Efficacy, safety and acceptability of the new pen needle 34G x 3.5 mm: randomized controlled crossover clinical trial

Introduction. Over the past years, the insulin administration modalities in patients with diabetes have evolved, leading to the manufacturing of progressively smaller in length and caliber needles, to reduce pain and fear for injections and ensuring the same metabolic control and safety

Aims. The AGO. 02 study has been designed to assess the non-inferiority of the new pen needle Pic Insupen G34x3,5mm compared to the pen needle Pic Insupen 4mm with gauge 32, on metabolic control expressed by fructosamine levels. Additional endpoints are glycemic variability, insulin need, satisfaction, pain, leakage at the point of injection and incidence of hypoglycemia

Type of study. Open-label, randomized, multi-center, two periods cross-over, non-inferiority with 3-week treatment periods

Population. 80 subjects with diabetes type 1 and 2 in multi-injective insulin treatment

Centers. 4 Italian diabetes centers

Promoter. Artsana SpA

Funding. Artsana SpA

Status. Ongoing study