BIAsp 30 once daily is well tolerated and non-inferior to insulin glargine once daily both in combination with metformin and glimepiride in chinese and Japanese subjects with type 2 diabetes

Biphasic insulin aspart 30 (BIAsp 30) once daily (OD) as initiating insulin therapy can improve glycaemic control effectively and safely, but data in Asian populations is lacking. This open-labeled, randomized 24-week trial investigated the efficacy and safety of BIAsp 30 OD compared to insulin glargine (IGlar) OD in subjects with type 2 diabetes in China and Japan. Eligible insulin naive subjects entered a 3-week run-in period to optimize treatment of metformin and glimepiride, and were then randomized (1:1) to BIAsp 30 or IGlar group. A total of 521 subjects (mean +SD age: 56.3+9.6 yrs, BMI: 25.7+3.4kg/m², duration of diabetes: 9.4+6.9 yrs, baseline HbA_1c: 8.2+0.9%) were randomised. After 24 weeks of treatment, the estimated reductions in HbA_1c from baseline were 0.68% and 0.56% with BIAsp 30 and IGlar, respectively. BIAsp 30 was non-inferior to IGlar (estimated mean treatment difference [FAS]: -0.12 % [-0.25; 0.02] 95%CI). The percentage of subjects achieving HbA_1c<7% were comparable between the two groups (~30%). Mean 9-point self measured plasma glucose values generally decreased in both groups. Subjects treated with BIAsp 30 showed significantly lower mean plasma glucose (PG) levels at 2 hours after dinner, at bedtime and at 02:00 to 04:00 am in the following day. Subjects treated with IGlar had lower mean PG level before dinner. No safety concerns were raised in this trial. A total of 7 serious AEs (2 with BIAsp 30 and 5 with IGlar) were reported and only 1 was probably related to trial product (IGlar). The rates of hypoglycemic episodes and minor hypoglycemic episodes (PG value < 3.1 mmol/l) were generally low and comparable in both groups, and only 1 severe hypoglycemic episode was reported with IGlar. In conclusion, BIAsp 30 OD in combination with metformin and glimepiride was well tolerated and as effective as IGlar OD as measured by HbA_1c reduction.