Biphasic insulin aspart 30 plus metformin in patients with type 2 diabetes inadequately controlled on basal insulin therapy:An evaluation of efficacy and safety

Objective To evaluate the efficacy and safety of biphasic insulin aspart 30 (BIAsp30)plus metformin in type 2 diabetes subjects switching from basal insulin plus oral antidiabetic drugs (OAD)Methods During 16 weeks, multiple-center, open-label, and single-arm study including 2 weeks of screening period,4 weeks of run-in period,and 16 weeks of treatment period were carried out. Subjects with type 2 diabetes mellitus inadequately controlled on basal insulin therapy with or without oral antidiabetic drugs were switched to twice-daily BIAsp30 plus metformin with dose titration to achieve fasting plasma glucose target. Results Of the 293 Chinese subjects exposed to trial drugs [age: ( 54.0±9.6 ) years, diabetes duration: ( 8.54±5.49 ) years, body mass index: (24.89±3.28)kg/m2, baseline HbA1c: 8.16% ±0.89%], 122 were previously treated with basal insulin analogues and 169 with human basal insulin. At end of the trial ,the mean reduction of HbA1 c was 1.30% ±0.96% (P＜0. 01 ). The proportion of patients achieved HbA1c＜7.0% and HbA1c ≤6.5% was 60.4% and 38.9% respectively. 8-point plasma glucose measurements showed significant improvements at all the time points examined ( all P＜0. 01 ) ,and the average value of all 8 points measured decreased from ( 10.53±2.58 ) mmol/L atbaseline to (7.79± 1.58 ) mmol/L at the end of treatment ( P＜0. 01 ), reduced by 2.76 mmol/L. Postprandial glucose increments were significantly reduced after breakfast ( -1.73 mmol/L,P＜0.01 )and dinner ( -1.28 mmol/L,P＜0.01 ), while no significant reduction was observed after lunch ( -0.09 mmol/L, P = 0. 734 5 ). No severe adverse effect and no major hypoglycemia were reported. The overall hypoglycaemia rate was 2.68 events/subject year. The average weight gain was (0. 76 ±0. 14 )kg (P＜0. 0l ). Conclusion Twice-daily BIAsp30 plus metformin is effective and safe to type 2 diabetic subjects inadequately controlled on basal insulin treatment.BIAsp30 treatment should be considered for type 2 diabetic subjects who have unsatisfactory response to previous basal insulin treatment. Key words: Diabetes mellitus, tyre 2;  Insulin aspart;  Metformin