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Minerva Endocrinologica 2012 December;37(4):357-66


language: English

Safety and efficacy of insulin aspart and soluble human insulin in Type 2 diabetes mellitus

Cucinotta D. 1, Caputo S. 2, Mannucci E. 3, Nicolucci A. 4, Pellegrini F. 4, 5, Perriello G. 6, Sbraccia P. 7

1 Department of Internal Medicine, University of Messina, Messina, Italy; 2 Diabetological Unit, Policlinico Gemelli, Sacro Cuore Catholic University, Rome, Italy; 3 Department of Cardiovascular Medicine, Section of Geriatric Cardiology, Careggi University Hospital, Florence, Italy; 4 Department of Clinical Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy; 5 Unit of Biostatistics, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy; 6 Section of Internal Medicine, Endocrinology and Metabolism, Department of Internal Medicine, University of Perugia, Perugia, Italy; 7 Department of Internal Medicine, University of Rome Tor Vergata, Rome, Italy


AIM: The UpGrade study evaluated the safety profile and effectiveness of insulin aspart (IAsp, NovoRapid®) and soluble human insulin (SHI) in patients with Type 2 diabetes mellitus, under current clinical practice conditions.
METHODS: This 26-week, open-label, non-randomized, observational safety study recruited patients using insulin ± metformin and having received ≥2 injections of IAsp or SHI over a period of 3 months to 3 years. Data were collected via patient recall and treatment diaries, at baseline, 13- and 26-week visits. The number of major hypoglycemic episodes was the primary endpoint. Secondary endpoints were minor hypoglycemic episodes, HbA1c, fasting and post-prandial blood glucose.
RESULTS: Overall, 4099 patients were included. At study end the incidence of major hypoglycemia was low (mean rate 0.117 ev/pt-y) and rates were lower in subjects using IAsp compared with those using SHI, for both major (0.115 vs. 0.121) and minor (6.648 vs. 9.530) episodes. IAsp correlated with a significantly lower risk of minor hypoglycemic episodes (IRR=0.64, P<0.0001). Overall, HbA1c levels decreased across 26 weeks (7.97% to 7.63%, P<0.0001); IAsp had greater HbA1c reduction than SHI (–0.39% and –0.22%, respectively) and was associated with a marginally significant likelihood (vs. SHI) of achieving HbA1c reduction of ≥0.5% (OR=1.22, P=0.059).
CONCLUSION: Under current clinical practice conditions, treatment of patients with Type 2 diabetes mellitus using either IAsp or SHI resulted in low rates of major hypoglycemia after 26 weeks. Patients using IAsp had a better clinical safety profile and a greater reduction in HbA1c compared with patients using SHI.

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