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:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00633997
First received: March 4, 2008
Last updated: September 4, 2012
Last verified: September 2012
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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 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 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 Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013