Long-term safety study of vildagliptin in patients with type 2 diabetes

Authors
Category Primary study
Registry of TrialsJapicCTI
Year 2006
INTERVENTION: Intervention name : Vildagliptin Dosage And administration of the intervention : Oral CONDITION: Type 2 Diabetes PRIMARY OUTCOME: Primary Outcomes: 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; INCLUSION 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 as defined by the protocol ‐ Significant diabetic complications as defined by the protocol Other protocol‐defined inclusion/exclusion criteria may apply
Epistemonikos ID: d0acc4ab1bf58c0ca4c074d36a6301bc2091fab7
First added on: Jul 02, 2024