JRCT ID: jRCT2080220283
Registered date:27/07/2006
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 Diabetes |
Date of first enrollment | 27/07/2006 |
Target sample size | 236 |
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 Outcomes: Change from baseline on HbA1c at 12 weeks Secondary Outcomes: Change from baseline on fasting plasma glucose at 12 weeks; Change from baseline on HOMA-veta at 12 weeks; Change from baseline on HOMA-R at 12 weeks; Change from baseline in body weight at 12 weeks; Change from baseline on fasting lipids at 12 weeks |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both Inclusion Criteria: - Diagnosis of type 2 diabetes - Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels - Outpatients Exclusion Criteria: - Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes - Significant cardiovascular complications - Significant diabetic complications Other protocol-defined inclusion/exclusion criteria may apply |
Exclude criteria |
Related Information
Primary Sponsor | Novartis Pharma K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-060288 |
Contact
Public contact | |
Name | |
Address | 0120-003-293 |
Telephone | |
Affiliation | Novartis Pharma KK |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |