[PMC free article] [PubMed] [Google Scholar] 21. indicate a statistically significant difference between groups. All analyses were performed using SAS version 9.4 (SAS, Cary, North Carolina). 3.?RESULTS 3.1. Patients Patient demographics and baseline disease characteristics were well balanced between the treatment groups in both the T1DM and T2DM populations (Table?S1). 5 , 10 The mean duration of T1DM or T2DM was more than 10?years. In ABES, most patients (77.2%) were receiving Lantus?\bolus prestudy treatment, while 12.9% and 9.9% of patients were receiving other basal\bolus and premixed insulins, respectively. In ABET, 67.0% patients were receiving two oral antihyperglycaemic medications before randomization and 71.5% patients were receiving sulphonylureas. Of the 272 patients with T1DM included in the ABES study who received 1 dose BOC-D-FMK of study medication, 210 (77.2%) reported prestudy use of IGlar and 35 (12.9%) reported prestudy use of other basal insulins. A total of 270 patients (LY IGlar: values for the interactions between TEAR and glycated haemoglobin (HbA1c) or basal insulin dose were calculated using an analysis of covariance (ANCOVA) model; conversation between TEAR and hypoglycaemia was calculated using a unfavorable binomial model. ?Adjusted for 1?12 months, events with blood glucose 3.9 mmol/L? included. IGlar, insulin glargine; LOCF, last observation carried forward; LY IGlar, LY2963016 insulin glargine No significant correlation was observed between total insulin antibody levels and efficacy outcomes (HbA1c, basal insulin dose [U/kg/d] or total hypoglycaemia [adjusted for 1?12 months]) at endpoint (LOCF) in patients with T1DM or T2DM (Physique?4A,B). Similarly, for patients with T1DM and T2DM, there was no significant conversation between detectable antibody levels at endpoint (LOCF) and change from baseline to endpoint (LOCF) in HbA1c (P?=?0.592 and P?=?0.849, respectively), basal insulin dose (U/kg/d; P?=?0.794 and P?=?0.982, respectively) or between overall detectable antibodies and overall total BOC-D-FMK hypoglycaemia (adjusted for 1?12 months; P?=?0.212 and P?=?0.316 [negative binomial model], respectively). Open in a separate window Physique 4 Relationship between total insulin antibody levels (percent binding) and efficacy outcomes (glycated haemoglobin [HbA1c], basal insulin dose and total hypoglycaemia rate adjusted for 1?12 months) at endpoint (Week 24, last observation carried forward [LOCF]) in A, patients with type 1 diabetes mellitus and B, patients with type 2 diabetes mellitus. ?Quantitative detection limit of the assay. ?Partial correlation measures of the relationship between endpoint measures (HbA1c, basal insulin dose or total hypoglycaemia rate) and endpoint antibody level after adjustment for baseline HbA1c, basal insulin at study entry, DKFZp781B0869 and prestudy metformin or acarbose usage. Only patients with nonmissing endpoint antibody levels and nonmissing baseline values, and with at least one nonmissing post\baseline value of the response variable, were included in the BOC-D-FMK analysis. IGlar, insulin glargine; LY IGlar, LY2963016 insulin glargine 3.4. Association between TEAR and safety outcomes No significant treatment\by\overall TEAR interactions were observed for the occurrence of treatment\emergent adverse events (TEAEs), TEAEs related to study drug, special topic assessment (allergic reactions and injection site events), injection site reactions (pain, pruritus and rash associated with the injection, or for the characteristics of the injection site [abscess, nodule, lipoatrophy, lipohypertrophy or induration]) or severe adverse events in patients with T1DM or T2DM (Table S3). However, for patients with BOC-D-FMK T1DM there were too few events of special topic assessment, injection site reactions or severe adverse events for the conversation test to be performed. Evaluation of adverse events by system organ classes and individual preferred terms in patients with TEAR revealed no clinically significant BOC-D-FMK treatment differences in.