Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment - Full Text View

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 1

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Vildagliptin	Drug: vildagliptin Other Name: LAF237

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

Locations

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
Germany
Novartis Investigator Site
Kiel, Germany

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis investigative site

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00567047 History of Changes
Other Study ID Numbers:	CLAF237A2115
Study First Received:	December 3, 2007
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013