Clinical trial NCT00567047: Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type-2 Diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: • Pharmacokinetic measures
timeFrame: throughout the study
Secondary outcomes:
measure: • Safety and tolerability measures
timeFrame: throughout the study
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novartis Investigator Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigator Site
state: Florida
city: Minneapolis
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Knoxville
country: United States
facility: Novartis Investigator Site
state: Tennessee
city: Richmond
country: United States
facility: Novartis Investigator Site
state: Virginia
city: Kiel
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: