Diabetes Mellitus, Type 2Phase 1/2NCT00633997
Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes
A Phase 1/2 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigator Site
Baltimore, Maryland, 21225
About this 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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin
- Keywords
- Diabetes mellitus, type 2 diabetes, vildagliptin, pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called LAF237 Galvus
50 mg orally twice daily for 10 days (last dose morning of day 10)
VildagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy volunteers Receives: Drug: Vildagliptin |
| 2 | Experimental | Type II diabetics Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin concentration of vildagliptin and its two metabolites, LAY151 and LAF237-O-Glucuronide, compared to the plasma concentration on Day 10
Measured: Baseline (Day -1) to End of Study (Day 17 +/- 2 days)
Secondary outcomes (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
Measured: Baseline (Day -1) to End of study (Day 17 +/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
Why it stopped: After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633997
- Sponsor's protocol ID
- CLAF237A2224
- Status last verified
- Apr 2016
- First submitted
- 4 Mar 2008
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00633997
- Acronym / sponsor ID
- CLAF237A2224
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus, type 2 diabetes, vildagliptin, pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VildagliptinHealthy volunteers |
| 2 | Experimental | Drug: VildagliptinType II diabetics |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VildagliptinAlso: LAF237 Galvus50 mg orally twice daily for 10 days (last dose morning of day 10) | Drug | 1 |
| Vildagliptin | Drug | 2 |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study was stopped early (reason given: After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CLAF237A2224 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Novartis investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: After analysis of the existing data, it was determined that additional skin biopsy samples would not be required to determine study outcome.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.