Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

Novartis

Status and phase

Completed

Phase 1

Conditions

Type-2 Diabetes

Treatments

Drug: vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00567047

CLAF237A2115

Details and patient eligibility

About

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

Enrollment

96 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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