Sodium-glucose cotransporter-2 inhibitor luseogliflozin added to glucagon-like peptide 1 receptor agonist liraglutide improves glycemic control with bodyweight and fat mass reductions in Japanese patients with type 2 diabetes: A 52-week, open-label, singl
| Autor: | Daisuke Yabe, Soichi Sakai, Atsushi Fukatsu, Yutaka Seino, Hidekazu Ochiai, Takashi Sasaki, Hisae Imazeki |
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| Rok vydání: | 2017 |
| Předmět: |
Blood Glucose
Male Endocrinology Diabetes and Metabolism Type 2 diabetes 030204 cardiovascular system & hematology Gastroenterology chemistry.chemical_compound 0302 clinical medicine Japan Sorbitol Japanese patient Articles General Medicine Middle Aged Clinical Trial Treatment Outcome Clinical Science and Care Drug Therapy Combination Female Bioelectrical impedance analysis medicine.drug medicine.medical_specialty 030209 endocrinology & metabolism Hypoglycemia Glucagon-Like Peptide-1 Receptor 03 medical and health sciences Asian People Sodium-Glucose Transporter 2 Internal medicine Diabetes mellitus Weight Loss Internal Medicine medicine Humans Hypoglycemic Agents Add‐on to liraglutide Sodium-Glucose Transporter 2 Inhibitors Glycemic Glycated Hemoglobin business.industry Liraglutide medicine.disease Endocrinology Diabetes Mellitus Type 2 chemistry Lean body mass Luseogliflozin Glycated hemoglobin business |
| Zdroj: | Journal of Diabetes Investigation |
| ISSN: | 2040-1116 |
| DOI: | 10.1111/jdi.12694 |
| Popis: | Aims/Introduction The aim of the present study was to evaluate the safety and efficacy of luseogliflozin added to liraglutide monotherapy in Japanese individuals with type 2 diabetes. Materials and Methods This 52-week, multicenter, open-label, single-arm clinical study enrolled Japanese patients who had inadequate glycemic control with diet/exercise and liraglutide monotherapy. Major efficacy end-points included the changes from baseline in glycated hemoglobin, fasting plasma glucose and bodyweight. Body composition was also assessed in individuals who had access to bioelectrical impedance analysis. Safety assessments included adverse events, clinical laboratory tests, vital signs and 12-lead electrocardiograms. Results Of 76 patients who received luseogliflozin, 62 completed the study. The changes from baseline in glycated hemoglobin, fasting plasma glucose, and bodyweight (mean ± SE) were −0.68 ± 0.10%, −32.1 ± 3.6 mg/dL and −2.71 ± 0.24 kg at week 52, respectively (all, P < 0.001 vs baseline). Luseogliflozin was associated with greater reductions in fat mass than lean mass at all measuring points (n = 22): fat vs lean mass changes (mean ± SE) at week 52 were −2.49 ± 0.45 kg (P < 0.001 vs baseline) and −0.44 ± 0.26 kg (P = 0.107 vs baseline), respectively. Insulin secretion and Matsuda Index were also improved at weeks 12 and 52 compared with baseline. Adverse events and adverse drug reactions occurred in 65.8 and 27.6% of patients, respectively. The overall safety profile, including frequency of hypoglycemia, was found to be consistent with those of previous studies and there were no new safety concerns. Conclusions Luseogliflozin added to liraglutide was well tolerated, and improved glycemic control with bodyweight and fat mass reductions in Japanese type 2 diabetes patients. |
| Databáze: | OpenAIRE |
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