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, Yuka; Kanazawa, Akio; Ikeda, Fuki; Iida, Madoka; Sato, Junko; Matsumoto, Kazuhisa; Uchida, Toyoyoshi; Tamura, Yasuaki; Ogihara, Takeshi; Mita, Tomoya; Shimizu, Tomoaki; Goto, Hiromasa; Ohmura, Chie; Fujitani, Yoshio; Watada, Hirotaka

doi:10.1155/2015/176261

Cited by 11 publications

(7 citation statements)

References 18 publications

(21 reference statements)

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“…Several previous studies have evaluated the changes in glycemic variability, measured by CGM, in DM1 patients who switched to IDeg. Three studies did not find significant changes in GV, or in 24-h analyses, or in nocturnal measurements [15] , [16] , [17] , compared with the study of Iga [18] where improvements in day-to-day variability measurements were observed, but not changes in MAGE or in J-index. In a cross-over study, where a 24 h analysis of CMG was performed, a statistically significant decrease in the standard deviation was observed for patients receiving IDeg, compared to those receiving Insulin Detemir twice a day [19] .…”

Section: Discussionmentioning

confidence: 80%

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Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes

Henao

Velandía

Gómez

et al. 2018

Journal of Clinical & Translational Endocrinology

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SummaryIntroductionDegludec (IDeg) is an ultralong-acting insulin, with stable pharmacodynamic profile which leads to lower fluctuations in glucose levels. The effect of IDeg has not been specifically assessed in patients with unstable diabetes, defined as increased glycemic variability (GV).MethodsA prospective before-after pilot study was conducted, including patients managed at Hospital Universitario San Ignacio in Bogotá, Colombia. The impact of the switch from a Glargine or Detemir insulin to a basal insulin regimen with IDeg for 12 weeks on GV measured by continuous glucose monitoring, on A1c levels, and on the incidence of episodes of global and nocturnal hypoglycemia was assessed in a group of patients with (coefficient of variation >34%) or without increased basal GV using a Generalised Estimating Equation (GEE) analysis.Results60 patients with basal bolus therapy and history of hypoglycemia were included. 18 patients had High GV (HGV). In this group a significant reduction of 11.1% of CV (95% CI: 6.3, 15.9, p = 0.01) was found. GEE analysis confirmed a higher impact over time on patients with HGV (p < 0.001). The percentage of patients with at least 1 episode of hypoglycemia decreased from 66.6% to 22.2% (p = 0.02) and from 37.14% to 5.71% (p < 0.01) for global and nocturnal hypoglycemia, respectively. Changes were not significant in patients with low GV. A reduction of A1c was observed in both groups (p < 0.001).ConclusionsThe results suggest that treatment with IDeg reduces GV, A1c levels and the incidence of global and nocturnal hypoglycemia events in patients with HGV, but not in patients with low GV.

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Section: Discussionmentioning

confidence: 80%

“…Regarding glycemic control, previous studies in patients with DM1 have shown a minimum impact, which ranges from small reductions in A1c levels [15] , [24] , to an absence of changes [16] , [18] . Similar results were found when comparing IDeg to glargine in patients with DM2 who were insulin naïve [25] , [22] .…”

Section: Discussionmentioning

confidence: 95%

Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes

Henao

Velandía

Gómez

et al. 2018

Journal of Clinical & Translational Endocrinology

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“…Degludec insulin has been reported to improve glucose control through a decrease in glycaemic variability and hypoglycaemic episodes and a decrease of insulin doses, notably in the maintenance period ( 14 , 16 , 32 ). In addition, a decrease in insulin requirement and an improvement of HbA1c has also been observed in patients switched from glargine to degludec, even though these results are still quite discordant ( 33 , 34 ).…”

Section: Discussionmentioning

confidence: 97%

Improved Cardiovascular and Cardiometabolic Risk in Patients With Type 1 Diabetes and Autoimmune Polyglandular Syndrome Switched From Glargine to Degludec Due to Hypoglycaemic Variability

et al. 2018

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Background: Cardiovascular disease is a frequent complication of type 1 diabetes (T1D). We evaluated the effectiveness of switching from glargine to degludec in reducing the cardiovascular risk factors, the Framingham risk score (FRS) and visceral adiposity index (VAI) in patients with T1D and autoimmune polyglandular syndrome (APS).Methods: We selected 66 T1D outpatients who had been on stable treatment with glargine for at least 5 years. Among them, 30 patients maintained glargine (group A), while 36 were switched to degludec (group B) for 12 months. At baseline and after 12 months of observation, clinical and metabolic parameters, insulin dose, 30-days blood glucose (BG) self monitoring, VAI and FRS were obtained.Results: At baseline, patients in group B had more hypoglycaemic episodes and prevalence of hypertension than those in group A. After 12 months on degludec, patients in group B had a significant decrease in BMI (p = 0.003), waist circumference (p < 0.001), total daily insulin as U/day and U/kg (p = 0.001 for both), basal insulin as U/day and U/kg (p = 0.001 for both), HbA1c (p < 0.001), mean (p = 0.035) and standard deviation of daily BG (p = 0.017), mean pre-meal BG (p = 0.016), number of hypoglycaemic episodes (p = 0.001), VAI (p = 0.012) and FRS (p = 0.019) and a significant increase in HDL-C (p < 0.001), compared to baseline. At 12 months of treatment a significant decrease in BMI (p = 0.017), WC (p = 0.003), SBP (p = 0.001), DBP (p = 0.005), basal insulin as U/day (p = 0.018) and U/kg (p = 0.045), HbA1c (p = 0.040) and FRS (p = 0.010) was observed in group B compared to group A.Conclusions: Our preliminary data suggest that 12 months' treatment with degludec is associated with an improvement of glycaemic control, cardiometabolic and cardiovascular risk, compared to glargine, in patients with T1D and APS.

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“…32,38 In addition, the settings in which participants were monitored varied across studies, with some participants admitted in a hospital setting to control for the potential influence of diet and exercise, 27,32 while others were conducted in an ''outpatient'' setting. 39,[44][45][46] The majority of studies identified were also of short duration, with some studies being only 6-15 days long 27,32,47 and the majority being between 8 and 12 weeks long; this period of time will likely not enable sufficient data on hypoglycemia events to be captured to enable statistical comparisons and is not long enough to fully explore the efficacy and safety profile of basal insulins, particularly during the maintenance phase of treatment, where minimal dose adjustments are made. Further limitations of CGM studies identified in the present analysis included the small population sizes (with most direct comparison studies having fewer than 30 participants in each treatment arm), or with sample sizes being derived from subpopulations of larger RCTs, such as the BEGIN YOUNG study; thus these studies may have had insufficient statistical power to detect key outcomes.…”

Section: Cgm Data Comparing First-and Second-generation Basal Insulinmentioning

confidence: 99%

Comparison of Second-Generation Basal Insulin Analogs: A Review of the Evidence from Continuous Glucose Monitoring

Battelino

Edelman

Nishimura

et al. 2021

Diabetes Technology & Therapeutics

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Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events, despite improvements in therapeutic strategies. While glycated hemoglobin (HbA 1c) is currently recognized as the gold-standard for assessing glycemic control, the measure reflects mean blood glucose levels over a period of time, does not inform on acute glycemic deviations, and can be unreliable in certain populations. Continuous glucose monitoring (CGM) facilitates the acquisition of blood glucose data around the clock and, importantly, predicts and/or captures acute hyper-and hypoglycemic episodes. In light of the recent publication of the Time in Range (TIR) International Consensus Group report on key CGM metrics, we performed a review of current CGM evidence for second-generation basal insulins in both people with type 1 and type 2 diabetes. The identified studies highlight the varied CGM-related metrics used to assess basal insulins, which complicate comparisons. Furthermore, all studies had small sample sizes and typically were of short duration, which may account for the lack of statistically significant between-treatment differences observed. Differences were seen in the titration approaches used and the settings in which participants were observed. These results highlight the need for further studies of secondgeneration basal insulin analogs that are designed to capture the standard metrics proposed by the TIR consensus group, with additional consideration given to sample size and study duration.

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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

Cited by 11 publications

References 18 publications

Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes

Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes

Improved Cardiovascular and Cardiometabolic Risk in Patients With Type 1 Diabetes and Autoimmune Polyglandular Syndrome Switched From Glargine to Degludec Due to Hypoglycaemic Variability

Comparison of Second-Generation Basal Insulin Analogs: A Review of the Evidence from Continuous Glucose Monitoring

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