title: Safety and efficacy of insulin aspart and soluble human insulin in Type 2 diabetes mellitus.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine, University of Messina, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Cucinotta
authors.forename: S
authors.initials: S
authors.lastname: Caputo
authors.forename: E
authors.initials: E
authors.lastname: Mannucci
authors.forename: A
authors.initials: A
authors.lastname: Nicolucci
authors.forename: F
authors.initials: F
authors.lastname: Pellegrini
authors.forename: G
authors.initials: G
authors.lastname: Perriello
authors.forename: P
authors.initials: P
authors.lastname: Sbraccia
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D008687:Metformin