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  • Title: Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results.
    Author: Güler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, Shestakova M, Khutsoane D, Bech OM.
    Journal: Arch Drug Inf; 2009 Jun; 2(2):23-33. PubMed ID: 19684847.
    Abstract:
    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.
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