Diabetes Mellitus, Type 2Phase 3NCT00106340
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
A Phase 3 study testing vildagliptin, glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to… Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- vildagliptin, glimepiride and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,118 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2005to 20 May 2008
- 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 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On a stable dose of metformin as defined by the protocol
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
Who cannot join
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of significant diabetic complications
- Evidence of serious cardiovascular complications
- Laboratory value 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
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin, glimepiride, Metformin, Vildagliptin matching placebo, Glimepiride matching 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, Galvus
glimepirideDrug
MetforminDrug
Vildagliptin matching placeboDrug
Glimepiride matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: vildagliptin; Drug: Metformin; Drug: Glimepiride matching placebo |
| Glimepiride | Active comparator | Not described Receives: Drug: glimepiride; Drug: Metformin; Drug: Vildagliptin matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to HbA1c >8%
Measured: 2 year
Secondary outcomes (5)
Change from baseline in HbA1c at 5 years
Measured: 2 years (amended)
Adverse event profile after 5 years of treatment
Measured: 2 years (amended)
Coefficient of failure for HbA1c from week 24 to 5 years
Measured: 2 years (amended)
Change from baseline in fasting plasma glucose at 5 years
Measured: 2 years (amended)
Change from baseline in body weight at 5 years
Measured: 2 years (amended)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2008
- Study completion20 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106340
- Sponsor's protocol ID
- CLAF237A2308
- Status last verified
- Dec 2012
- First submitted
- 22 Mar 2005
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00106340
- Acronym / sponsor ID
- CLAF237A2308
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,118 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2008 (actual)
- Study completion
- 20 May 2008 (actual)
- First posted
- 23 Mar 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.
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: vildagliptin, Drug: Metformin, Drug: Glimepiride matching placebo |
| Glimepiride | Active comparator | Drug: glimepiride, Drug: Metformin, Drug: Vildagliptin matching placebo |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On a stable dose of metformin as defined by the protocol
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of significant diabetic complications
- Evidence of serious cardiovascular complications
- Laboratory value 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, Galvus | Drug | Vildagliptin |
| glimepiride | Drug | Glimepiride |
| Metformin | Drug | Glimepiride, Vildagliptin |
| Vildagliptin matching placebo | Drug | Glimepiride |
| Glimepiride matching placebo | Drug | Vildagliptin |
Primary outcome
Time to HbA1c >8%
Time frame: 2 year
5 secondary outcomes
Change from baseline in HbA1c at 5 years
Time frame: 2 years (amended)
Adverse event profile after 5 years of treatment
Time frame: 2 years (amended)
Coefficient of failure for HbA1c from week 24 to 5 years
Time frame: 2 years (amended)
Change from baseline in fasting plasma glucose at 5 years
Time frame: 2 years (amended)
Change from baseline in body weight at 5 years
Time frame: 2 years (amended)
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 17 Dec 2020.
- Results for CLAF237A2308 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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, glimepiride and Metformin 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 3 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 17 Dec 2020. 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?
Time to HbA1c >8% (time frame: 2 year). 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 17 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.