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
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Le résumé fourni par la source
AIM: To 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 METHODS: After 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. RESULTS: Eighty-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). CONCLUSIONS: Enavogliflozin 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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- A 52‐week efficacy and safety study of enavogliflozin versus dapagliflozin as an add‐on to metformin in patients with type 2 diabetes mellitus: <scp>ENHANCE‐M</scp> extension study
- Date Crossref
- 08/03/2024
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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The Catholic University of Korea Uijeongbu St. Mary's Hospital pays non établi dans la noticeÉtablissement de santé
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Catholic University of Korea Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
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Eulji University Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
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Eulji University Nowon Eulji Medical Center pays non établi dans la noticeÉtablissement de santé
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Bundang Jesaeng Hospital Division of Endocrinology and Metabolism pays non établi dans la noticeÉtablissement de santé
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Yonsei University Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
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Severance Hospital pays non établi dans la noticeÉtablissement de santé
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Gangnam Severance Hospital pays non établi dans la noticeÉtablissement de santé
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Kyung Hee University Division of Endocrinology and Metabolism pays non établi dans la noticeUniversité ou école supérieure
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Kyung Hee University Dental Hospital pays non établi dans la noticeÉtablissement de santé
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Kyung Hee University Hospital at Gangdong pays non établi dans la noticeÉtablissement de santé
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Hallym University Dongtan Sacred Heart Hospital Division of Endocrinology and Metabolism pays non établi dans la noticeÉtablissement de santé
The Catholic University of Korea Uijeongbu St. Mary's Hospital, Department of Internal Medicine — Catholic University of Korea et Department of Internal Medicine — Eulji University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.