Comparison of insulin glargine 300 U/<scp>mL</scp> and insulin degludec using flash glucose monitoring: A randomized cross‐over study

Yamabe, Mizuho; Kuroda, Mami; Hirosawa, Yasuyo; Kamino, Hiromi; Ohno, Haruya; Yoneda, Masayasu

doi:10.1111/jdi.12894

Cited by 27 publications

(50 citation statements)

References 29 publications

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“…A second head-to-head study conducted in adults with T2D already receiving insulin did not demonstrate superiority for IDeg-100 versus Gla-300 during the maintenance period [16]. To our knowledge, two small studies have been published that compare Gla-300 and IDeg-100 in people with T2D using CGM, both conducted in Japan [17,18]. Yamabe et al reported no statistically significant difference between the two insulins in any of the CGM metrics assessed, including mean TIR, mean time below range (TBR; both \ 70 and \ 54 mg/dL) and mean coefficient of variation (CV; a CV of \ 36% is taken to represent stable glycaemia [18,19].…”

Section: Introductionmentioning

confidence: 92%

“…To our knowledge, two small studies have been published that compare Gla-300 and IDeg-100 in people with T2D using CGM, both conducted in Japan [17,18]. Yamabe et al reported no statistically significant difference between the two insulins in any of the CGM metrics assessed, including mean TIR, mean time below range (TBR; both \ 70 and \ 54 mg/dL) and mean coefficient of variation (CV; a CV of \ 36% is taken to represent stable glycaemia [18,19]. However, Kawaguchi et al observed significantly lower anytime (24 h) and nocturnal (0000-0600 hours) CV and TBR with Gla-300 than with IDeg-100 [17].…”

Section: Introductionmentioning

confidence: 99%

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InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring—Study Design

et al. 2020

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Introduction: Suboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro-and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper-and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need.

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Section: Introductionmentioning

confidence: 92%

Section: Introductionmentioning

confidence: 99%

InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring—Study Design

et al. 2020

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“…In the BRIGHT trial, event rates of anytime and nocturnal confirmed hypoglycemia were lower with IGla-300 than with IDeg during the initial titration period (0-12 weeks) [23]. Recently, Yamabe et al also reported that the incidence of nocturnal hypoglycemia, of which patients might be unaware, with IGla-300 (n = 24) was significantly lower than that with IDeg (n = 24) in crossover study using a flush glucose monitoring (FGM) system [27]. The low-level hypogly-cemia might have been overlooked in our study because of lacking daily glucose profile by FGM or continuous glucose monitoring, we might underestimate the frequency of hypoglycemia unawareness but did not observe any serious episodes of hypoglycemia throughout the observation.…”

Section: Discussionmentioning

confidence: 98%

Comparison of the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) and long-acting second-generation basal insulin (insulin degludec and insulin glargine 300 units/mL) in insulin-naïve Japanese adults with type 2 diabetes: a pilot, randomized, controlled study

Shimoda

Sakamoto²,

Hokamura

et al. 2019

Endocr J

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To examine the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) or once-daily secondgeneration basal insulin analogs (insulin degludec and insulin glargine 300 units/mL) in insulin-naïve Japanese adults with type 2 diabetes in routine clinical practice. A 12-week multicenter, open-label, randomized, pilot study was performed in 52 subjects with type 2 diabetes treated with oral antidiabetic drugs (OADs). Subjects were randomized to once-daily IDegAsp (n = 26) or basal insulin (n = 26). The primary endpoint was percent change in HbA1c from baseline to week 12. Furthermore, it was analyzed post hoc in subgroups stratified by baseline HbA1c. During a follow-up period, percent change in HbA1c was not significantly different between the two groups (p = 0.161). Daily insulin doses and frequency of overall hypoglycemia were also similar in the two groups. In post hoc analyses, once-daily basal insulin was more effective than IDegAsp in subjects with HbA1c more than or equal to 8.5% (p < 0.05); however, in subjects with HbA1c less than 8.5%, once-daily IDegAsp showed a significant improvement in percent change in HbA1c at week 12, compared with basal insulin (p < 0.01). Although there was no apparent difference in the HbA1c-lowering effects between two groups, when compared in subjects with HbA1c less than 8.5%, once-daily IDegAsp showed a significant effect in comparison with once-daily basal insulin. These findings suggest that the baseline HbA1c level might provide the important information for choosing IDegAsp or basal insulin in patients insufficiently controlled with OADs. This trial was registered with UMIN (no. UMIN000035431).

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“…In addition, it was reported that Gla-300 has lower possibility of hypoglycaemia than Gla-100 and insulin degrudec [43][44][45][46] . The peak of Gla-300 was reported to be lower than Gla-100 and presented 12-13 h later 46 .…”

Section: Discussionmentioning

confidence: 99%

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

Nakashima

Okamura

Sanefuji

et al. 2020

Sci Rep

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the aim is to devise a new short-term intensive insulin therapy (n-Siit) based on the concept of "treat to target" to avoid hypoglycaemia and was applied it to various diabetic state. We determined dosage of 1 basal and 3 bolus "treat" insulin based on "target" blood glucose level and changed each insulin dose by small units (2 units) every day for 2 weeks. We evaluated the effects of N-SIIT in 74 subjects with type 2 diabetes (male 45, female 29, 64.9 ± 16.6 years old, HbA1c 10.4 ± 2.6%). Glargine U300 ("treat") and morning blood glucose level ("target") was significantly correlated with increasing insulin dose and decreasing blood glucose level in day 1-7, indicating that insulin amount was determined by target blood glucose level and lowered next target blood glucose level. Remission rates were 67.3% (Hypoglycaemia rate 5.6 %) in N-SIIT and 47.3% (Hypoglycaemia rate 38.1%) in conventional SIIT. Required amount of insulin would be automatically determined, depending on each patient pathophysiology and life style. This method is pretty simple, flexible and cheap, and provides information about the dynamic pathophysiological alteration of insulin resistance and glucotoxicity from the profile of blood glucose levels and insulin shot.Type 2 diabetes mellitus (T2DM) is a progressive disease which gradually reduces pancreatic beta-cell function such as insulin secretory capacity and increases insulin resistance in various insulin target tissues 1,2 . Recently, short-term intensive insulin therapy (SIIT) is recommended in the treatment of newly diagnosed T2DM to eliminate glucotoxicity, to reduce beta-cell overload (beta-cell rest effect), to support residual beta-cells and to enhance insulin sensitivity 3-18 .In addition, pancreatic alpha-cell dysfunction may contribute to the metabolic dysfunction found in diabetic state, because post-prandial paradoxical hyperglucagonaemia leads to the elevation of blood glucose levels 19,20 . SIIT may also improve alpha-cell physiology 21-23 . Indeed, it is possible that stepwise addition of insulin leads to the reduction of hyperglucagonaemia.The evidence of this treatment has been presented to prove benefits in the treatment of T2DM. However, in most SIIT studies, after SIIT they did not use any anti-diabetic agents and evaluated the duration of glycaemic remission [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] . As the results, glycaemic remission was temporary, especially when beta-cell function was markedly deteriorated after SIIT. Retnakaran et al. regarded SIIT as an induction therapy and sequential treatment with anti-diabetic agents as a maintenance therapy 24 . Several kinds of anti-diabetic agents such as metformin or GLP-1 receptor activator had been used for a maintenance therapy, but sometimes re-induction of insulin therapy was necessary [24][25][26][27] . We used conventional SIIT for the elimination of glucotoxicity in clinical practice and thought that SIIT was useful not only in newly diagnosed T2DM but also under many kinds of diabetes conditions to ...

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Comparison of insulin glargine 300 U/mL and insulin degludec using flash glucose monitoring: A randomized cross‐over study

Cited by 27 publications

References 29 publications

InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring—Study Design

InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring—Study Design

Comparison of the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) and long-acting second-generation basal insulin (insulin degludec and insulin glargine 300 units/mL) in insulin-naïve Japanese adults with type 2 diabetes: a pilot, randomized, controlled study

Practical application of short-term intensive insulin therapy based on the concept of “treat to target” to reduce hypoglycaemia in routine clinical site

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