PMID- 26055218
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150624
LR  - 20231111
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 6
IP  - 2
DP  - 2015 Jun
TI  - 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.
PG  - 143-52
LID - 10.1007/s13300-015-0115-1 [doi]
AB  - 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 (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. 
      FUNDING: Sanofi, Tokyo, Japan. CLINICAL TRIAL REGISTRATION: NCT01676233, 
      ClinicalTrials.gov.
FAU - Jinnouchi, Hideaki
AU  - Jinnouchi H
AD  - Jinnouchi Hospital, Kumamoto, Japan.
FAU - Koyama, Masayoshi
AU  - Koyama M
FAU - Amano, Atsushi
AU  - Amano A
FAU - Takahashi, Yoshinori
AU  - Takahashi Y
FAU - Yoshida, Akira
AU  - Yoshida A
FAU - Hieshima, Kunio
AU  - Hieshima K
FAU - Sugiyama, Seigo
AU  - Sugiyama S
FAU - Kurinami, Noboru
AU  - Kurinami N
FAU - Jinnouchi, Tomio
AU  - Jinnouchi T
FAU - Becker, Reinhard
AU  - Becker R
LA  - eng
SI  - ClinicalTrials.gov/NCT01676233
PT  - Journal Article
DEP - 20150609
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC4478173
EDAT- 2015/06/10 06:00
MHDA- 2015/06/10 06:01
PMCR- 2015/06/09
CRDT- 2015/06/10 06:00
PHST- 2015/04/16 00:00 [received]
PHST- 2015/06/10 06:00 [entrez]
PHST- 2015/06/10 06:00 [pubmed]
PHST- 2015/06/10 06:01 [medline]
PHST- 2015/06/09 00:00 [pmc-release]
AID - 115 [pii]
AID - 10.1007/s13300-015-0115-1 [doi]
PST - ppublish
SO  - Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 
      Jun 9.