110-LB: The Korean Titration: A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 Units/ml in Patients with Uncontrolled Type 2 Diabetes

Background: In the Canadian TITRATION study, the INSIGHT algorithm was as effective as the EDITION algorithm for insulin dose titration in patients with type 2 diabetes. However, these algorithms have not been evaluated in Asian patients. Objective: To compare the efficacy and safety of two algorithms, the INSIGHT and EDITION, for insulin glargine 300 units/mL (Gla-300) in patients with uncontrolled type 2 diabetes treated with basal insulin Methods: The Korean TITRATION was a 12-week, single-center, open-label, randomized, treat-to-target, and pragmatic trial. We randomly assigned 130 patients to either the INSIGHT (self-titration by 1 unit/day) or EDITION (self-titration no more than every 3 days) groups to achieve a fasting self-monitored blood glucose (SMBG) in the range of 4.4 to 5.6 mmol/L. The primary endpoint was a proportion of patients reaching fasting SMBG ≤5.6 mmol/L without hypoglycemia. Results: A total of 129 patients were included in the study. At week 12, patients achieving the primary endpoint were 24.6% (INSIGHT) and 23.4% (EDITION) (P = 0.961). Fasting SMBG were 102.0 mg/dL (INSIGHT) and 111.2 mg/dL (EDITION) (P = 0.110). Proportions of patients with HbA1c ≤7% were 23.1% (INSIGHT) and 20.3% (EDITION) (P = 0.867). There was no difference in changes in fasting plasma glucose, HbA1c, and body weight between the two groups. Mean changes in total daily insulin doses were significantly higher in the INSIGHT group than in the EDITION group (12.83 units/day vs. 6.81 units/day, P = 0.030). However, the incidence of hypoglycemia was comparable between the two groups. In addition, adherence to the algorithm tended to be higher in the INSIGHT group than in the EDITION group (45.7% vs. 35.9%, P = 0.109). Conclusion: The self-titration of Gla-300 with the INSIGHT algorithm is effective and safe compared to that with the EDITION algorithm in Korean patients with uncontrolled type 2 diabetes. Disclosure J. Bae: None. C. Ahn: None. Y. Yang: None. S. Moon: None. S. Kwak: None. H. Jung: None. K. Park: None. Y. Cho: None.