NCT00567047

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.5 years

First QC Date

December 3, 2007

Last Update Submit

March 24, 2009

Conditions

Type-2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • • Pharmacokinetic measures

    throughout the study

Secondary Outcomes (1)

  • • Safety and tolerability measures

    throughout the study

Study Arms (1)

1

EXPERIMENTAL

Vildagliptin

Drug: vildagliptin

Interventions

vildagliptinDRUG
Also known as: LAF237
1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigator Site

Miami, Florida, 33136, United States

Location

Novartis Investigator Site

Orlando, Florida, 32809, United States

Location

Novartis Investigator Site

Minneapolis, Minnesota, 55404, United States

Location

Novartis Investigator Site

Knoxville, Tennessee, 37920, United States

Location

Novartis Investigator Site

Richmond, Virginia, 23298, United States

Location

Novartis Investigator Site

Kiel, Germany

Location

MeSH Terms

Interventions

Vildagliptin1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis

    Novartis investigative site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 4, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

US(5)DE(1)