Effects of Insulin Degludec and Insulin Glargine U300 on Day-to-Day Fasting Plasma Glucose Variability in Individuals with Type 1 Diabetes: A Multicenter, Randomized, Crossover Study (Kobe Best Basal Insulin Study 2)

Miura, Hiroki; Sakaguchi, Kazuhiko; Okada, Yuko; Otowa‐Suematsu, Natsu; Yamada, Tomoko; So, Anna; Komada, Hisako; Hirota, Yushi; Kishi, Minoru; Takeda, Akihiko; Tominaga, Yoshihiro; Nakamura, Tomoaki; Kuroki, Yasuo; Matsuda, Tomokazu; Iida, Keiji; Kajikawa, Michiko; Ohara, Takeshi; Yokota, Kazuki; Hara, Kenta; Tateya, Sanshiro; Tamori, Yoshikazu; Ogawa, Wataru

doi:10.1007/s13300-018-0523-0

Cited by 3 publications

(14 citation statements)

References 17 publications

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“…The Kobe Best Basal Insulin Study 2 was an 8-week, multicenter, randomized, open-label, cross-over, comparative study involving 46 C-peptide-negative adult outpatients with T1D randomly assigned (1:1) to Gla-300 (first period)/iDeg (second period) or iDeg (first period)/Gla-300 (second period). 24 This study found that iDeg-100 was non-inferior to Gla-300 with respect to fasting glucose SD (assessed using SMBG; primary endpoint). There were also no significant differences in CGM-assessed SD, CV, M-value, mean amplitude of glycemic excursions (MAGE), TIR and mean of daily difference (MODD).…”

Section: Randomized Controlled Trialsmentioning

confidence: 74%

“…[15][16][17][18][19] Several randomized controlled trials (RCTs) involving Gla-300 in people living with T1D have included measures of glycemic variability. [20][21][22][23][24] In addition, one study has reported real-world evidence (RWE) on glycemic variability in people treated with Gla-300. 25 There is a lack of longer term prospective studies using CGM and of studies comparing second-generation basal insulin.…”

Section: Glycemic Variability and Guidance On The Use And Interpretat...mentioning

confidence: 99%

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Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Mader

Gölz²,

Bilz

et al. 2022

BMJ Open Diab Res Care

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Short-term glycemic variability is associated with the risk of hypoglycemia and hyperglycemia in people living with type 1 diabetes and can potentially affect clinical outcomes. Continuous glucose monitoring (CGM) is of increasing importance to evaluate glycemic variability in greater detail. Specific metrics for assessing glycemic variability were proposed, such as the SD of mean glucose level and associated coefficient of variation, and time in target glucose range to guide study designs, therapy and allow people with diabetes more transparency in interpreting their own CGM data. Randomized controlled trials (RCT) and real-world evidence provide complementary information about the efficacy/effectiveness and safety of interventions. Insulin glargine 300 U/mL (Gla-300) has a longer lasting and less variable action than insulin glargine U100 (Gla-100) with a lower risk of hypoglycemia. While insulin degludec U100 (iDeg-100) was associated with lower glucose values but more time below range in one randomized study compared with Gla-300, Gla-300 was associated with a higher per cent time in range, but also above the therapeutic range. However, a real-world study did not find differences during the day between Gla-300 and iDeg-100. The upcoming InRange RCT is the first head-to-head comparison of Gla-300 with iDeg-100 using CGM in an international population using CGM metrics as the primary endpoint. The non-interventional COMET-T real-world study will determine the real-world effectiveness of Gla-300 using CGM metrics and cover a broad spectrum of clinical practice decisions irrespective of the prior basal insulin.

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Section: Randomized Controlled Trialsmentioning

confidence: 74%

Section: Glycemic Variability and Guidance On The Use And Interpretat...mentioning

confidence: 99%

Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Mader

Gölz²,

Bilz

et al. 2022

BMJ Open Diab Res Care

View full text Add to dashboard Cite

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“…The study protocol was described previously 28 . In brief, participants had to satisfy all the inclusion criteria and not meet any exclusion criteria, as described in Table S1.…”

Section: Methodsmentioning

confidence: 99%

“…As described in detail previously, 28 according to a preliminary analysis of day‐to‐day variability in FBG levels for individuals with type 1 diabetes treated with IDeg, the mean and SD values for the SD of FBG in 30 patients over 7 consecutive days were calculated to derive the SD for the intra‐patient difference. The non‐inferiority margin was set as 20 mg/dL (1.1 mmol/L).…”

Section: Methodsmentioning

confidence: 99%

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Effects of insulin degludec and insulin glargine U300 on glycaemic stability in individuals with type 1 diabetes: A multicentre, randomized controlled crossover study

Miura

Sakaguchi

Otowa‐Suematsu

et al. 2020

Diabetes Obesity Metabolism

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To compare the effects of insulin degludec (IDeg) and insulin glargine U300 (IGlarU300) on glycaemic stability in subjects with type 1 diabetes. Materials and methods: In this multicentre, crossover trial, 46 individuals with type 1 diabetes and essentially undetectable circulating C-peptide were randomly assigned to either the IDeg-first/IGlarU300-second group or the IGlarU300-first/IDeg-second group, and were treated with the respective basal insulins for 4-week periods. Data were collected in the last week of each treatment period. The primary aim was to examine the potential non-inferiority of IDeg relative to IGlarU300 with regard to dayto-day variability, as evaluated by the standard deviation (SD) of fasting blood glucose (FBG) levels. Intra-day glycaemic variability and other variables were also determined by continuous glucose monitoring (CGM). Results: The SD of FBG for IDeg was non-inferior to that for IGlarU300. The mean of FBG, coefficient of variation of FBG, and various glycaemic variability indexes determined by CGM did not differ between the two insulins. Whereas the administered doses of the insulins also did not differ, the mean glycaemic value was lower for IDeg than IGlarU300; the time above the target range (>180 mg/dL [10.0 mmol/L]) and the time below the target range (<70 mg/dL [3.9 mmol/L]) were shorter and longer, respectively, for IDeg than IGlarU300. Conclusions: Our data suggest that IDeg and IGlarU300 have comparable glucosestabilizing effects in individuals with type 1 diabetes. However, the glucose-lowering effect of IDeg may be greater than that of IGlarU300 when titrated with a unit-based protocol. K E Y W O R D S basal insulin, clinical trial, continuous glucose monitoring, insulin therapy, type 1 diabetes 1 | INTRODUCTION Evidence suggests that, not only hyperglycaemia, but also the fluctuation and variability of glycaemia are related to the development of complications of diabetes. 1-8 Increased glycaemic variability is associated with a risk of hypoglycaemia, 9 which also contributes to the development of various health problems related to diabetes. 10,11 Minimization of glycaemic variability is thus an important issue in the choice of treatment for diabetes.

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The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia

Broeng-Mikkelgaard,

Brøsen,

Kristensen

et al. 2023

Front. Pharmacol.

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Type 1 diabetes is characterized by insulin deficiency, and treatment is to supply insulin mimicking the physiological endogenous insulin secretion. Since its discovery, insulin therapy has evolved, and since the 1990s, an increasing number of insulin analogs with various pharmacokinetic and pharmacodynamic profiles have become available. Despite the improvement of insulin therapy, hypoglycemia remains the main side effect and is a daily concern for many people with diabetes and their families. A proportion of people with type 1 diabetes are at increased risk of hypoglycemia and experience recurring episodes. When designing insulin trials, this group of people is most often excluded in order to reduce the risk of adverse study outcomes, even though it may be the group that may benefit the most from treatment with new insulins. The results of the phase III trials, therefore, underestimate the clinical impact and pharmacoeconomic effect of the implementation of new insulins in the broader type 1 diabetes population. This paper reviews the four insulin trials that include people at increased risk of hypoglycemia. In general, the studies confirm the results from phase III trials in terms of similar reduction and maintenance of HbA1c, as well as relative rate reductions of hypoglycemia. However, the absolute treatment differences in the reduction of hypoglycemia are even greater in the trials, including people at high risk of hypoglycemia. This emphasizes the importance of including people at high risk of hypoglycemia to assess the full clinical and pharmacoeconomic benefit of new insulins.

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Effects of Insulin Degludec and Insulin Glargine U300 on Day-to-Day Fasting Plasma Glucose Variability in Individuals with Type 1 Diabetes: A Multicenter, Randomized, Crossover Study (Kobe Best Basal Insulin Study 2)

Cited by 3 publications

References 17 publications

Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Effects of insulin degludec and insulin glargine U300 on glycaemic stability in individuals with type 1 diabetes: A multicentre, randomized controlled crossover study

The effect of insulin analogs in people with type 1 diabetes at increased risk of severe hypoglycemia

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