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

Yamada, Kentaro; Nakayama, Hitomi; Sato, Shuichi; Tajiri, Yuji; Kaku, Hiroh; Tokubuchi, Ichiro; Kato, Tamotsu; Soejima, Eri; Ohki, Tsuyoshi

doi:10.1007/s13340-013-0154-7

Cited by 10 publications

(16 citation statements)

References 7 publications

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“…Heise et al [ 8 ] reported that the use of insulin degludec resulted in lower day-to-day variability in blood glucose compared to insulin glargine in type 1 diabetes patients. However, different from this study, our results showed that switching to insulin degludec did not reduce MODD, an index of plasma glucose day-to-day variation, which was consistent with a previous study in Japan [ 13 , 14 ]. The precise reason for the inconsistency with the overseas study remains unknown.…”

Section: Discussionsupporting

confidence: 86%

Switching from Twice-Daily Basal Insulin Injections to Once-Daily Insulin Degludec Injection for Basal-Bolus Insulin Regimen in Japanese Patients with Type 1 Diabetes: A Pilot Study

Tosaka

Kanazawa

Ikeda

et al. 2015

International Journal of Endocrinology

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The aim of this study was to investigate the efficacy of insulin degludec used for basal-bolus insulin regimen after switching from twice-daily basal insulin in Japanese patients with type 1 diabetes mellitus. The subjects were 22 type 1 diabetes patients treated with basal-bolus insulin regimen with twice-daily basal insulin. Basal insulin was switched to once-daily injection of insulin degludec with 10% dose reduction. HbA1c and fasting plasma glucose (FPG) were measured before and 12 weeks after switching. The frequency of hypoglycemic episodes, standard deviation (SD) of blood glucose, and mean of daily difference (MODD) were evaluated by continuous glucose monitoring (CGM) before and 4 weeks after switching. HbA1c and FPG before and 12 weeks after switching were comparable (HbA1c 8.5 ± 1.4 versus 8.7 ± 1.6%, P = 0.28; FPG 203.2 ± 81.2 versus 206.5 ± 122.4 mg/dL, P = 0.91). The frequency of hypoglycemia during nighttime was not significantly different at 4 weeks after switching (14.4 ± 17.0 versus 11.1 ± 15.0%, P = 0.45). In addition, SD and MODD before and 4 weeks after switching were also comparable. In conclusion, glycemic control under once-daily insulin degludec injection was almost comparable to that under twice-daily basal insulin injections in Japanese type 1 diabetes patients. This study was registered with ID: UMIN000010474.

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Section: Discussionsupporting

confidence: 86%

Switching from Twice-Daily Basal Insulin Injections to Once-Daily Insulin Degludec Injection for Basal-Bolus Insulin Regimen in Japanese Patients with Type 1 Diabetes: A Pilot Study

Tosaka

Kanazawa

Ikeda

et al. 2015

International Journal of Endocrinology

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“…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].…”

Section: Discussionsupporting

confidence: 56%

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

et al. 2017

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“…Indeed, a previous study suggested that the bolus insulin requirement decreases when switching from insulin glargine to the same or a lower dose of insulin degludec. 11 Furthermore, in an earlier study that adjusted the basal and bolus insulin doses, the TDD and the total daily basal insulin dose were significantly lower, under equivalent glycemic control, with insulin degludec than with insulin glargine. 3 Although a direct comparison is impossible because we used a fixed basal insulin dose, it is possible that the TDD is lower with insulin degludec than with insulin glargine under equivalent glycemic control conditions.…”

Section: Discussionmentioning

confidence: 94%

Insulin Degludec Requires Lower Bolus Insulin Doses Than Does Insulin Glargine in Japanese Diabetic Patients With Insulin-Dependent State

Komuro

Inoue

Tabata

et al. 2014

J Diabetes Sci Technol

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Insulin degludec is a new-generation long-acting insulin analog that has stable and ultra-long glucose-lowering effects, as demonstrated using the euglycemic clamp technique.1,2 It has recently been approved for the treatment of diabetes in Europe and Japan. Insulin degludec is a soluble dihexamer preparation that forms stable soluble multihexamers after subcutaneous injection. These multihexamers are retained at the injection site for a short period of time before entering the blood stream in a slow and sustained manner by gradual dissolution with releasing monomers. They also bind with albumin via a fatty acid side chain at the injection site and in the blood, increasing the duration of the action. It has been reported that the frequency of nocturnal hypoglycemia was significantly lower in patients treated with insulin degludec than in patients treated with insulin glargine if overall glycemic control was equal.3-5 However, in the Food and Drug Administration review, 6 the advantageous effects of insulin degludec in nocturnal hypoglycemia were not apparent when patients with type 1 diabetes were analyzed alone or when the definition of the nighttime period was changed from 0:01-5:59 to 21:59-5:59 or to 0:01-7:59. Therefore, it is unclear whether insulin degludec is associated with a lower frequency of nocturnal hypoglycemia compared to insulin glargine. In addition, in a clamp study of The study presents a comparison of the glucose-lowering effects, glycemic variability, and insulin doses during treatment with insulin degludec or insulin glargine. Methods: In this open-label, single-center, 2-way crossover study, 13 Japanese diabetic outpatients in the insulin-dependent state on basal-bolus therapy were assigned to receive either insulin glargine followed by insulin degludec, or insulin degludec followed by insulin glargine. Basal insulin doses were fixed in principle, and patients self-adjusted their bolus insulin doses. Seventy-two-hour continuous glucose monitoring was performed 2 weeks after switching the basal insulin. Results: Mean blood glucose (mg/dL) was not significantly different between insulin degludec and insulin glargine over 48 hours (141.8 ± 35.2 vs 151.8 ± 43.3), at nighttime (125.6 ± 40.0 vs 124.7 ± 50.4), or at daytime (149.3 ± 37.1 vs 163.3 ± 44.5). The standard deviation (mg/dL) was also similar (for 48 hours: 48.9 ± 19.4 vs 50.3 ± 17.3; nighttime: 18.7 ± 14.3 vs 13.7 ± 6.7; daytime: 49.3 ± 20.0 vs 44.3 ± 17.7). Other indices of glycemic control, glycemic variability, and hypoglycemia were similar for both insulin analogs. Total daily insulin dose (TDD) and total daily bolus insulin dose (TDBD) were significantly lower with insulin degludec than with insulin glargine (TDD: 0.42 ± 0.20 vs 0.46 ± 0.22 U/ kg/day, P = .028; TDBD: 0.27 ± 0.13 vs 0.30 ± 0.14 U/kg/day, P = .036). Conclusions: Insulin degludec and insulin glargine provided effective and stable glycemic control. Insulin degludec required lower TDD and TDBD in this population of patients.

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

Cited by 10 publications

References 7 publications

Switching from Twice-Daily Basal Insulin Injections to Once-Daily Insulin Degludec Injection for Basal-Bolus Insulin Regimen in Japanese Patients with Type 1 Diabetes: A Pilot Study

Switching from Twice-Daily Basal Insulin Injections to Once-Daily Insulin Degludec Injection for Basal-Bolus Insulin Regimen in Japanese Patients with Type 1 Diabetes: A Pilot Study

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

Insulin Degludec Requires Lower Bolus Insulin Doses Than Does Insulin Glargine in Japanese Diabetic Patients With Insulin-Dependent State

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