NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080223032

Registered date:01/12/2015

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 Diabetes Mellitus
Date of first enrollment01/12/2015
Target sample size304
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : PXL008 INN of investigational material : Imeglimin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary OutcomeHbA1c To determine the change in HbA1c from baseline after 24 weeks of imeglimin treatment
Secondary OutcomeHbA1c To assess the optimal dose of imeglimin in Japanese population

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 74age old
GenderBoth
Include criteriaMain inclusion criteria: 1) Patients with type 2 diabetes mellitus, diagnosed for at least 3 months 2) Body mass index (BMI) >= 18.5 3) HbA1c >= 7.0% and < 10.0%
Exclude criteriaMain exclusion criteria: 1) Patients with type 1 diabetes mellitus 2) History of ketoacidosis or lactic acidosis 3) Acute clinically significant cardiovascular event within 6 months (myocardial infarction, stroke) 4) Uncontrolled high blood pressure 5) Impairment of hepatic function

Related Information

Contact

Public contact
Name
Address ClinicalTrialInformation@cmic.co.jp
Telephone
E-mail
Affiliation CMIC Co.,Ltd.
Scientific contact
Name
Address http://www.poxel.com/contact/overview-contact.php
Telephone
E-mail
Affiliation POXEL S.A.