Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

Completed · Phase 1

Conditions studied: Type-2 Diabetes

In brief

This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.

Key facts

Study ID

NCT00567047

Run by

Novartis

People needed

96

Starts

2007-07-01

Last updated by the study team

2009-03-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Pregnant or lactating female.
• A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma))
• Subjects that have been enrolled in previous vildagliptin studies or other DPP
• 4 inhibitor studies within six months
• History of renal transplant or immunosuppressant therapy
• Acute infections which may affect blood glucose control or other medical condition that may interfere with the interpretation of efficacy and safety data during the study
• Any pre-existing or history of diabetic ulcer
• Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke
• Any of the following electrocardiogram (ECG) abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree atrioventricular (AV) block (Mobitz 1 and 2), third degree AV block, prolonged QTc (>500 ms)
• Malignancy including leukemia and lymphoma within the last 5 years.
• Liver disease such as cirrhosis or positive hepatitis B and C.
• Any alcohol related hepatic disease.
• Patients undergoing any method of dialysis
• Use of some concomitant medications
• Significant laboratory abnormalities as specified in the protocol
• History of active substance abuse (including alcohol) within the past 2 years.
• Smokers (i.e., 10 or more cigarettes per day)
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigator Site — Miami, Florida, United States
• Novartis Investigator Site — Orlando, Florida, United States
• Novartis Investigator Site — Minneapolis, Minnesota, United States
• Novartis Investigator Site — Knoxville, Tennessee, United States
• Novartis Investigator Site — Richmond, Virginia, United States
• Novartis Investigator Site — Kiel, Germany

Full record on ClinicalTrials.gov

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