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