NIPH Clinical Trials Search

Efficacy and safety of teneligliptin in patients with type 2 diabetes who responded insufficiently to dipeptidyl peptidase-4 (DPP-4) inhibitors

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	2013/06/01
Target sample size	20
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	teneligliptin

Outcome(s)

Primary Outcome	Change in Glycosylated hemoglobin(HbA1c) levels over 12 weeks,Change in DPP-4 activity
Secondary Outcome	Active Glucagon-like peptide-1 (GLP-1) concentration,Active Gastric inhibitory Polypeptide (GIP) concentration,Glucagon levels,Postprandial (1 and 2 hour) glucose levels,Fasting blood glucose levels,Insulin levels

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria	(1) Submission of written informed consent for participation in this study (2) Either gender (3) Age >=20 years on the date of submission of informed consent (4) Clinic visit (5) Previous treatment with any oral antidiabetic agent, other than a DPP-4 inhibitor, with a fixed dose and regimen of >=12 weeks and HbA1c levels (National Glycohemoglobin Standardization Program) in a rebound state of >=0.3% at week 0 despite an initial reduction in HbA1c levels >=0.5% by previous treatment with a DPP-4 inhibitor, other than teneligliptin (6) HbA1c levels of >=6.9% to <10.4%, as defined by the National Institutes of Diabetes and Digestive and Kidney Diseases (7) Difference in HbA1c levels <0.5% at the start date and 4 weeks before the start of administration
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) Excessive alcohol consumption : mean daily intake of pure alcohol >=60g (4) Pregnant women, women suspected of being pregnant, or lactating women (5) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason