Diabetes Mellitus, Type 2Phase 3NCT00101712
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
A Phase 3 study testing vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- vildagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2004to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
- Diagnosis of type 2 diabetes for at least 8 weeks
Who cannot join
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular complications
- Significant laboratory abnormalities as defined by the protocol
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin, Vildagliptin Placebo
- Keywords
- type 2 diabetes, 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.
vildagliptinDrug
Also called LAF237
Vildagliptin PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: vildagliptin |
| Placebo | Placebo comparator | Not described Receives: Drug: Vildagliptin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at 52 weeks
Secondary outcomes (5)
Adverse event profile after 52 weeks of treatment
Patients with HbA1c <6.5% at 12 weeks
Patients with HbA1c <6.5% at 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Coefficient of failure for HbA1c between 24 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101712
- Sponsor's protocol ID
- CLAF237A2307
- Status last verified
- May 2012
- First submitted
- 12 Jan 2005
- Last updated
- 7 May 2012
- Results posted
- No
Publications
Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Jauffret S, Foley JE. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia*. Diabetes Obes Metab. 2008 Aug;10(8):675-82. doi: 10.1111/j.1463-1326.2008.00850.x. Epub 2007 Nov 22.
PubMed 18248490Mari A, Scherbaum WA, Nilsson PM, Lalanne G, Schweizer A, Dunning BE, Jauffret S, Foley JE. Characterization of the influence of vildagliptin on model-assessed -cell function in patients with type 2 diabetes and mild hyperglycemia. J Clin Endocrinol Metab. 2008 Jan;93(1):103-9. doi: 10.1210/jc.2007-1639. Epub 2007 Oct 9.
PubMed 17925336
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
- Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
- ClinicalTrials.gov ID
- NCT00101712
- Acronym / sponsor ID
- CLAF237A2307
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 13 Jan 2005 (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 is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: vildagliptin |
| Placebo | Placebo comparator | Drug: Vildagliptin Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
- Diagnosis of type 2 diabetes for at least 8 weeks
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular complications
- Significant laboratory abnormalities as defined by the protocol
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 | Drug | Vildagliptin |
| Vildagliptin Placebo | Drug | Placebo |
Primary outcome
Change from baseline in HbA1c at 52 weeks
5 secondary outcomes
Adverse event profile after 52 weeks of treatment
Patients with HbA1c <6.5% at 12 weeks
Patients with HbA1c <6.5% at 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Coefficient of failure for HbA1c between 24 weeks and 52 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 18248490Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Jauffret S, Foley JE. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia*. Diabetes Obes Metab. 2008 Aug;10(8):675-82. doi: 10.1111/j.1463-1326.2008.00850.x. Epub 2007 Nov 22.
- Derived from this study: PubMed 17925336Mari A, Scherbaum WA, Nilsson PM, Lalanne G, Schweizer A, Dunning BE, Jauffret S, Foley JE. Characterization of the influence of vildagliptin on model-assessed -cell function in patients with type 2 diabetes and mild hyperglycemia. J Clin Endocrinol Metab. 2008 Jan;93(1):103-9. doi: 10.1210/jc.2007-1639. Epub 2007 Oct 9.
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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 Pharmaceuticals 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 4 inclusion and 6 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 2 sites in Germany, Switzerland. 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. Some participants in this study may receive a placebo. 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 HbA1c at 52 weeks. 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 NCT00101712, which also lists 2 linked publications.
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.