title: Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results.
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.
authors.forename: Serdar
authors.initials: S
authors.lastname: Güler
authors.forename: Surendra Kumar
authors.initials: SK
authors.lastname: Sharma
authors.forename: Majeed
authors.initials: M
authors.lastname: Almustafa
authors.forename: Chong Hwa
authors.initials: CH
authors.lastname: Kim
authors.forename: Sami
authors.initials: S
authors.lastname: Azar
authors.forename: Rucsandra
authors.initials: R
authors.lastname: Danciulescu
authors.forename: Marina
authors.initials: M
authors.lastname: Shestakova
authors.forename: Duma
authors.initials: D
authors.lastname: Khutsoane
authors.forename: Ole Molskov
authors.initials: OM
authors.lastname: Bech
references.citation: Lancet. 1998 Sep 12;352(9131):837-53
references.pmid: 9742976
references.citation: Diabetes Care. 2002 Feb;25(2):330-6
references.pmid: 11815505
references.citation: Eur J Clin Pharmacol. 2000 Aug;56(5):399-403
references.pmid: 11009049
references.citation: Diabet Med. 2002 May;19(5):393-9
references.pmid: 12027927
references.citation: Drugs. 2006;66(1):31-49
references.pmid: 16398567
references.citation: Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003418
references.pmid: 15495054
references.citation: JAMA. 1999 Jun 2;281(21):2005-12
references.pmid: 10359389
references.citation: Clin Ther. 2005;27 Suppl B:S42-56
references.pmid: 16519037
references.citation: Diabet Med. 2006 Jun;23(6):579-93
references.pmid: 16759299
references.citation: Clin Ther. 2003 Dec;25(12):3109-23
references.pmid: 14749149
references.citation: Diabetes Care. 2005 Feb;28(2):260-5
references.pmid: 15677776
references.citation: Ann Intern Med. 1988 Mar;108(3):334-40
references.pmid: 3124685
references.citation: Exp Clin Endocrinol Diabetes. 1998;106(5):369-72
references.pmid: 9831300
references.citation: Diabetes Care. 2003 Jan;26 Suppl 1:S28-32
references.pmid: 12502617
references.citation: Diabetes Obes Metab. 2003 Nov;5(6):446-54
references.pmid: 14617231
references.citation: Diabetes Obes Metab. 2008 Mar;10(3):212-22
references.pmid: 18269636
references.citation: Diabetes Care. 2006 Aug;29(8):1963-72
references.pmid: 16873813
references.citation: Diabetes Obes Metab. 2006 Jan;8(1):39-48
references.pmid: 16367881
references.citation: J Diabetes Complications. 2003 Nov-Dec;17(6):307-13
references.pmid: 14583174
references.citation: Eur J Intern Med. 2004 Dec;15(8):496-502
references.pmid: 15668084