Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

Type-2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567047
• Other study ID #: CLAF237A2115
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2007
• Last updated: March 24, 2009
• Start date: July 2007

Study information

• Verified date: March 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type-2 Diabetes

Intervention

Drug:
• vildagliptin

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Kiel
United States	Novartis Investigator Site	Knoxville	Tennessee
United States	Novartis Investigator Site	Miami	Florida
United States	Novartis Investigator Site	Minneapolis	Minnesota
United States	Novartis Investigator Site	Orlando	Florida
United States	Novartis Investigator Site	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Pharmacokinetic measures		throughout the study	No
Secondary	• Safety and tolerability measures		throughout the study	No