- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00567047
Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment
March 24, 2009 updated by: Novartis
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
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kiel, Germany
- Novartis Investigator Site
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Florida
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Miami, Florida, United States, 33136
- Novartis Investigator Site
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Orlando, Florida, United States, 32809
- Novartis Investigator Site
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Novartis Investigator Site
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Tennessee
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Knoxville, Tennessee, United States, 37920
- Novartis Investigator Site
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Virginia
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Richmond, Virginia, United States, 23298
- Novartis Investigator Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Vildagliptin
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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• Pharmacokinetic measures
Time Frame: throughout the study
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throughout the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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• Safety and tolerability measures
Time Frame: throughout the study
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throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
December 3, 2007
First Submitted That Met QC Criteria
December 3, 2007
First Posted (Estimate)
December 4, 2007
Study Record Updates
Last Update Posted (Estimate)
March 25, 2009
Last Update Submitted That Met QC Criteria
March 24, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLAF237A2115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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