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Sodium-glucose cotransporter 2 inhibitors improved time-in-range without increasing hypoglycemia in Japanese patients with type 1 diabetes: A retrospective, single-center, pilot study.

ABSTRACT: AIMS/INTRODUCTION:Studies have shown that sodium-glucose cotransporter 2 (SGLT2) inhibitors increased time-in-range (TIR; percentage of time glucose level remains between 3.9 and 10.0 mmol/L [70-180 mg/dL]) and decreased glycemic variability in patients with type 1 diabetes. The aim of this study was to investigate the effects of SGLT2 inhibitors on TIR, glycemic variability and glucose control in Japanese patients with type 1 diabetes in a real clinical setting. MATERIALS AND METHODS:We designed a single-arm, retrospective cohort study to analyze data from patients starting to use ipragliflozin or dapagliflozin and who used a sensor-based flash glucose monitoring system between February 2019 and August 2019. We measured TIR, time above range >180 mg/dL (percentage of time with glucose level of >180 mg/dL or >10.0 mmol/L), time below range <70 mg/dL (percentage of time with glucose level of <70 mg/dL or <3.9 mmol/L), mean glucose and standard deviation, and coefficient of variation for glycemic variability, and then compared the data before and after SGLT2 inhibitors treatments. RESULTS:We enrolled 15 patients in the study. The total dosages of basal insulin decreased significantly, but the total doses of bolus insulin did not change significantly. TIR increased significantly by approximately 11.6%; the time below range <70 mg/dL remained unchanged; and the mean glucose and standard deviation decreased significantly, whereas the coefficients of variation did not. CONCLUSIONS:SGLT2 inhibitors improved TIR and the mean glucose level and standard deviation without increasing the time below range <70 mg/dL in patients with type 1 diabetes.

SUBMITTER: Suzuki D

PROVIDER: S-EPMC7477508 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Sodium-glucose cotransporter 2 inhibitors improved time-in-range without increasing hypoglycemia in Japanese patients with type 1 diabetes: A retrospective, single-center, pilot study.

Suzuki Daisuke D Yamada Hodaka H Yoshida Masashi M Funazaki Shunsuke S Amamoto Misato M Morimoto Jun J Hara Kazuo K

Journal of diabetes investigation 20200327 5

<h4>Aims/introduction</h4>Studies have shown that sodium-glucose cotransporter 2 (SGLT2) inhibitors increased time-in-range (TIR; percentage of time glucose level remains between 3.9 and 10.0 mmol/L [70-180 mg/dL]) and decreased glycemic variability in patients with type 1 diabetes. The aim of this study was to investigate the effects of SGLT2 inhibitors on TIR, glycemic variability and glucose control in Japanese patients with type 1 diabetes in a real clinical setting.<h4>Materials and methods ...[more]

PMID: 32100964

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Project description:ObjectiveWhile the majority of current diabetes treatments focus on reducing blood glucose levels, hypoglycemia represents a significant risk associated with insulin treatment. Glucagon plays a major regulatory role in controlling hypoglycemia in vivo, but its short half-life and hyperglycemic effects prevent its therapeutic use for non-acute applications. The goal of this study was to identify a modified form of glucagon suitable for prophylactic treatment of hypoglycemia without increasing baseline blood glucose levels.Methodology/principal findingsThrough application of the XTEN technology, we report the construction of a glucagon fusion protein with an extended exposure profile (Gcg-XTEN). The in vivo half-life of the construct was tuned to support nightly dosing through design and testing in cynomolgus monkeys. Efficacy of the construct was assessed in beagle dogs using an insulin challenge to induce hypoglycemia. Dose ranging of Gcg-XTEN in fasted beagle dogs demonstrated that the compound was biologically active with a pharmacodynamic profile consistent with the designed half-life. Prophylactic administration of 0.6 nmol/kg Gcg-XTEN to dogs conferred resistance to a hypoglycemic challenge at 6 hours post-dose without affecting baseline blood glucose levels. Consistent with the designed pharmacokinetic profile, hypoglycemia resistance was not observed at 12 hours post-dose. Importantly, the solubility and stability of the glucagon peptide were also significantly improved by fusion to XTEN.Conclusions/significanceThe data show that Gcg-XTEN is effective in preventing hypoglycemia without the associated hyperglycemia expected for unmodified glucagon. While the plasma clearance of this Gcg-XTEN has been optimized for overnight dosing, specifically for the treatment of nocturnal hypoglycemia, constructs with significantly longer exposure profiles are feasible. Such constructs may have multiple applications such as allowing for more aggressive insulin treatment regimens, treating hypoglycemia due to insulin-secreting tumors, providing synergistic efficacy in combination therapies with long-acting GLP1 analogs, and as an appetite suppressant for treatment of obesity. The improved physical properties of the Gcg-XTEN molecule may also allow for novel delivery systems not currently possible with native glucagon.

Dataset Information

Sodium-glucose cotransporter 2 inhibitors improved time-in-range without increasing hypoglycemia in Japanese patients with type 1 diabetes: A retrospective, single-center, pilot study.

Publications

Sodium-glucose cotransporter 2 inhibitors improved time-in-range without increasing hypoglycemia in Japanese patients with type 1 diabetes: A retrospective, single-center, pilot study.

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