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

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ClinicalTrials.gov Identifier: NCT00633997
Recruitment Status : Terminated (After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.)
First Posted : March 12, 2008
Last Update Posted : May 24, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633997

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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00633997     History of Changes
Other Study ID Numbers: CLAF237A2224
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: April 2016

Keywords provided by Novartis:
Diabetes mellitus
type 2 diabetes

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