Continuous @entity413 Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300  U  mL(-1) and Glargine 100  U  mL (-1) in Japanese @entity1 with XXXX : A Crossover Pilot Study.

@entity1 @entity9984 @entity6 @entity4053 @entity413
INTRODUCTION: New insulin glargine 300 U  mL(-1) ( @entity9984 -300) is a basal insulin that shows more stable and prolonged pharmacokinetic and pharmacodynamic profiles than insulin glargine 100  U  mL(-1) ( @entity9984 -100). This study used continuous @entity413 monitoring (CGM) to compare 24-h @entity413 profiles in a Japanese population using @entity9984 -300 versus @entity9984 -100. METHODS: This was an exploratory 8.4-week, single-center, 2-sequence, 2-period, open-label crossover study. Japanese adults with @entity6 ( @entity6 ) treated with basal-bolus insulin, with glycated hemoglobin (HbA1c) 6.5-10.0% and median fasting self-monitored plasma @entity413 concentration  <=13  mmol  L(-1), were randomized to @entity9984 -300 followed by @entity9984 -100 (subgroup 1) or vice versa (subgroup 2), with no washout period. CGM was performed on the last 3  days of the screening period and each treatment period. Primary endpoint was comparison of 24-h @entity413 variability (area under the curve [AUC]mean_24  h) on the second day of each CGM measurement with @entity9984 -300 versus @entity9984 -100. Baseline and end of treatment period values for HbA1c, fasting plasma @entity413 (FPG) and daily basal/mealtime insulin doses were recorded. @entity4053 and adverse events (AEs) were recorded. RESULTS: Twenty @entity1 were randomized (10 to subgroup 1 and 10 to subgroup 2). @entity1 showed comparable @entity413 variability over 24  h (AUCmean_24  h during treatment with @entity9984 -300 or @entity9984 -100 (treatment ratio 0.96; 90% confidence interval 0.79, 1.16). HbA1c and FPG were generally stable across both treatment periods. There was a trend towards fewer @entity1 experiencing >= 1 @entity4053 event at any time (24  h) and at night (00:00-05:59  h) with @entity9984 -300 versus @entity9984 -100. Treatment-emergent AEs, reported by 9/20 (45%) and 4/20 (20%) @entity1 during @entity9984 -300 and @entity9984 -100 treatment, respectively, were unrelated to study medication. CONCLUSIONS: In this cohort of Japanese @entity1 with @entity6 , no between-treatment difference was observed in @entity413 variability with @entity9984 -300 versus @entity9984 -100, as measured by CGM. There was a trend for less @entity4053 with @entity9984 -300, particularly at night, versus @entity9984 -100. Both treatments were well tolerated. FUNDING: Sanofi, Tokyo, Japan. CLINICAL TRIAL REGISTRATION: NCT01676233, ClinicalTrials.gov.
