Type 2 Diabetes MellitusPhase 3NCT01224366
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Vildagliptin in people with Type 2 Diabetes Mellitus, run by Novartis at 66 sites in 11 countries.
Trial summary
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy. 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
- 448 participants
- Where
- 66 sitesin 11 countries
- Study dates
- Sep 2010to Oct 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
- On a stable dose of insulin as defined by the protocol
- On a stable does of metformin (if applicable) as defined by the protocol
- Age 18 to 80 years
- HbA1c of 7.5 to 11.0%
- Body Mass Index (BMI) 22 to 40 kg/m2
Who cannot join
- Type 1 diabetes
- Short-acting or rapid-acting insulin
- Pregnancy or lactation
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular complications
- Laboratory value abnormalities as defined by the protocol
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
66 sites in 11 countries.
66 sites in 11 countries
Germany15 sites
Novartis Investigative Site
Aßlar
Novartis Investigative Site
Bensheim
Novartis Investigative Site
Berlin
Novartis Investigative Site
Einbeck
Novartis Investigative Site #1
Hamburg
Novartis Investigative Site #2
Hamburg
Novartis Investigative Site #3
Hamburg
Novartis Investigative Site #4
Hamburg
Novartis Investigative Site
Hanover
Novartis Investigative Site #1
Kassel
Novartis Investigative Site #2
Kassel
Novartis Investigative Site
München
Novartis Investigative Site
Saarlouis
Novartis Investigative Site
Schliemannstadt Neubukow
Novartis Investigative Site
Tübingen
India10 sites
Novartis Investigative Site
Indore
Novartis Investigative Site
Jaipur
Novartis Investigative Site
Karnāl
Novartis Investigative Site #2
Mumbai
Novartis Investigative Site #1
Mumbia
Novartis Investigative Site #1
Nagpur
Novartis Investigative Site #2
Nagpur
Novartis Investigative Site
Nashik
Novartis Investigative Site #1
Trivandrum
Novartis Investigative Site #2
Trivandrum
Slovakia8 sites
Novartis Investigative Site
Banská Bystrica
Novartis Investigative Site #1
Bratislava
Novartis Investigative Site #2
Bratislava
Novartis Investigative Site #3
Bratislava
Novartis Investigative Site #1
Košice
Novartis Investigative Site #2
Košice
Novartis Investigative Site
Prešov
Novartis Investigative Site
Štúrovo
Australia5 sites
Novartis Investigative Site
Box Hill
Novartis Investigative Site
Heidelberg Heights
Novartis Investigative Site
Parkville
Novartis Investigative Site #1
Wollongong
Novartis Investigative Site #2
Wollongong
Belgium5 sites
Novartis Investigative Site
Bonheiden
Novartis Investigative Site
Edegem
Novartis Investigative Site
Genk
Novartis Investigative Site
La Louvière
Novartis Investigative Site
Ronse
Guatemala5 sites
Novartis Investigative Site #1
Guatemala City
Novartis Investigative Site #2
Guatemala City
Novartis Investigative Site #3
Guatemala City
Novartis Investigative Site #4
Guatemala City
Novartis Investigative Site #5
Guatemala City
Hungary5 sites
Novartis Investigative Site #1
Budapest
Novartis Investigative Site #2
Budapest
Novartis Investigative Site
Dunaújváros
Novartis Investigative Site
Nyíregyháza
Novartis Investigative Site
Szeged
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
Czechia3 sites
Novartis Investigative Site #1
Ostrava
Novartis Investigative Site #2
Ostrava
Novartis Investigative Site #3
Ostrava
United Kingdom3 sites
Novartis Investigative Site
Carmarthen
Novartis Investigative Site #1
Glasgow
Novartis Investigative Site #2
Glasgow
Hong Kong2 sites
Novartis Investigative Site #1
Hong Kong
Novartis Investigative Site #2
Hong Kong
About this study
Official title: A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Placebo
- Keywords
- Add-on to insulin
- 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 | Experimental | Not described Receives: Drug: Vildagliptin |
| Placebo | 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 (5)
HbA1c reduction in subpopulation treated with insulin and with metformin
Measured: 24 weeks
HbA1c reduction in subpopulation treated with insulin and without metformin
Measured: 24 weeks
Reduction in FPG (overall and subpopulations)
Measured: 24 weeks
Responder rates (overall and subpopulations)
Measured: 24 weeks
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
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 posted20 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224366
- Sponsor's protocol ID
- CLAF237A23135
- Status last verified
- Feb 2017
- First submitted
- 18 Oct 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151.
PubMed 23961326
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 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01224366
- Acronym / sponsor ID
- CLAF237A23135
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Add-on to insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Oct 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.
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
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 |
| Placebo | 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 (6 listed)
- Confirmed diagnosis of T2DM
- On a stable dose of insulin as defined by the protocol
- On a stable does of metformin (if applicable) as defined by the protocol
- Age 18 to 80 years
- HbA1c of 7.5 to 11.0%
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Short-acting or rapid-acting insulin
- Pregnancy or lactation
- Evidence of serious diabetic complications
- Evidence of serious cardiovascular complications
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 |
| Placebo | Drug | Placebo |
Primary outcome
HbA1c reduction
Time frame: 24 weeks
5 secondary outcomes
HbA1c reduction in subpopulation treated with insulin and with metformin
Time frame: 24 weeks
HbA1c reduction in subpopulation treated with insulin and without metformin
Time frame: 24 weeks
Reduction in FPG (overall and subpopulations)
Time frame: 24 weeks
Responder rates (overall and subpopulations)
Time frame: 24 weeks
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
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 23961326Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151.
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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 chair
Novartis Pharmaceuticals
66 sites in 11 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 66 sites in 11 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 6 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 66 sites in Germany, India, Slovakia, Australia, Belgium and 6 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 NCT01224366, 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.