NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes
Date of first enrollment	22/05/2006
Target sample size	200
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 to endpoint on HbA1c at 12 weeks Secondary Outcomes: Change from baseline to endpoint on fasting plasma glucose at 12 weeks; Change from baseline to endpoint in HOMA B at 12 weeks; Change from baseline to endpoint in HOMA IR at 12 weeks; Change from baseline to endpoint on fasting lipids at 12 weeks; Adverse events profile after 12 weeks of treatment
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
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 and treated with a stable dose of sulfonylurea - Patients on diet and exercise who have not reached 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 as defined by the protocol - Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply.
Exclude criteria