Diabetes Mellitus, Type 2Phase 3NCT00099944
Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
A Phase 3 study testing vildagliptin and Glimepiride in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 1 site in United States.
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 safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- vildagliptin and Glimepiride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 515 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood glucose criteria must be met
- Previously treated with a sulfonylurea for at least 3 months
- Body mass index (BMI) in the range 22-45
Who cannot join
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious cardiovascular complications
- Evidence of serious diabetic complications
- Laboratory value abnormalities as defined by the protocol
- Known sensitivity to glimepiride
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
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 safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin, Glimepiride, LAF237 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
GlimepirideDrug
Glimepiride 4 mg qd
LAF237 placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| LAF237 50 mg qd + glimepiride 4 mg qd | Experimental | LAF237 50 mg qd + glimepiride 4 mg qd Receives: Drug: vildagliptin; Drug: Glimepiride |
| LAF237 50 mg bid + glimepiride 4 mg qd | Experimental | LAF237 50 mg bid + glimepiride 4 mg qd Receives: Drug: vildagliptin; Drug: Glimepiride |
| LAF237 placebo + glimepiride 4 mg qd | Placebo comparator | LAF237 placebo + glimepiride 4 mg qd Receives: Drug: Glimepiride; Drug: LAF237 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c after 24 weeks
Secondary outcomes (5)
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2004 (estimated)
- Study startMay 2004
- Primary completionOct 2005
- Study completionOct 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.
- 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
- 515 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
- NCT00099944
- Sponsor's protocol ID
- CLAF237A2305
- Status last verified
- May 2012
- First submitted
- 21 Dec 2004
- Last updated
- 7 May 2012
- Results posted
- No
Publications
Garber AJ, Foley JE, Banerji MA, Ebeling P, Gudbjornsdottir S, Camisasca RP, Couturier A, Baron MA. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008 Nov;10(11):1047-56. doi: 10.1111/j.1463-1326.2008.00859.x. Epub 2008 Feb 18.
PubMed 18284434
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 in Combination With Glimepiride in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00099944
- Acronym / sponsor ID
- CLAF237A2305
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Dec 2004 (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 safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAF237 50 mg qd + glimepiride 4 mg qd | Experimental | Drug: vildagliptin, Drug: GlimepirideLAF237 50 mg qd + glimepiride 4 mg qd |
| LAF237 50 mg bid + glimepiride 4 mg qd | Experimental | Drug: vildagliptin, Drug: GlimepirideLAF237 50 mg bid + glimepiride 4 mg qd |
| LAF237 placebo + glimepiride 4 mg qd | Placebo comparator | Drug: Glimepiride, Drug: LAF237 placeboLAF237 placebo + glimepiride 4 mg qd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blood glucose criteria must be met
- Previously treated with a sulfonylurea for at least 3 months
- Body mass index (BMI) in the range 22-45
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious cardiovascular complications
- Evidence of serious diabetic 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 |
|---|---|---|
| vildagliptin | Drug | LAF237 50 mg bid + glimepiride 4 mg qd, LAF237 50 mg qd + glimepiride 4 mg qd |
| GlimepirideGlimepiride 4 mg qd | Drug | LAF237 50 mg bid + glimepiride 4 mg qd, LAF237 50 mg qd + glimepiride 4 mg qd, LAF237 placebo + glimepiride 4 mg qd |
| LAF237 placebo | Drug | LAF237 placebo + glimepiride 4 mg qd |
Primary outcome
Change from baseline in HbA1c after 24 weeks
5 secondary outcomes
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
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 18284434Garber AJ, Foley JE, Banerji MA, Ebeling P, Gudbjornsdottir S, Camisasca RP, Couturier A, Baron MA. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008 Nov;10(11):1047-56. doi: 10.1111/j.1463-1326.2008.00859.x. Epub 2008 Feb 18.
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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
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 vildagliptin and Glimepiride in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals 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 3 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 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 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. 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 after 24 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 NCT00099944, 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.