JRCT ID: jRCT2080221882
Registered date:10/08/2012
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
| Date of first enrollment | 10/08/2012 |
| Target sample size | 120 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | investigational material(s) Generic name etc : AY4166 INN of investigational material : nateglinide Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral |
Outcome(s)
| Primary Outcome | Safety adverse events, laboratory evaluations, vital signs, 12-lead electrocardiograms |
|---|---|
| Secondary Outcome | Efficacy HbA1c (NGSP) |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients with type 2 diabetes inadequately controlled with sitagliptin monotherapy - HbA1c (NGSP) in the range of ≥ 6.9 to < 8.9 % - postprandial plasma glucose 1 hour or 2hour after meal in the range of ≥ 200 mg/dL |
| Exclude criteria | - Type 1 diabetes mellitus - Patients with significant complications |
Related Information
| Primary Sponsor | Ajinomoto Pharmaceuticals Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | JapicCTI-121927 |
Contact
| Public contact | |
| Name | |
| Address | contact_ ajis@ajinomoto.com |
| Telephone | |
| Affiliation | Ajinomoto Pharmaceuticals Co., Ltd |
| Scientific contact | |
| Name | |
| Address | |
| Telephone | |
| Affiliation | |