Article ; Online: 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.
Diabetes, obesity & metabolism
2024 Volume 26, Issue 6, Page(s) 2248–2256
Abstract: 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 ... ...
| Abstract | 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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| MeSH term(s) | Humans ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/complications ; Benzhydryl Compounds/adverse effects ; Benzhydryl Compounds/therapeutic use ; Glucosides/adverse effects ; Glucosides/therapeutic use ; Glucosides/administration & dosage ; Metformin/adverse effects ; Metformin/therapeutic use ; Metformin/administration & dosage ; Female ; Middle Aged ; Male ; Drug Therapy, Combination/adverse effects ; Double-Blind Method ; Hypoglycemic Agents/adverse effects ; Hypoglycemic Agents/therapeutic use ; Hypoglycemic Agents/administration & dosage ; Glycated Hemoglobin/analysis ; Glycated Hemoglobin/metabolism ; Glycated Hemoglobin/drug effects ; Blood Glucose/drug effects ; Blood Glucose/metabolism ; Aged ; Treatment Outcome ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use ; Sodium-Glucose Transporter 2 Inhibitors/administration & dosage ; Hypoglycemia/chemically induced ; Hypoglycemia/epidemiology ; Adult ; Benzofurans | |||||
| Chemical Substances | Benzhydryl Compounds ; Glucosides ; dapagliflozin (1ULL0QJ8UC) ; Metformin (9100L32L2N) ; Hypoglycemic Agents ; Glycated Hemoglobin ; Blood Glucose ; Sodium-Glucose Transporter 2 Inhibitors ; hemoglobin A1c protein, human ; Enavogliflozin ; Benzofurans | |||||
| Language | English | |||||
| Publishing date | 2024-03-08 | |||||
| Publishing country | England | |||||
| Document type | Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Multicenter Study ; Comparative Study | |||||
| ZDB-ID | 1454944-x | |||||
| ISSN | 1463-1326 ; 1462-8902 | |||||
| ISSN (online) | 1463-1326 | |||||
| ISSN | 1462-8902 | |||||
| DOI | 10.1111/dom.15537 | |||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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