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Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial.
Inoue, Megumi; Lorenz, Martin; Muto, Hideya; Wesch, Roland; Hashimoto, Yasuhiro.
Afiliação
  • Inoue M; SOUSEIKAI PS Clinic, Fukuoka, Japan.
  • Lorenz M; Research & Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
  • Muto H; Research & Development, Sanofi K.K., Tokyo, Japan.
  • Wesch R; Research & Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
  • Hashimoto Y; Research & Development, Sanofi K.K., Tokyo, Japan.
Diabetes Obes Metab ; 21(8): 2001-2005, 2019 08.
Article em En | MEDLINE | ID: mdl-31050109
This report describes novel clinical data assessing the pharmacodynamics of insulin glargine/lixisenatide (iGlarLixi) compared with placebo and insulin glargine alone, to determine pharmacokinetics of lixisenatide, and to assess safety of iGlarLixi in Japanese people with type 2 diabetes mellitus (T2DM). In a single-centre, open-label, randomized, placebo-controlled cross-over study, participants received subcutaneous iGlarLixi 5 U/5 µg and 10 U/10 µg, placebo, and 5 U insulin glargine. The primary endpoint was area under the postprandial plasma glucose (PPG) curve (AUC0-2h ). A total of 20 participants completed all study periods. iGlarLixi 5 U/5 µg and 10 U/10 µg reduced mean PPG dose-dependently compared with placebo and insulin glargine 5 U. Both combinations significantly reduced PPG-AUC0-2h dose-dependently compared with placebo (least squares mean difference -7.48 mmol h/L for 5 U/5 µg, -10.75 mmol h/L for 10 U/10 µg; P < 0.0001). iGlarLixi 5 U/5 µg reduced PPG-AUC0-2h significantly compared with insulin glargine 5 U (-0.76 mmol h/L; P < 0.0001). No symptomatic hypoglycaemia occurred during the study. iGlarLixi single subcutaneous injections significantly and dose-dependently reduced PPG compared to placebo or insulin glargine in Japanese participants with T2DM. iGlarLixi was safe and well tolerated, and would be expected to provide the 24-hour plasma glucose-lowering effects of insulin glargine and the postprandial antihyperglycaemic effects of lixisenatide.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Peptídeos / Período Pós-Prandial / Diabetes Mellitus Tipo 2 / Insulina Glargina / Hipoglicemiantes Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Peptídeos / Período Pós-Prandial / Diabetes Mellitus Tipo 2 / Insulina Glargina / Hipoglicemiantes Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Ano de publicação: 2019 Tipo de documento: Article