Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes

This study has been terminated.
(After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00633997
First received: March 4, 2008
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

This study will look at the skin accumulation of vildagliptin and its two major metabolites, LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10 days in both healthy volunteers and patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Multiple Dose Study to Assess the Steady-state Skin Concentrations and Pharmacokinetics of Vildagliptin 50 mg BID for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10 [ Time Frame: Baseline (Day -1) to End of Study (Day 17 +/- 2 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 10 day's treatment with vildagliptin 50 mg orally twice daily on hematology, blood chemistry and physical exams in healthy volunteers and patients with type 2 diabetes [ Time Frame: Baseline (Day -1) to End of study (Day 17 +/- 2 days) ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: February 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Healthy volunteers
Drug: Vildagliptin
50 mg orally twice daily for 10 days (last dose morning of day 10)
Other Name: LAF237 Galvus
Experimental: 2
Type II diabetics
Drug: Vildagliptin

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers and patients with type 2 diabetes
  • Non-smoking, Caucasian and African American, male and female (postmenopausal, surgically sterile or using double-barrier method of contraception) subjects between 30 and 65 years of age (inclusive)
  • Type 2 diabetics on metformin and/or sufonylurea

Exclusion Criteria:

  • History of type 1 diabetes or insulin use
  • History of coagulation abnormalities
  • History of abnormal heart conditions
  • Pregnancy or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633997

Locations
United States, Maryland
Novartis Investigator Site
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00633997     History of Changes
Other Study ID Numbers: CLAF237A2224
Study First Received: March 4, 2008
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Diabetes mellitus
type 2 diabetes
vildagliptin
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014