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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

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:
ClinicalTrials.gov Identifier:
NCT00633997
First Posted: March 12, 2008
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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
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

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) ]

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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00633997     History of Changes
Other Study ID Numbers: CLAF237A2224
First Submitted: March 4, 2008
First Posted: March 12, 2008
Last Update Posted: May 24, 2016
Last Verified: April 2016

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
Hypoglycemic Agents
Physiological Effects of Drugs