Diabetes Mellitus, Type 2Phase 3NCT00380445
Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 2 sites in 2 countries.
Trial summary
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus. 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
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2006to Apr 2007
- 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
- Adult, Older adult
Who may be able to join
- Must be able to complete a 3-week wash-out of current anti-diabetic medication
- Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
- Must discontinue beta-blockers and lipid lowering drugs
- Blood glucose criteria must be met
- BMI in the range 30-35
Who cannot join
- History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Need for insulin within 3 months or patients on thiazolidinediones
- Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
- Significant concomitant disease or complications of diabetes
- Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
- High tryglycerides as defined by the protocol
- Smokers who cannot abstain from smoking during the treatment periods
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.
- 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.
To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
Secondary outcomes (1)
To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionApr 2007
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
- Crossover
- Masking
- Double blind
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380445
- Sponsor's protocol ID
- CLAF237A2379
- Status last verified
- Feb 2017
- First submitted
- 22 Sep 2006
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Boschmann M, Engeli S, Dobberstein K, Budziarek P, Strauss A, Boehnke J, Sweep FC, Luft FC, He Y, Foley JE, Jordan J. Dipeptidyl-peptidase-IV inhibition augments postprandial lipid mobilization and oxidation in type 2 diabetic patients. J Clin Endocrinol Metab. 2009 Mar;94(3):846-52. doi: 10.1210/jc.2008-1400. Epub 2008 Dec 16.
PubMed 19088168
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00380445
- Acronym / sponsor ID
- CLAF237A2379
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vildagliptin, Type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 26 Sep 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.
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be able to complete a 3-week wash-out of current anti-diabetic medication
- Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
- Must discontinue beta-blockers and lipid lowering drugs
- Blood glucose criteria must be met
- BMI in the range 30-35
Key exclusion criteria (7 listed)
- History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Need for insulin within 3 months or patients on thiazolidinediones
- Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
- Significant concomitant disease or complications of diabetes
- Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
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
To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
1 secondary outcome
To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)
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 Feb 2017.
- Results publication: PubMed 19088168Boschmann M, Engeli S, Dobberstein K, Budziarek P, Strauss A, Boehnke J, Sweep FC, Luft FC, He Y, Foley JE, Jordan J. Dipeptidyl-peptidase-IV inhibition augments postprandial lipid mobilization and oxidation in type 2 diabetic patients. J Clin Endocrinol Metab. 2009 Mar;94(3):846-52. doi: 10.1210/jc.2008-1400. Epub 2008 Dec 16.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: 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 at 2 sites in 2 countries.
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 5 inclusion and 7 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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?
To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes. 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 NCT00380445, 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 23 Feb 2017.