Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in insulin-naïve type 2 diabetes: Design and population
- Bonadonna R. C.
- Giaccari A.
- Buzzetti R.
- Aimaretti G.
- Cucinotta D.
- Avogaro A.
- Perseghin G.
- Larosa M.
- Bolli G. B.
- Fanelli C. G.
DOIAbstract
Background and aims: Fostering patient's self-managing of basal insulin therapy could improve glucose control, by removing patient's and physician's barriers to basal insulin initiation, titration and glucose monitoring. The Italian Titration Approaches Study (ITAS) aims at demonstrating 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 versus the physician, in insulin naïve patients with Type 2 Diabetes Mellitus (T2DM), uncontrolled with previous treatments. Methods and results: ITAS is a phase IV, 24-week, national, multicenter, open label, randomized (1:1) para...
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