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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
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 September 16, 2014