Effects of insulin degludec and insulin glargine on day-to-day fasting plasma glucose variability in individuals with type 1 diabetes: a multicentre, randomised, crossover study

Abstract

Aims/hypothesisWe compared the effects of insulin degludec (IDeg; Des(B30)LysB29(γ-Glu Nε-hexadecandioyl) human insulin) and insulin glargine (IGlar; A21Gly,B31Arg,B32Arg human insulin) on the day-to-day variability of fasting plasma glucose (FPG) levels in individuals with type 1 diabetes treated with basal-bolus insulin injections.MethodsThe effects of basal-bolus insulin therapy for 4 weeks with either IDeg or IGlar as the basal insulin in adult C-peptide-negative outpatients with type 1 diabetes were investigated in an open-label, multicentre, randomised, crossover trial. Randomisation was conducted using a centralised allocation process. The primary endpoints were the SD and CV of FPG during the final week of each treatment period. Secondary endpoints included serum glycoalbumin level, daily dose of insulin, intraday glycaemic variability and frequency of severe hypoglycaemia.ResultsThirty-six randomised participants (17 in the IDeg/IGlar and 19 in the IGlar/IDeg groups) were recruited, and data for 32 participants who completed the trial were analysed. The mean (7.74 ± 1.76 vs 8.56 ± 2.06 mmol/l; p = 0.04) and SD (2.60 ± 0.97 vs 3.19 ± 1.36 mmol/l; p = 0.03) of FPG were lower during IDeg treatment than during IGlar treatment, whereas the CV did not differ between the two treatments. The dose of IDeg was smaller than that of IGlar (11.0 ± 5.2 vs 11.8 ± 5.6 U/day; p < 0.01), but other secondary endpoints did not differ between the treatments.Conclusions/interpretationIDeg yielded a lower FPG level and smaller day-to-day variability of FPG at a lower daily dose compared with IGlar in participants with type 1 diabetes. IDeg serves as a good option for basal insulin in the treatment of type 1 diabetes.Trial registration: University Hospital Medical Information Network 000009965.Funding: This research recieved no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes

“…The 2-year extension of the main BEGIN trial [22] indicated that the hypoglycemia-reducing benefits of IDeg were observed at night, rather than during the day; this is likely because a relationship exists between bolus insulin and diurnal hypoglycemia, whereas the ultra-long acting and less variable glucose-lowering effects of IDeg may better decrease nocturnal hypoglycemia. Some other studies [9,13,[17][18][19][23][24][25][26], including our recent study [14], also demonstrated a greater reduction in the risk of nocturnal hypoglycemia, rather than an overall decrease, with IDeg in all-aged patients with type 1 diabetes. The outcomes of an earlier 1-year study of IDeg in Japanese adults with type 2 diabetes were consistent with our observations [11].…”

“…In the present study, the daily dose of IDeg was numerically decreased, but did not significantly differ during the 24-week study period relative to the baseline; therefore, the administration of a conservative dose is recommended in children of age<15 years with type 1 diabetes upon switching from IGlar previously given once daily to IDeg. Subsequently, this dose can be adjusted according to the patient's blood glucose levels to avoid occurrence of hypoglycemia [9,11,18,19,[24][25][26]. The dose-adjustment could affect a risk of hypoglycemia.…”

Efficacy and safety of switching from insulin glargine to insulin degludec in young people with type 1 diabetes

“…In recent Japanese reports, Kusunoki et al [27] demonstrated that PG levels during evening time tended to decrease after switching to IDeg from other Las as evaluated by CGM in patients with once-daily injection of La at baseline. Nakamura et al [28] showed that the mean and SD of FPG were significantly smaller at lower dose of insulin with IDeg than with IGlar in a multicenter, randomised, crossover study for adults with type 1 diabetes. On the other hand, Thalange et al [17] similarly reported that significant decrease of FPG with lower dose of insulin was observed with IDeg than with IDet in children and adolescents with type 1 diabetes.…”

“…The reduction rate was remarkable in patients receiving twice-daily injections of basal insulin (76.0% of the value at baseline) as compared with those given oncedaily injections (82.6% of the value at baseline) before IDeg use. Previous studies of adults with type 1 diabetes have recommended reducing the dose of IDeg by <10-20% for patients who previously received oncedaily injection of IGlar, and by 20-40% for those previously given twice-daily injections [14,25,[26][27][28]. By contrast, Yamada et al [29] reported that there was no need to reduce the dose of IDeg from those given initially in Japanese adults with type 1 diabetes.…”

Short-Acting Insulin Reduction Strategies for Continuous Cycle Ergometer Exercises in Patients with Type 1 Diabetes Mellitus

“…In the last few years, a novel ultra-long-acting insulin has been developed (insulin degludec (IDeg) (®Tresiba/ Novo Nordisk, Bagsvaerd, Denmark)). A recent study has shown that intensive insulin therapy with IDeg is related to less frequent nocturnal hypoglycemic events (13), lower levels and smaller day-to-day variability of fasting plasma glucose (14) while implementing a lower daily insulin dose (15). It also showed a comparable symptomatic and cognitive response to artificially induced hypoglycemia (16) Copyright © 2017, Sports Medicine Research Center.…”