Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in insulin-naïve type 2 diabetes: Design and...

Area of Science:

• Endocrinology
• Diabetes Management
• Pharmacology

Background:

• Basal insulin therapy can improve glucose control in Type 2 Diabetes Mellitus (T2DM).
• Barriers exist for initiating, titrating, and monitoring basal insulin in T2DM patients.
• Patient self-management of insulin therapy may overcome these barriers.

Purpose of the Study:

• To demonstrate non-inferiority of patient-managed versus physician-managed titration of insulin glargine 300 U/mL (Gla-300) in T2DM patients.
• To assess glucose control efficacy (HbA1c change) after 24 weeks using a standardized titration algorithm.
• To evaluate the effectiveness of patient-led basal insulin management in a real-world setting.

Main Methods:

• The Italian Titration Approaches Study (ITAS) was a phase IV, multicenter, randomized controlled trial.
• 458 insulin-naïve T2DM patients with uncontrolled diabetes were enrolled.
• Patients were randomized (1:1) to either nurse-assisted patient management or physician management of Gla-300 titration for 24 weeks.

Main Results:

• Baseline characteristics included mean age 64.0 years, T2DM duration 11.6 years, and HbA1c 8.79%.
• Most patients (73.8%) had vascular disorders and (58.3%) metabolic disorders.
• Over 90% of patients were previously treated with metformin.

Conclusions:

• The ITAS study is the first to compare patient-led vs. physician-led Gla-300 titration in T2DM.
• Results may provide evidence for the efficacy and effectiveness of patient-managed basal insulin titration.
• This approach has the potential to reduce barriers to initiating and titrating basal insulin therapy.