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

INTRODUCTION: 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 (HbA(1c)) 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 HbA(1c), 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 (AUC(mean_24 h) during treatment with Gla-300 or Gla-100 (treatment ratio 0.96; 90% confidence interval 0.79, 1.16). HbA(1c) 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. FUNDING: Sanofi, Tokyo, Japan. Clinical trial registration: NCT01676233, ClinicalTrials.gov. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0115-1) contains supplementary material, which is available to authorized users.