Type 2 Diabetes MellitusPhase 3VildagliptinNCT01233622
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
A Phase 3 study testing Vildagliptin in people with Type 2 Diabetes Mellitus, run by Novartis at 55 sites in 9 countries.
Trial summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 55 sitesin 9 countries
- Study dates
- Oct 2010to Nov 2011
- 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
- Confirmed diagnosis of T2DM by standard criteria.
- Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
- Age: ≥18 to ≤ 80 years
- HbA1c of ≥ 7.5 and ≤ 11.0%
- Body Mass Index (BMI) ≥22 to ≤45 kg/m2
Who cannot join
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
55 sites in 9 countries.
55 sites in 9 countries
Mexico15 sites
Novartis Investigative Site #1
Aguascalientes
Novartis Investigative Site #2
Aguascalientes
Novartis Investigative Site #3
Aguascalientes
Novartis Investigative Site #1
Durango
Novartis Investigative Site #2
Durango
Novartis Investigative Site #3
Durango
Novartis Investigative Site #1
Guadalajara
Novartis Investigative Site #2
Guadalajara
Novartis Investigative Site #3
Guadalajara
Novartis Investigative Site #4
Guadalajara
Novartis Investigative Site #5
Guadalajara
Novartis Investigative Site
México
Novartis Investigative Site #1
Pachuca
Novartis Investigative Site #2
Pachuca
Novartis Investigative Site #3
Pachuca
Germany8 sites
Novartis Investigative Site
Anderbeck
Novartis Investigative Site #1
Berlin
Novartis Investigative Site #2
Berlin
Novartis Investigative Site #3
Berlin
Novartis Investigative Site #4
Berlin
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Hildesheim
Novartis Investigative Site
Sangerhausen
Italy8 sites
Novartis Investigative Site
Bergamo
Novartis Investigative Site
Cosenza
Novartis Investigative Site
Milan
Novartis Investigative Site
Padova
Novartis Investigative Site
Pisa
Novartis Investigative Site #1
Roma
Novartis Investigative Site #2
Roma
Novartis Investigative Site
Torino
Romania5 sites
Novartis Investigative Site
Alba Iulia
Novartis Investigative Site
Bucharest
Novartis Investigative Site #1
Oradea
Novartis Investigative Site #2
Oradea
Novartis Investigative Site
Târgu Mureş
South Korea5 sites
Novartis Investigative Site
Bundang
Novartis Investigative Site #1
Seoul
Novartis Investigative Site #2
Seoul
Novartis Investigative Site #3
Seoul
Novartis Investigative Site
Suwon
Australia4 sites
Novartis Investigative Site
Box Hill
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Parkville
Novartis Investigative Site
St Leonards
Taiwan4 sites
Novartis Investigative Site
Changhua
Novartis Investigative Site
Taichung
Novartis Investigative Site
Taipei
Novartis Investigative Site
Yongkang District
Hungary3 sites
Novartis Investigative Site
Budapest
Novartis Investigative Site
Érd
Novartis Investigative Site
Törökbálint
Philippines3 sites
Novartis Investigative Site
Manila
Novartis Investigative Site #1
Quezon City
Novartis Investigative Site #2
Quezon City
About this study
Official title: A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin (metformin + glimepiride) | Experimental | Not described Receives: Drug: Vildagliptin |
| Placebo (metformin + glimepiride) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Reduction
Measured: 24 weeks
Secondary outcomes (3)
FPG reduction
Measured: 24 weeks
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
Measured: 24 weeks
Responder Rate
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
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 Type 2 Diabetes MellitusStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 317 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
- NCT01233622
- Sponsor's protocol ID
- CLAF237A23152
- Other IDs
- EudraCT 2010-021097-11
- Acronym
- Vildagliptin
- Status last verified
- Feb 2017
- First submitted
- 1 Nov 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2.
PubMed 24199686
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
- A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01233622
- Acronym / sponsor ID
- Vildagliptin / CLAF237A23152
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Nov 2010 (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 will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin (metformin + glimepiride) | Experimental | Drug: Vildagliptin |
| Placebo (metformin + glimepiride) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of T2DM by standard criteria.
- Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
- Age: ≥18 to ≤ 80 years
- HbA1c of ≥ 7.5 and ≤ 11.0%
- Body Mass Index (BMI) ≥22 to ≤45 kg/m2
Key exclusion criteria (5 listed)
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Acute infections which may affect blood glucose control within 4 weeks prior to screening 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 | Vildagliptin (metformin + glimepiride) |
| Placebo | Drug | Placebo (metformin + glimepiride) |
Primary outcome
HbA1c Reduction
Time frame: 24 weeks
3 secondary outcomes
FPG reduction
Time frame: 24 weeks
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
Time frame: 24 weeks
Responder Rate
Time frame: 24 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 23 Feb 2017.
- Results publication: PubMed 24199686Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2.
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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
55 sites in 9 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 Type 2 Diabetes Mellitus, run by Novartis at 55 sites in 9 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 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 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 55 sites in Mexico, Germany, Italy, Romania, South Korea and 4 more countries. 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?
HbA1c Reduction (time frame: 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 NCT01233622, 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.