Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results

AIMS: This paper presents the treatment outcomes for patients intiated on biphasic insulin aspart 30 (BIAsp 30) treatment: BIAsp 30-only, BIAsp 30 + sulphonylureas (SU), BIAsp 30 + biguanides (BI), BIAsp 30 + SU + BI, BIAsp 30 + alpha-glucosidase inhibitors (GI), and BIAsp 30 + BI + thiazolidinediones (TZD) after failing oral antidiabetic drugs (OADs) treatment. METHODS: This was a multi-national, multi-centre, six-month, prospective, open-labelled, uncontrolled, clinical experience evaluation study, with the exception of a three-month study in one country (China) (“all exclude China” and “China”). Initiation and discontinuation of BIAsp 30 treatment were entirely at the discretion of the attending physicians. RESULTS: Mean HbA(1c), FPG and PPPG were significantly reduced from baseline at three and six months in all groups (P < 0.001). In “all exclude China”, reductions in mean HbA(1c), FPG and PPPG at six months were as follows: BIAsp 30-only group (−2.12 ± 1.76% points; −4.82 ± 3.86 mmol/L; −6.89 ± 4.74 mmol/L), BIAsp 30 + BI group (−2.24 ± 1.77% points; −4.48 ± 3.68 mmol/L; −6.66 ± 4.55 mmol/L), BIAsp 30 + SU group (−1.95 ± 1.59% points; −3.98 ± 3.19 mmol/L; −6.25 ± 4.45 mmol/L) and BIAsp 30 + SU + BI group (−1.78 ± 1.20% points; −3.57 ± 2.78 mmol/L; −5.89 ± 3.98 mmol/L). The only serious adverse drug reaction was reported by the BIAsp 30-only group. In the “China” group, reductions in mean HbA(1c), FPG and PPPG at three months were: BIAsp 30-only group (−2.16 ± 1.52% points; −3.34 ± 2.49 mmol/L; −6.29 ± 3.92 mmol/L), BIAsp 30 + BI group (−2.44 ± 1.52% points; −4.01 ± 2.50 mmol/L; −7.10 ± 3.96 mmol/L), BIAsp 30 + GI group (−2.33 ± 1.41% points; −4.34 ± 2.52 mmol/L; −7.97 ± 3.99 mmol/L) and BIAsp 30 + BI + TZD group (−1.21 ± 1.60% points; −3.50 ± 2.29 mmol/L; −5.97 ± 3.39 mmol/L). No serious ADR were reported in China. The most frequent hypoglycaemic episodes were diurnal and minor in nature. CONCLUSIONS: BIAsp 30 treatment in a clinical setting improved glycaemic control in type 2 diabetes patients failing OADs.