title: Comparison of morning basal + 1 bolus insulin therapy (insulin glulisine + insulin glargine 300 U/mL vs insulin lispro + insulin glargine biosimilar) using continuous glucose monitoring: A randomized crossover study.
abstract: BACKGROUND
  We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/mL (G + G300) with that of insulin lispro + insulin glargine biosimilar (L + GB).
  
  
  METHODS
  A total of 30 patients with type 2 diabetes who wore a continuous glucose monitoring device on admission after glucose levels were stabilized by morning long-acting and ultra-rapid-acting insulins were randomly allocated to groups who received G + G300 on days 1 and 2, and the same dose L + GB on days 3 and 4, or vice versa. Data collected on days 2 and 4 (mean amplitude of glycemic excursion, mean of daily differences: all days) were analyzed. Insulin was injected at 08.00 h. A day was defined as the period from 08.00 h one day, to 08.00 h the next day. Test meals were given.
  
  
  RESULTS
  Increased post-breakfast glucose level, post-breakfast glucose gradient, mean glucose level, standard deviation and M-value (24 h, 00.00-06.00 h), mean amplitude of glycemic excursion, and mean of daily differences were significantly lower in patients taking G + G300 than those taking L + GB (P ≤ 0.0001-0.04). The area over the glucose curve (<70 mg/dL) was not significantly different between groups. Pre-lunch - pre-breakfast glucose levels were significantly lower in patients taking L + GB than those taking G + G300 (P < 0.0001). The difference in the highest post-breakfast glucose level between groups (Δ = G + G300 - L + GB) was significantly correlated to 24-h mean glucose level (r = 0.40, P = 0.03).
  
  
  CONCLUSIONS
  Compared with L + GB, G + G300 decreases post-breakfast glucose level reducing rate of rise of that, nocturnal and 24-h glucose variability and level without causing hypoglycemia, and daily variance.
authors.affiliation: Department of Diabetes, General Inuyamachuo Hospital, Inuyama-city, Aichi, Japan.
authors.forename: Soichi
authors.identifier: http://orcid.org/0000-0002-4181-986X
authors.initials: S
authors.lastname: Takeishi
authors.affiliation: Department of Diabetes, General Inuyamachuo Hospital, Inuyama-city, Aichi, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Tsuboi
authors.affiliation: Department of Diabetes, General Inuyamachuo Hospital, Inuyama-city, Aichi, Japan.
authors.forename: Shodo
authors.initials: S
authors.lastname: Takekoshi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000627:therapeutic use*; D008297:Male; D019518:Postprandial Period; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro; D000069036:Insulin Glargine; C479079:insulin glulisine
keywords: Continuous glucose monitoring; Long-acting insulin; Ultra-rapid-acting insulin