Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT ‐2 study
| العنوان: | Long‐term (52‐week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the |
|---|---|
| المؤلفون: | Hiroki Ikeda, Eiichi Araki, Nayyar Iqbal, Niki Arya, Hajime Maeda, Michiko Asano, Fredrik Thoren, Toshihiko Shiraiwa, Chantal Mathieu |
| المصدر: | Diabetes, Obesity & Metabolism |
| بيانات النشر: | Wiley, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | safety, Blood Glucose, medicine.medical_specialty, Diabetic ketoacidosis, type 1 diabetes, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Population, long‐term efficacy, 030209 endocrinology & metabolism, Subgroup analysis, 030204 cardiovascular system & hematology, Hypoglycemia, Placebo, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Double-Blind Method, Glucosides, Japan, Internal medicine, Japanese subpopulation, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Single-Blind Method, Benzhydryl Compounds, Dapagliflozin, education, Glycated Hemoglobin, Type 1 diabetes, education.field_of_study, business.industry, Blood Glucose Self-Monitoring, Original Articles, dapagliflozin, medicine.disease, Diabetes Mellitus, Type 1, Treatment Outcome, chemistry, Original Article, Drug Therapy, Combination, business, hypoglycaemia |
| الوصف: | Aim To examine the long‐term efficacy and safety of dapagliflozin, a sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor used to treat type 1 diabetes, in the Japanese subpopulation of the DEPICT‐2 study. Materials and Methods Patients with type 1 diabetes were randomized to dapagliflozin 5 mg (n = 55), dapagliflozin 10 mg (n = 41) or placebo (n = 58) plus insulin for a 24‐week, double‐blind period followed by a 28‐week, single‐blind extension phase. Results From baseline to 24 weeks, dapagliflozin reduced HbA1c compared with placebo (mean change of −0.58% and −0.80% for 5 and 10 mg, respectively), and an HbA1c reduction was observed up to 52 weeks. Compared with placebo, dapagliflozin 5 and 10 mg increased the proportion of patients achieving HbA1c reductions of 0.5% or more without severe hypoglycaemia events and reduced glycaemic variability assessed via continuous glucose monitoring. Both dapagliflozin doses decreased body weight and total daily insulin dose at 24 weeks compared with placebo; these reductions were maintained up to 52 weeks. Diabetic ketoacidosis occurred in both dapagliflozin groups (one and two cases, respectively) but not with placebo. Conclusions Efficacy and safety results from the Japanese subpopulation of the DEPICT‐2 study were generally consistent with those from the overall population, indicating that long‐term dapagliflozin adjunct to insulin therapy improves glycaemic control without an increased risk of hypoglycaemia but with a risk of diabetic ketoacidosis in Japanese patients with type 1 diabetes. |
| تدمد: | 1463-1326 1462-8902 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ecdd7c07f1a9ecbc384927fadd193496Test https://doi.org/10.1111/dom.14362Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....ecdd7c07f1a9ecbc384927fadd193496 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14631326 14628902 |
|---|