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

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.