JRCT ID: jRCT2080221679
Registered date:21/12/2011
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus |
Date of first enrollment | 21/12/2011 |
Target sample size | 136 |
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 : Twice daily, oral control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Twice daily, oral |
Outcome(s)
Primary Outcome | HbA1c |
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Secondary Outcome | HbA1c, Fasting plasma glucose, Safety |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 74age old |
Gender | Both |
Include criteria | - Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy - HbA1c in the range of 7.0-10.0% - Body mass index in the range 20-35 kg/m2 |
Exclude criteria | - Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes - Significant heart diseases |
Related Information
Primary Sponsor | Novartis Pharma K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-111721 |
Contact
Public contact | |
Name | |
Address | 0120-003-293 |
Telephone | |
Affiliation | Novartis Pharma K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |