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Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment
This study is currently recruiting participants.
Verified by Novartis, June 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00567047
  Purpose

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


Condition Intervention Phase
Type-2 Diabetes
Drug: vildagliptin
Phase I

MedlinePlus related topics: Diabetes
Drug Information available for: Vildagliptin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment
Official Title: An Open-Label, Parallel-Group Study to Determine the Single and Multiple Dose Pharmacokinetics of Vildagliptin and Its Metabolites in Mild, Moderate or Severe Renal Impaired Patients Compared to Age, Sex and Weight-Matched Healthy Volunteers Following Daily Doses of 50 mg Vildagliptin for 14 Days

Further study details as provided by Novartis:

Primary Outcome Measures:
  • • Pharmacokinetic measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Safety and tolerability measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: July 2007
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
1: Experimental
Vildagliptin
Drug: vildagliptin

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (general):

  • Men and women (age 18 to 85 years)
  • Participants must be nonfertile or using a medically approved birth control method. Additional information regarding this requirement available at screening
  • Body mass index (BMI) ≤42 kg/m2 (inclusive)

Inclusion Criteria (for renal insufficient patients):

  • Patients with mild, moderate, or severe kidney impairment. Please consult with participating physicians regarding the definitions of these levels of severity.
  • Patients with diabetes must be treated with standard anti-diabetic therapy (diet and exercise, stable dose of sulfonylurea, insulin, or metiglinides) and agree to continue for the study duration

Inclusion Criteria (for healthy subjects):

  • No current significant medical conditions as determined by history and physical.
  • Serum creatinine with a calculated creatinine clearance (CrCl) of >80 ml/min.
  • Matched to renal impaired patients in the study by age (±5 years), sex and weight (±10% BMI)
  • Vital signs guided by the following ranges:

oral body temperature between 35.0-37.2 °C systolic blood pressure, 100-140 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 45-90 bpm

Exclusion criteria:

  • 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567047

Contacts
Contact: NOVARTIS 862-778-8300

Locations
United States, Florida
Novartis Investigator Site Recruiting
Miami, Florida, United States, 33136
Contact: NOVARTIS     862-778-8300        
Novartis Investigator Site Recruiting
Orlando, Florida, United States, 32809
Contact: NOVARTIS     862-778-8300        
United States, Minnesota
Novartis Investigator Site Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: NOVARTIS     862-778-8300        
United States, Tennessee
Novartis Investigator Site Recruiting
Knoxville, Tennessee, United States, 37920
Contact: NOVARTIS     862-778-8300        
United States, Virginia
Novartis Investigator Site Recruiting
Richmond, Virginia, United States, 23298
Contact: NOVARTIS     862-778-8300        
Germany
Novartis Investigator Site Recruiting
Kiel, Germany
Contact: NOVARTIS     +41 61 324 1111        
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigative site
  More Information

Responsible Party: Novartis ( Novartis )
Study ID Numbers: CLAF237A2115
Study First Received: December 3, 2007
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00567047  
Health Authority: United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Body Weight
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009