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

• Conditions: Type II Diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-004722-16-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-28
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• 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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified