Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in insulin-naïve type 2 diabetes: Design and population
Nutrition, Metabolism & Cardiovascular Diseases Apr 06, 2019
Bonadonna RC, et al. – In the 24-week Italian Titration Approaches Study (ITAS), researchers established the non-inferiority (< 0.3% margin) in efficacy of glucose control (change in glycated hemoglobin [HbA1c] after 24 weeks) by the same titration algorithm of insulin glargine 300 U/mL (Gla-300), managed by the (nurse assisted) patient vs the physician, in insulin naïve patients with type 2 diabetes mellitus (T2DM), uncontrolled with previous treatments. Of 460 enrolled patients, 359 were randomized, and 339 completed the study. Vascular and metabolic disorders occurred most frequently. Metformin was present in 97.5% of participants and sulfonylureas were present in 27.9% of patients. Overall, this study provide novel evidence on the efficacy/effectiveness of patient-managed titration algorithm of Gla-300 in a pragmatic setting, and may reduce barriers to basal insulin initiation and its titration.
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