Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: Experiences from the PRESENT study

Aim: The Physician's Routine Evaluation of Safety and Efficacy of NovoMix* 30 Therapy (PRESENT) aims to assess the safety and efficacy of biphasic insulin aspart (BIAsp30) used in routine clinical practice. Methods: This was a large, multi-national, multi-centre, prospective, 6-month study in type 2 diabetes mellitus patients who were prescribed BIAsp30. Efficacy endpoints included changes in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), and proportion who achieved target HbA 1c <7%. Changes from baseline were analysed using paired t-test. Safety endpoints were incidence and rate of hypoglycaemic episodes. A subgroup of patients previously uncontrolled (HbA1c ≥7.0%) on biphasic human insulin (BHI) were analysed. Results: Glycaemia improved significantly (mean ± SD): HbA1c by 1.58 ± 1.69% points (from 9.32 ± 1.64% to 7.70 ± 1.29%), FPG by 2.92 ± 3.71 mmol/L and PPPG by 4.75 ± 4.87 mmol/L. The incidence of hypoglycaemic episodes decreased over time, from 38.7% (baseline) to 20.8% (6 months). Episodes were mostly minor (reduced from 37.7 to 20.6% at 6 months), occurring during the day (reduced from 31.5 to 17.1% at 6 months). Major episodes were less frequently reported (reduced from 5.0 to 0.4% at 6 months). The rate of hypoglycaemia (episodes/patient year) from baseline to end of study decreased over time for overall (8.9-2.2), major (0.7-0.1), minor (8.2-2.2) and nocturnal (2.9-0.5) episodes. Conclusions: In this observational study, in the type 2 diabetes mellitus patients who were poorly controlled on BHI, glycaemia improved when transferred to BIAsp30, and a lower incidence or rate of hypoglycaemia was observed in these patients. © 2007 Librapharm Limited.