Diabetes Mellitus, Type 2Phase 3NCT00351507
A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Feb 2006
- Phase
- Phase 3
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes for at least 6 months
- Blood glucose criteria must be met
- BMI in the range 22-40
Who cannot join
- History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Use of thiazolidinediones or need for insulin within 3 months prior to screening
- Significant concomitant diseases or complications of diabetes
- High fasting triglycerides as defined by the protocol
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes
This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin
- Keywords
- Vildagliptin, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on gastric emptying
Secondary outcomes (3)
Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startMay 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Vella, MD, Principal investigator, Mayo Clinic & Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351507
- Sponsor's protocol ID
- CLAF237A2343
- Status last verified
- May 2012
- First submitted
- 11 Jul 2006
- Last updated
- 7 May 2012
- Results posted
- No
Publications
Dalla Man C, Bock G, Giesler PD, Serra DB, Ligueros Saylan M, Foley JE, Camilleri M, Toffolo G, Cobelli C, Rizza RA, Vella A. Dipeptidyl peptidase-4 inhibition by vildagliptin and the effect on insulin secretion and action in response to meal ingestion in type 2 diabetes. Diabetes Care. 2009 Jan;32(1):14-8. doi: 10.2337/dc08-1512. Epub 2008 Oct 17.
PubMed 18931099
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00351507
- Acronym / sponsor ID
- CLAF237A2343
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vildagliptin, Type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 13 Jul 2006 (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 was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes for at least 6 months
- Blood glucose criteria must be met
- BMI in the range 22-40
Key exclusion criteria (5 listed)
- History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Use of thiazolidinediones or need for insulin within 3 months prior to screening
- Significant concomitant diseases or complications of diabetes
- High fasting triglycerides as defined by the protocol
- 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 |
|---|---|---|
| Vildagliptin | Drug | – |
Primary outcome
Effect on gastric emptying
3 secondary outcomes
Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
- Derived from this study: PubMed 18931099Dalla Man C, Bock G, Giesler PD, Serra DB, Ligueros Saylan M, Foley JE, Camilleri M, Toffolo G, Cobelli C, Rizza RA, Vella A. Dipeptidyl peptidase-4 inhibition by vildagliptin and the effect on insulin secretion and action in response to meal ingestion in type 2 diabetes. Diabetes Care. 2009 Jan;32(1):14-8. doi: 10.2337/dc08-1512. Epub 2008 Oct 17.
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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.
Adrian Vella, MD principal investigator
Mayo Clinic & Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals 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: finished, as of the sponsor's last update on 7 May 2012. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect on gastric emptying. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00351507, which also lists 1 linked publication.
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 7 May 2012.