Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567047
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : March 25, 2009
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Brief Summary:
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.

Condition or disease Intervention/treatment Phase
Type-2 Diabetes Drug: vildagliptin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: vildagliptin
Other Name: LAF237

Primary Outcome Measures :
  1. • Pharmacokinetic measures [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. • Safety and tolerability measures [ Time Frame: throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567047

United States, Florida
Novartis Investigator Site
Miami, Florida, United States, 33136
Novartis Investigator Site
Orlando, Florida, United States, 32809
United States, Minnesota
Novartis Investigator Site
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Novartis Investigator Site
Knoxville, Tennessee, United States, 37920
United States, Virginia
Novartis Investigator Site
Richmond, Virginia, United States, 23298
Novartis Investigator Site
Kiel, Germany
Sponsors and Collaborators
Principal Investigator: Novartis Novartis investigative site

Responsible Party: Novartis Identifier: NCT00567047     History of Changes
Other Study ID Numbers: CLAF237A2115
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs