ConclusionsEnavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose‐creatinine ratio.

Funder

Daewoong Pharmaceutical Company

Publisher

Wiley

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