Efficacy and Safety of Sitagliptin Added to Insulin in Japanese Patients with Type 2 Diabetes: The EDIT Randomized Trial

• DOI: 10.1371/journal.pone.0121988
• Publication Date: 2015-03-29T02:39:50Z
• Authors: Seiji Sato; Yoshifumi Saisho; Kinsei Kou; Shu Meguro; Masami Tanaka; Junichiro Irie; Toshihide Kawai; Hiroshi Itoh
• Keywords: Glycated Hemoglobin; Male; Science; Q; Sitagliptin Phosphate; R; Middle Aged; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Diabetes Mellitus, Type 2; Japan; Patient Satisfaction; Medicine; Humans; Hypoglycemic Agents; Insulin; Drug Therapy, Combination; Female; Prospective Studies; Research Article; Aged

Aims To clarify the efficacy and safety of adding sitagliptin to insulin therapy in Japanese patients with suboptimally controlled type 2 diabetes (T2DM). Study Design Methods This was a 24-week, prospective, randomized, open-labeled, trial. Patients T2DM who were despite receiving at least twice daily injection enrolled study. The randomized continuation treatment (Insulin group) or addition 50 100 mg (Ins+Sita group). primary outcome change HbA1c week 24. Results Adding significantly reduced from 7.9 ± 1.0% baseline 7.0 0.8% 24 (P <0.0001), while there no significant Insulin group (7.8 0.7% vs. 7.8 1.1%, P = 0.32). difference reduction between groups 0.9% (95% confidence interval, 0.4 1.5, 0.01). There weight gain either group. Incidence hypoglycemia Ins+Sita compared Treatment satisfaction improved Baseline level beta cell function associated magnitude Conclusion without increase hypoglycemia, insulin. Trial Registration University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000004678