JRCT ID: jRCT2080221153
Registered date:08/07/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 Diabetes |
Date of first enrollment | 08/07/2010 |
Target sample size | 216 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : LAF237 INN of investigational material : Vildagliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral |
Outcome(s)
Primary Outcome | Safety |
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Secondary Outcome | HbA1c, fasting plasma glucose, fasting insulin, fasting c-peptide, HOMA-B |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or alpha-GI, or glinides monotherapy - Age in the 20 years or over inclusive - HbA1c in the range of >= 6.5 to =< 10% |
Exclude criteria | - Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes - Significant heart diseases - Significant diabetic complications |
Related Information
Primary Sponsor | Novartis Pharma K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101188 |
Contact
Public contact | |
Name | |
Address | 0120-003-293 |
Telephone | |
Affiliation | Novartis Pharma K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |