Efficacy and safety of monotherapy with enavogliflozin in Korean patients with type 2 diabetes mellitus: Results of a 12‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase 2 trial
Rattachement africain : kr, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
AIMS: The study aimed to evaluate and compare the efficacy and safety of enavogliflozin, a newly developed sodium-glucose cotransporter 2 inhibitor, with placebo in Korean patients with type 2 diabetes mellitus. MATERIALS AND METHODS: Patients with glycated haemoglobin (HbA1c) of 7.0-10.0%, entered a 2-week placebo run-in period, and were randomized to receive once-daily enavogliflozin (0.1, 0.3 or 0.5 mg) or placebo for 12 weeks. The primary efficacy endpoint was the change in HbA1c from baseline at week 12. RESULTS: Overall, 194 patients were included in the full analysis set [placebo, n = 46; enavogliflozin (0.1 mg, n = 49; 0.3 mg, n = 50; 0.5 mg, n = 49)]. Patients receiving 0.1, 0.3 and 0.5 mg enavogliflozin showed significantly reduced HbA1c compared with those receiving placebo at week 12 (-0.79%, -0.89%, -0.92% and -0.08%, respectively; p < .001 vs. placebo). Mean changes in fasting plasma glucose from baseline at week 12 were -30.5, -31.1, -35.0 and 4.9 mg/dl in patients receiving enavogliflozin doses and placebo, respectively. The proportion of patients achieving HbA1c <7.0% at week 12 was significantly higher in the three enavogliflozin groups than in the placebo group (42.9%, 44.0%, 61.2% and 17.4%, respectively). A higher proportion of patients showed HbA1c reduction by >0.5% after receiving enavogliflozin doses than those receiving placebo (61.2%, 72.0%, 65.3% and 26.1%, respectively). There were no significant differences in incidences of adverse events of hypoglycaemia and genital infection between the groups. CONCLUSIONS: Once-daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well-tolerated treatment for Korean patients with type 2 diabetes mellitus.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Efficacy and safety of monotherapy with enavogliflozin in Korean patients with type 2 diabetes mellitus: Results of a 12‐week, multicentre, randomized, double‐blind, placebo‐controlled, phase 2 trial
- Date Crossref
- 24/04/2023
- 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
-
Seoul National University Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
-
Seoul National University Bundang Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
-
Eulji University pays non établi dans la noticeUniversité ou école supérieure
-
Eulji University Nowon Eulji Medical Center pays non établi dans la noticeÉtablissement de santé
-
Sungae Hospital pays non établi dans la noticeÉtablissement de santé
-
CHA University Bundang Medical Center pays non établi dans la noticeÉtablissement de santé
-
CHA University Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
-
Hallym University Kangnam Sacred Heart Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
-
Sacred Heart Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
-
Hallym University Dongtan Sacred Heart Hospital pays non établi dans la noticeÉtablissement de santé
-
Changwon National University pays non établi dans la noticeUniversité ou école supérieure
-
Daegu Fatima Hospital pays non établi dans la noticeÉtablissement de santé
Department of Internal Medicine — Seoul National University Hospital, Department of Internal Medicine — Seoul National University Bundang Hospital et Eulji University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.