UMIN ID: UMIN000014298
Registered date:18/06/2014
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 | |
| 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 |
Related Information
| Primary Sponsor | Naka Kinen Clinic |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Vascular Disease Research Foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kensuke Ofuchi |
| Address | 745-5,Nakadai,Naka-city,Ibaraki,311-0113,Japan Japan |
| Telephone | 029-353-2800 |
| k-ofuchi@kensei-kai.com | |
| Affiliation | Naka Kinen Clinic Clinical Laboratory |
| scientific contact | |
| Name | Takeshi Osonoi |
| Address | 745-5,Nakadai,Naka-city,Ibaraki,311-0113,Japan Japan |
| Telephone | 029-353-2800 |
| t-osonoi@kensei-kai.com | |
| Affiliation | Naka Kinen Clinic Director |