Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00952991
The Effects of LAF237 on Gastric Function in Type 2 Diabetes
A Phase 3 study testing LAF237 = vildagliptin in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Mayo Clinic at 1 site in United States.
Trial summary
Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- LAF237 = vildagliptin
- How many people
- 18 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Cross Over, Placebo Controlled, Multiple-dose Study to Evaluate the Effects of LAF237 on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes.
Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- LAF237 = vildagliptin
- 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.
LAF237 = vildagliptinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying
Gastric accommodation
Satiety
Gastrointestinal Symptoms
Secondary outcomes (5)
Meal Appearance Rate
Glucose Disappearance
Endogenous Glucose Production
Insulin Secretion
Glucagon Secretion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (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.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 18 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952991
- Sponsor's protocol ID
- 1721-04
- Status last verified
- Mar 2011
- First submitted
- 4 Aug 2009
- Last updated
- 23 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Cross Over, Placebo Controlled, Multiple-dose Study to Evaluate the Effects of LAF237 on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00952991
- Acronym / sponsor ID
- 1721-04
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- May 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 6 Aug 2009 (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.
Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LAF237 = vildagliptin | Drug | – |
Primary outcome
Gastric Emptying
Gastric accommodation
Satiety
Gastrointestinal Symptoms
5 secondary outcomes
Meal Appearance Rate
Glucose Disappearance
Endogenous Glucose Production
Insulin Secretion
Glucagon Secretion
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 23 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 LAF237 = vildagliptin in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Mayo Clinic 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 1 inclusion and 0 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 23 Mar 2011. 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?
Gastric Emptying. The study lists 4 primary outcomes in all. 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 23 Mar 2011.