Diabetes Mellitus, Type 2Phase 3NCT00351585
A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis.
Trial summary
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Sep 2005
- 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 30 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
- Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
- BMI in the range 22-45
- Blood glucose criteria must be met
Who cannot join
- Pregnancy or lactation
- Type 1 diabetes or diabetes resulting from pancreatic injury
- Cardiovascular complications as defined by the protocol
- Significant diabetic complications as defined by the protocol
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin
- Keywords
- Vildagliptin, Type 2 diabetes, Insulin secretion, Beta cell
- 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.
Change from baseline in maximal insulin secretory capacity at 12 weeks
Durability of this effect after a 2-week washout
Secondary outcomes (3)
Change from baseline in beta-cell sensitivity to glucose at 12 weeks
Durability of this effect after a 2-week washout
Chance from baseline in glucagon secretion at 12 weeks
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 startJul 2004
- Primary completionSep 2005
- Study completionSep 2005
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.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David D'Alessio, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351585
- Sponsor's protocol ID
- CLAF237A2344
- Status last verified
- May 2012
- First submitted
- 11 Jul 2006
- Last updated
- 7 May 2012
- Results posted
- No
Publications
D'Alessio DA, Denney AM, Hermiller LM, Prigeon RL, Martin JM, Tharp WG, Saylan ML, He Y, Dunning BE, Foley JE, Pratley RE. Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2009 Jan;94(1):81-8. doi: 10.1210/jc.2008-1135. Epub 2008 Oct 28.
PubMed 18957505
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, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00351585
- Acronym / sponsor ID
- CLAF237A2344
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vildagliptin, Type 2 diabetes, Insulin secretion, Beta cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (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.
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes for at least 6 months
- Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
- BMI in the range 22-45
- Blood glucose criteria must be met
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Type 1 diabetes or diabetes resulting from pancreatic injury
- Cardiovascular complications as defined by the protocol
- Significant diabetic complications 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
Change from baseline in maximal insulin secretory capacity at 12 weeks
Durability of this effect after a 2-week washout
3 secondary outcomes
Change from baseline in beta-cell sensitivity to glucose at 12 weeks
Durability of this effect after a 2-week washout
Chance from baseline in glucagon secretion at 12 weeks
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 18957505D'Alessio DA, Denney AM, Hermiller LM, Prigeon RL, Martin JM, Tharp WG, Saylan ML, He Y, Dunning BE, Foley JE, Pratley RE. Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2009 Jan;94(1):81-8. doi: 10.1210/jc.2008-1135. Epub 2008 Oct 28.
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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.
David D'Alessio, MD principal investigator
University of Cincinnati
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.
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 4 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.
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?
Change from baseline in maximal insulin secretory capacity at 12 weeks. The study lists 2 primary outcomes in all. 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 NCT00351585, 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; AzTrials last refreshed its copy on 6 Nov 2026.