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

March 4, 2008
September 4, 2012
February 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10
Complete list of historical versions of study NCT00633997 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: Vildagliptin
    50 mg orally twice daily for 10 days (last dose morning of day 10)
    Other Name: LAF237 Galvus
  • Drug: Vildagliptin
  • Experimental: 1
    Healthy volunteers
    Intervention: Drug: Vildagliptin
  • Experimental: 2
    Type II diabetics
    Intervention: Drug: Vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
Not Provided
December 2008   (final data collection date for primary outcome measure)

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

Both
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00633997
CLAF237A2224
No
Novartis
Novartis
Not Provided
Principal Investigator: Novartis Novartis investigator site
Novartis
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP