28-week, randomized, multicenter, open-label, parallel-group phase III trial to investigate the efficacy and safety of biphasic insulin aspart 70 thrice-daily injections vs twice-daily injections of biphasic insulin aspart 30 in patients with type 2 diabetes.

ABSTRACT: Aims/Introduction:? An insulin analogue formulation with a 7:3 ratio of rapid-acting and intermediate-acting fractions, biphasic insulin aspart 70 (BIAsp70) was developed to supplement basal insulin between meals and mimic the physiological pattern of postprandial insulin secretion.? We carried out a randomized, open-label study to compare the efficacy and safety profiles of BIAsp70 and an insulin analogue formulation with a 3:7 ratio of rapid-acting and intermediate-acting fractions (BIAsp30) in type 2 diabetes mellitus patients. Patients were randomized and received either thrice-daily BIAsp70 (n?=?145) or twice-daily BIAsp30 (n?=?144) for 28?weeks. The primary end-point was glycated hemoglobin (HbA1c) after 16?weeks of treatment.? Non-inferiority of BIAsp70 vs BIAsp30 was confirmed and superiority was established with a between-group difference (BIAsp70-BIAsp30) in HbA1c after 16?weeks of treatment of -0.35% (95% CI: -0.51 to -0.19; P?

SUBMITTER: Kadowaki T 

PROVIDER: S-EPMC4008024 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature