Efficacy and safety of insulin glargine 300 U/<scp>mL</scp> vs insulin degludec in patients with type 2 diabetes: A randomized, open‐label, cross‐over study using continuous glucose monitoring profiles

Kawaguchi, Yuji; Sawa, Jun; Sakuma, Noriko; Kumeda, Yasuro

doi:10.1111/jdi.12884

Cited by 37 publications

(76 citation statements)

References 44 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: 90%

“…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]. Direct comparisons of Gla-300 and IDeg-100 in people with T1D are currently limited to two studies, neither of which used CGM.…”

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: 90%

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 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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“…This cross-over study was approved by the ethics committee of Minami Osaka Hospital and executed in accordance with the Declaration of Helsinki, with all patients providing informed consent. In the first of the two publications, the glargine U300 treatment period was associated with an overall lower percentage of time in a predefined hypoglycaemic range of \ 70 mg/dL (1.3% ± 2.7% [glargine U300] vs. 5.5% ± 6.4% [degludec]; p = 0.002) assessed by continuous glucose monitoring (CGM) over a 3-day period, with the authors concluding that glargine U300 carries a lower risk of hypoglycaemia [1]. It should be noted that recently published recommendations suggest longer CGM data collection periods for individuals with variable glycaemic control-for example, 4 weeks of data to investigate hypoglycaemia exposure [3].…”

mentioning

confidence: 99%

“…Kawaguchi et al have produced two publications of data from a small-scale cross-over study comparing insulin glargine 300 units/mL (glargine U300) with insulin degludec (degludec) in 30 patients with type 2 diabetes [1,2]. This cross-over study was approved by the ethics committee of Minami Osaka Hospital and executed in accordance with the Declaration of Helsinki, with all patients providing informed consent.…”

mentioning

confidence: 99%

Commentary to “Differential Effect of Hypoalbuminemia on Hypoglycemia on Type 2 Diabetes Patients Treated with Insulin Glargine 300 U/ml and Insulin Degludec” by Kawaguchi et al. Diabetes Therapy 2019

et al. 2020

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Efficacy and safety of insulin glargine 300 U/mL vs insulin degludec in patients with type 2 diabetes: A randomized, open‐label, cross‐over study using continuous glucose monitoring profiles

Abstract: The present study showed the comparable efficacy of Gla300 and Deg on glycemic control; however, the risk of hypoglycemia was markedly lower for Gla300 than for Deg.

Cited by 37 publications

References 44 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

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

Commentary to “Differential Effect of Hypoalbuminemia on Hypoglycemia on Type 2 Diabetes Patients Treated with Insulin Glargine 300 U/ml and Insulin Degludec” by Kawaguchi et al. Diabetes Therapy 2019

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