NIPH Clinical Trials Search

The effects of teneligliptin on cardiac function and endothelial function in patients with type 2 diabetes

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	2013/10/28
Target sample size	40
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	teneligliptin

Outcome(s)

Primary Outcome	Change in Glycosylated hemoglobin (HbA1c) levels over 24 weeks
Secondary Outcome	Echocardiography, Endothelial function, Biomarker

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria	1)Patients who continued diet and exercise therapy more than 12 weeks before day1. Exercise therapy is not essential if it is prohibited because of the complication 2)HbA1c levels of 6.9%<= to <10.4%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases 3)Difference in HbA1c levels <0.5% at the start date and 4 weeks before the start of administration 4)Insufficient in an effect except DPP-4 inhibitor
Exclude criteria	1)Type-1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions such as Cushing's syndrome and acromegaly 2)Application of contraindications contained in the package insert 3)Heart failure (NYHA grade 3-4) 4)Patients prone to QT prolongation 5)Excessive alcohol consumption 6)Pregnant women, women suspected of being pregnant, or lactating women 7)History of myocardial infarction 8)The medication in the treatment of diabetes drugs not be used with insurance 9)Under administration of GLP-1 agonists