NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	01/12/2015
Target sample size	304
Countries of recruitment
Study type	Interventional
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 Outcome	HbA1c To determine the change in HbA1c from baseline after 24 weeks of imeglimin treatment
Secondary Outcome	HbA1c To assess the optimal dose of imeglimin in Japanese population

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 74age old
Gender	Both
Include criteria	Main 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 criteria	Main 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