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. )

First Received: March 4, 2008 Last Updated: June 16, 2009 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00633997

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 I Phase II

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin

U.S. FDA Resources

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
1: Experimental Healthy volunteers	Drug: Vildagliptin 50 mg orally twice daily for 10 days (last dose morning of day 10)
2: Experimental 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 ( Novartis )
Study ID Numbers:	CLAF237A2224
Study First Received:	March 4, 2008
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00633997 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Diabetes mellitus
type 2 diabetes
vildagliptin
pharmacokinetics

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Vildagliptin
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009