Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study

INTRODUCTION: MOSAIc was a multinational, non-interventional, prospective, observational cohort study designed to provide an understanding of the specific challenges associated with intensification of initial insulin therapy in patients with type 2 diabetes mellitus (T2DM). We present a sub-analysis of Japanese patients from MOSAIc, with data analyzed longitudinally over 2 years, to provide insight on how T2DM treatment is intensified. METHODS: Japanese patients with T2DM receiving any insulin therapy for at least 3 months were eligible for study inclusion. Baseline and clinical data were collected during an initial baseline visit and during four subsequent prospective visit windows (within ± 3 months) at 6, 12, 18, and 24 months. Treatment intensification was defined as addition of new insulin, increase in insulin dosage (1-unit change or 10% compared with the previous visit), increase in insulin injection frequency, and/or addition of non-insulin antihyperglycemic agents. RESULTS: Of 116 Japanese patients who completed the study, 50.0% (n = 58) received treatment intensification. Baseline characteristics of patients with treatment intensification included a longer duration of diabetes, higher incidence of baseline microvascular complications, and higher HbA1c compared to those without intensification. There was no significant difference in HbA1c change from baseline between the two groups at any post-baseline visit. Insulin intensification accounted for 61.2% of treatment changes, with non-insulin-related intensification accounting for 36.2% of treatment changes. An increase in insulin dose was the most frequent treatment change (51.7%), followed by the addition of new insulin (22.4%), and an increase in insulin injection frequency (6.9%). CONCLUSION: Real-world data from Japanese patients with T2DM who received treatment intensification showed that an increase in insulin dose and the addition of new insulin were the most frequent treatment intensification methods. HbA1c was maintained through 2 years of treatment. TRIAL REGISTRATION: NCT01400971, ClinicalTrials.gov.