title: Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study.
abstract: BACKGROUND
  New insulin glargine 300 U mL(-1) (Gla-300) is a basal insulin that shows more stable and prolonged pharmacokinetic and pharmacodynamic profiles than insulin glargine 100 U mL(-1) (Gla-100). This study used continuous glucose monitoring (CGM) to compare 24-h glucose profiles in a Japanese population using Gla-300 versus Gla-100.
  
  
  METHODS
  This was an exploratory 8.4-week, single-center, 2-sequence, 2-period, open-label crossover study. Japanese adults with type 1 diabetes mellitus (T1DM) treated with basal-bolus insulin, with glycated hemoglobin (HbA1c) 6.5-10.0% and median fasting self-monitored plasma glucose concentration ≤13 mmol L(-1), were randomized to Gla-300 followed by Gla-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 glucose variability (area under the curve [AUC]mean_24 h) on the second day of each CGM measurement with Gla-300 versus Gla-100. Baseline and end of treatment period values for HbA1c, fasting plasma glucose (FPG) and daily basal/mealtime insulin doses were recorded. Hypoglycemia and adverse events (AEs) were recorded.
  
  
  RESULTS
  Twenty participants were randomized (10 to subgroup 1 and 10 to subgroup 2). Participants showed comparable glucose variability over 24 h (AUCmean_24 h during treatment with Gla-300 or Gla-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 participants experiencing ≥1 hypoglycemia event at any time (24 h) and at night (00:00-05:59 h) with Gla-300 versus Gla-100. Treatment-emergent AEs, reported by 9/20 (45%) and 4/20 (20%) participants during Gla-300 and Gla-100 treatment, respectively, were unrelated to study medication.
  
  
  CONCLUSIONS
  In this cohort of Japanese people with T1DM, no between-treatment difference was observed in glucose variability with Gla-300 versus Gla-100, as measured by CGM. There was a trend for less hypoglycemia with Gla-300, particularly at night, versus Gla-100. Both treatments were well tolerated.
  
  
  BACKGROUND
  Sanofi, Tokyo, Japan.
  
  
  BACKGROUND
  NCT01676233, ClinicalTrials.gov.
authors.affiliation: Jinnouchi Hospital, Kumamoto, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Jinnouchi
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Koyama
authors.forename: Atsushi
authors.initials: A
authors.lastname: Amano
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Akira
authors.initials: A
authors.lastname: Yoshida
authors.forename: Kunio
authors.initials: K
authors.lastname: Hieshima
authors.forename: Seigo
authors.initials: S
authors.lastname: Sugiyama
authors.forename: Noboru
authors.initials: N
authors.lastname: Kurinami
authors.forename: Tomio
authors.initials: T
authors.lastname: Jinnouchi
authors.forename: Reinhard
authors.initials: R
authors.lastname: Becker