Study design of a phase ii clinical trial to assess the efficacy and safety of eperisone in japanese type 2 diabetes patients with risk and non-risk alleles of CDKAL1

Kourin Sakakida; Fan Yan Wei; Takafumi Senokuchi; Seiya Shimoda; Tatsuyuki Kakuma; Eiichi Araki; Kazuhito Tomizawa

Study design of a phase ii clinical trial to assess the efficacy and safety of eperisone in japanese type 2 diabetes patients with risk and non-risk alleles of CDKAL1

Kourin Sakakida, Fan Yan Wei, Takafumi Senokuchi, Seiya Shimoda, Tatsuyuki Kakuma, Eiichi Araki, Kazuhito Tomizawa

IDAC - Division of Aging Science

Research output: Contribution to journal › Article › peer-review

Abstract

Genetic variation in Cdk5 Regulatory Associated Protein 1-Like 1 (CDKAL1) is associated with the development of type 2 diabetes (T2D). Dysfunction of CDKAL1 impairs the translation of proinsulin, which leads to glucose intolerance. Eperisone, an antispasmodic agent, has been shown to ameliorate glucose intolerance in Cdkal1- deficient mice. We have launched a phase II clinical study to investigate the potential anti-diabetic effect of eperisone in T2D patients carrying risk or non-risk alleles of CDKAL1. The primary endpoint is the change of hemoglobin A1c (HbA1c) levels. We also examined whether the efficacy of eperisone in T2D patients is associated with CDKAL1 activity.

Original language	English
Pages (from-to)	423-426
Number of pages	4
Journal	Acta Medica Okayama
Volume	72
Issue number	4
Publication status	Published - 2018

Keywords

Diabetes
Glucose
Insulin secretion
Single nucleotide polymorphism

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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title = "Study design of a phase ii clinical trial to assess the efficacy and safety of eperisone in japanese type 2 diabetes patients with risk and non-risk alleles of CDKAL1",

abstract = "Genetic variation in Cdk5 Regulatory Associated Protein 1-Like 1 (CDKAL1) is associated with the development of type 2 diabetes (T2D). Dysfunction of CDKAL1 impairs the translation of proinsulin, which leads to glucose intolerance. Eperisone, an antispasmodic agent, has been shown to ameliorate glucose intolerance in Cdkal1- deficient mice. We have launched a phase II clinical study to investigate the potential anti-diabetic effect of eperisone in T2D patients carrying risk or non-risk alleles of CDKAL1. The primary endpoint is the change of hemoglobin A1c (HbA1c) levels. We also examined whether the efficacy of eperisone in T2D patients is associated with CDKAL1 activity.",

keywords = "Diabetes, Glucose, Insulin secretion, Single nucleotide polymorphism",

author = "Kourin Sakakida and Wei, {Fan Yan} and Takafumi Senokuchi and Seiya Shimoda and Tatsuyuki Kakuma and Eiichi Araki and Kazuhito Tomizawa",

note = "Funding Information: Acknowledgments　This work is supported by a Grant-in-Aid for Research on the Development of New Drugs from the Japan Agency for Medical Research and Development (AMED) (16ak0101023h0003). Publisher Copyright: {\textcopyright}2018 by Okayama University Medical School.",

year = "2018",

language = "English",

volume = "72",

pages = "423--426",

journal = "Acta Medica Okayama",

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T1 - Study design of a phase ii clinical trial to assess the efficacy and safety of eperisone in japanese type 2 diabetes patients with risk and non-risk alleles of CDKAL1

AU - Sakakida, Kourin

AU - Wei, Fan Yan

AU - Senokuchi, Takafumi

AU - Shimoda, Seiya

AU - Kakuma, Tatsuyuki

AU - Araki, Eiichi

AU - Tomizawa, Kazuhito

N1 - Funding Information: Acknowledgments　This work is supported by a Grant-in-Aid for Research on the Development of New Drugs from the Japan Agency for Medical Research and Development (AMED) (16ak0101023h0003). Publisher Copyright: ©2018 by Okayama University Medical School.

PY - 2018

Y1 - 2018

N2 - Genetic variation in Cdk5 Regulatory Associated Protein 1-Like 1 (CDKAL1) is associated with the development of type 2 diabetes (T2D). Dysfunction of CDKAL1 impairs the translation of proinsulin, which leads to glucose intolerance. Eperisone, an antispasmodic agent, has been shown to ameliorate glucose intolerance in Cdkal1- deficient mice. We have launched a phase II clinical study to investigate the potential anti-diabetic effect of eperisone in T2D patients carrying risk or non-risk alleles of CDKAL1. The primary endpoint is the change of hemoglobin A1c (HbA1c) levels. We also examined whether the efficacy of eperisone in T2D patients is associated with CDKAL1 activity.

AB - Genetic variation in Cdk5 Regulatory Associated Protein 1-Like 1 (CDKAL1) is associated with the development of type 2 diabetes (T2D). Dysfunction of CDKAL1 impairs the translation of proinsulin, which leads to glucose intolerance. Eperisone, an antispasmodic agent, has been shown to ameliorate glucose intolerance in Cdkal1- deficient mice. We have launched a phase II clinical study to investigate the potential anti-diabetic effect of eperisone in T2D patients carrying risk or non-risk alleles of CDKAL1. The primary endpoint is the change of hemoglobin A1c (HbA1c) levels. We also examined whether the efficacy of eperisone in T2D patients is associated with CDKAL1 activity.

KW - Diabetes

KW - Glucose

KW - Insulin secretion

KW - Single nucleotide polymorphism

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JO - Acta Medica Okayama

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Study design of a phase ii clinical trial to assess the efficacy and safety of eperisone in japanese type 2 diabetes patients with risk and non-risk alleles of CDKAL1

Abstract

Keywords

UN SDGs

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