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Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial

OBJECTIVE: To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6–17 years old) with type 1 diabetes. RESEARCH DESIGN AND METHODS: EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, pha...

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Autores principales: Danne, Thomas, Tamborlane, William V., Malievsky, Oleg A., Franco, Denise R., Kawamura, Tomoyuki, Demissie, Marek, Niemoeller, Elisabeth, Goyeau, Harmonie, Wardecki, Marek, Battelino, Tadej
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Diabetes Association 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305011/
https://www.ncbi.nlm.nih.gov/pubmed/32430458
http://dx.doi.org/10.2337/dc19-1926
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author Danne, Thomas
Tamborlane, William V.
Malievsky, Oleg A.
Franco, Denise R.
Kawamura, Tomoyuki
Demissie, Marek
Niemoeller, Elisabeth
Goyeau, Harmonie
Wardecki, Marek
Battelino, Tadej
author_facet Danne, Thomas
Tamborlane, William V.
Malievsky, Oleg A.
Franco, Denise R.
Kawamura, Tomoyuki
Demissie, Marek
Niemoeller, Elisabeth
Goyeau, Harmonie
Wardecki, Marek
Battelino, Tadej
author_sort Danne, Thomas
collection PubMed
description OBJECTIVE: To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6–17 years old) with type 1 diabetes. RESEARCH DESIGN AND METHODS: EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90–130 mg/dL (5.0–7.2 mmol/L), with continuation of prior prandial insulin. The primary end point was change in HbA(1c) from baseline to week 26. Other assessments included change in fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events. RESULTS: In 463 randomized participants (Gla-300, n = 233; Gla-100, n = 230), comparable least squares (LS) mean (SE) reductions in HbA(1c) were observed from baseline to week 26 (−0.40% [0.06%] for both groups), with LS mean between-group difference of 0.004% (95% CI −0.17 to 0.18), confirming noninferiority at the prespecified 0.3% (3.3 mmol/mol) margin. Mean FPG change from baseline to week 26 was also similar between groups. During the 6-month treatment period, incidence and event rates of severe or documented (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were similar between groups. Incidence of severe hypoglycemia was 6.0% with Gla-300 and 8.8% with Gla-100 (relative risk 0.68 [95% CI 0.35–1.30]). Incidence of any hyperglycemia with ketosis was 6.4% with Gla-300 and 11.8% with Gla-100. CONCLUSIONS: Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.
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spelling pubmed-73050112020-06-23 Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial Danne, Thomas Tamborlane, William V. Malievsky, Oleg A. Franco, Denise R. Kawamura, Tomoyuki Demissie, Marek Niemoeller, Elisabeth Goyeau, Harmonie Wardecki, Marek Battelino, Tadej Diabetes Care Emerging Therapies: Drugs and Regimens OBJECTIVE: To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6–17 years old) with type 1 diabetes. RESEARCH DESIGN AND METHODS: EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90–130 mg/dL (5.0–7.2 mmol/L), with continuation of prior prandial insulin. The primary end point was change in HbA(1c) from baseline to week 26. Other assessments included change in fasting plasma glucose (FPG), hypoglycemia, hyperglycemia with ketosis, and adverse events. RESULTS: In 463 randomized participants (Gla-300, n = 233; Gla-100, n = 230), comparable least squares (LS) mean (SE) reductions in HbA(1c) were observed from baseline to week 26 (−0.40% [0.06%] for both groups), with LS mean between-group difference of 0.004% (95% CI −0.17 to 0.18), confirming noninferiority at the prespecified 0.3% (3.3 mmol/mol) margin. Mean FPG change from baseline to week 26 was also similar between groups. During the 6-month treatment period, incidence and event rates of severe or documented (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were similar between groups. Incidence of severe hypoglycemia was 6.0% with Gla-300 and 8.8% with Gla-100 (relative risk 0.68 [95% CI 0.35–1.30]). Incidence of any hyperglycemia with ketosis was 6.4% with Gla-300 and 11.8% with Gla-100. CONCLUSIONS: Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population. American Diabetes Association 2020-07 2020-05-19 /pmc/articles/PMC7305011/ /pubmed/32430458 http://dx.doi.org/10.2337/dc19-1926 Text en © 2020 by the American Diabetes Association https://www.diabetesjournals.org/content/licenseReaders may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at https://www.diabetesjournals.org/content/license.
spellingShingle Emerging Therapies: Drugs and Regimens
Danne, Thomas
Tamborlane, William V.
Malievsky, Oleg A.
Franco, Denise R.
Kawamura, Tomoyuki
Demissie, Marek
Niemoeller, Elisabeth
Goyeau, Harmonie
Wardecki, Marek
Battelino, Tadej
Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
title Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
title_full Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
title_fullStr Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
title_full_unstemmed Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
title_short Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
title_sort efficacy and safety of insulin glargine 300 units/ml (gla-300) versus insulin glargine 100 units/ml (gla-100) in children and adolescents (6–17 years) with type 1 diabetes: results of the edition junior randomized controlled trial
topic Emerging Therapies: Drugs and Regimens
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305011/
https://www.ncbi.nlm.nih.gov/pubmed/32430458
http://dx.doi.org/10.2337/dc19-1926
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