A multi-center, randomized, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as add-on therapy to metformin in patients with type 2 diabetes

ovartis Pharma Services AG0 个研究点目标入组 2,500 人开始时间: 2009年1月16日最近更新: 2012年7月24日

适应症

试验速览

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•Male, non-fertile female or female of childbearing potential using a medically approved birth control method
•Age in the range of 18-78 years inclusive at visit 1.
•Patients with T2DM treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1.
•Agreement to maintain the same dose of metformin throughout the study.
•HbA1c of = 7.0 and = 9.5% at visit 1.
•Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
•after conception and until the termination of gestation, confirmed by a positive hCG
•laboratory test (> 5 mIU/mL).
•2. FPG = 270 mg/dL (= 15.0 mmol/L).
•3. Any of the following significant laboratory abnormalities:
•Clinically significant TSH outside of normal range at visit 1
•Clinically significant renal dysfunction as indicated by serum creatinine levels = 1.5
•mg/dL (132 µmol/L) for males and = 1.4 mg/dL (123 µmol/L) for females at visit 1,
•or a history of abnormal creatinine clearance
•Elevated fasting triglycerides > 500 mg/dL at visit 1, confirmed by a repeat measure
•within 3 working days
•Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper
•limit of normal (ULN) at visit 1, confirmed by repeat measure within 3 working days
•Total bilirubin > 2 x ULN and/or direct bilirubin > ULN at visit 1, confirmed by
•repeat measure within 3 working days
•Positive Hepatitis B surface antigen (HbsAg)
•Positive Hepatitis C antibody test (anti-HCV)
•Clinically significant laboratory abnormalities at the opinion of the investigator
•4. Congestive heart failure requiring pharmacological treatment.
•For detailed exclusion criteria, please refer to the full protocol.

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