JRCT ID: jRCT2080220326
Registered date:29/11/2006
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | Type 2 Diabetes |
Date of first enrollment | 29/11/2006 |
Target sample size | 150 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : Vildagliptin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral |
Outcome(s)
Primary Outcome | Primary Adverse events profile after 52 weeks of treatment Secondary Outcomes: Change from baseline to endpoint on HbA1c at 52 weeks, Change from baseline to endpoint on fasting plasma glucose at 52 weeks, Change from baseline to endpoint in HOMA B at 52 weeks; Change from baseline to endpoint in HOMA IR at 52 weeks; Change from baseline to endpoint in body weight at 52 weeks |
---|---|
Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
---|---|
Age maximum | Not applicable |
Gender | |
Include criteria | Inclusion Criteria: - Diagnosis of type 2 diabetes - Patients who have completed study CLAF237A1303 - Outpatients Exclusion Criteria: - Patients who prematurely discontinued Study CLAF237A1303 Other protocol-defined inclusion/exclusion criteria may apply |
Exclude criteria |
Related Information
Primary Sponsor | Novartis Pharma K.K. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-060331 |
Contact
Public contact | |
Name | |
Address | 0120-003-293 |
Telephone | |
Affiliation | Novartis Pharma KK |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |