Hiroshi Miura1, Kazuhiko Sakaguchi2, Natsu Otowa-Suematsu1, Tomoko Yamada1, Anna So1, Hisako Komada1, Yuko Okada1, Yushi Hirota1, Yoshikazu Tamori3, Wataru Ogawa1. 1. Division of Diabetes and Endocrinology, Kobe University Graduate School of Medicine, Kobe, Japan. 2. Division of General Internal Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. 3. Division of Creative Health Promotion, Department of Social/Community Medicine and Health Science, Kobe University Graduate School of Medicine, Kobe, Japan.
Abstract
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 day-to-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 glucose-stabilizing 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.
RCT Entities:
To compare the effects of insulin degludec (IDeg) and insulinglargine 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 day-to-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 glucose-stabilizing 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.
Authors: Florentino Carral San Laureano; Mariana Tomé Fernández-Ladreda; Ana Isabel Jiménez Millán; Concepción García Calzado; María Del Carmen Ayala Ortega Journal: J Investig Med Date: 2021-03-26 Impact factor: 2.895
Authors: Ulrik Pedersen-Bjergaard; Rikke M Agesen; Julie M B Brøsen; Amra C Alibegovic; Henrik U Andersen; Henning Beck-Nielsen; Peter Gustenhoff; Troels K Hansen; Christoffer Hedetoft; Tonny J Jensen; Claus B Juhl; Andreas K Jensen; Susanne S Lerche; Kirsten Nørgaard; Hans-Henrik Parving; Anne L Sørensen; Lise Tarnow; Birger Thorsteinsson Journal: Diabetes Obes Metab Date: 2021-11-02 Impact factor: 6.408