Diabetes Mellitus, Type 2Phase 3NCT00396227
Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone
A Phase 3 study testing vildagliptin and thiazolidinedione (TZD) in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone. 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 thiazolidinedione (TZD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,665 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2007
- 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
- Adult, Older adult
Who may be able to join
- Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
- Agreement to maintain the same dose of metformin from screening to the end of the study
- Age in the range of 18-80 years
- Body mass index (BMI) in the range of 22-40 kg/m2
- HbA1c in the range of 7.0 to 10%
- FPG <270 mg/dL (15 mmol/L)
Who cannot join
- A history of type 1 diabetes
- Liver disease
- Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1
- Other protocol-defined inclusion/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
Official title: A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin, thiazolidinedione (TZD)
- Keywords
- Type 2 diabetes, vildagliptin, hemoglobin A1c, metformin
- 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 Galvus
vildagliptin as add-on to metformin
thiazolidinedione (TZD)Drug
Also called Actos (pioglitazone), Avandia (rosiglitazone)
TZD add-on to metformin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vildagliptin 100mg + Met Receives: Drug: vildagliptin |
| TZD | Active comparator | TZD + metformin Receives: Drug: thiazolidinedione (TZD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HemoglobinA1c (HbA1c)
Measured: after 12 weeks of treatment
Secondary outcomes (3)
Change from baseline in body weight
Measured: after 12 weeks of treatment
Change from baseline in fasting plasma glucose (FPG)
Measured: after 12 weeks of treatment
Incidence of prespecified adverse events while on treatment with study drug
Measured: 12 week treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
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
- None (open label)
- Enrolment
- 2,665 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
- NCT00396227
- Sponsor's protocol ID
- CLAF237A23119
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Blonde L, Dagogo-Jack S, Banerji MA, Pratley RE, Marcellari A, Braceras R, Purkayastha D, Baron M. Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial--a primary care, type 2 diabetes study. Diabetes Obes Metab. 2009 Oct;11(10):978-86. doi: 10.1111/j.1463-1326.2009.01080.x. Epub 2009 Jul 13.
PubMed 19614942
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.
- ClinicalTrials.gov ID
- NCT00396227
- Acronym / sponsor ID
- CLAF237A23119
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, vildagliptin, hemoglobin A1c, metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,665 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- First posted
- 6 Nov 2006 (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 designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vildagliptinVildagliptin 100mg + Met |
| TZD | Active comparator | Drug: thiazolidinedione (TZD)TZD + metformin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
- Agreement to maintain the same dose of metformin from screening to the end of the study
- Age in the range of 18-80 years
- Body mass index (BMI) in the range of 22-40 kg/m2
- HbA1c in the range of 7.0 to 10%
Key exclusion criteria (4 listed)
- A history of type 1 diabetes
- Liver disease
- Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1
- 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 |
|---|---|---|
| vildagliptinAlso: Galvusvildagliptin as add-on to metformin | Drug | 1 |
| thiazolidinedione (TZD)Also: Actos (pioglitazone), Avandia (rosiglitazone)TZD add-on to metformin | Drug | TZD |
Primary outcome
Change from baseline in HemoglobinA1c (HbA1c)
Time frame: after 12 weeks of treatment
3 secondary outcomes
Change from baseline in body weight
Time frame: after 12 weeks of treatment
Change from baseline in fasting plasma glucose (FPG)
Time frame: after 12 weeks of treatment
Incidence of prespecified adverse events while on treatment with study drug
Time frame: 12 week treatment duration
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 18 Nov 2016.
- Results publication: PubMed 19614942Blonde L, Dagogo-Jack S, Banerji MA, Pratley RE, Marcellari A, Braceras R, Purkayastha D, Baron M. Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial--a primary care, type 2 diabetes study. Diabetes Obes Metab. 2009 Oct;11(10):978-86. doi: 10.1111/j.1463-1326.2009.01080.x. Epub 2009 Jul 13.
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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 thiazolidinedione (TZD) 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 6 inclusion and 4 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 18 Nov 2016. 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. 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 HemoglobinA1c (HbA1c) (time frame: after 12 weeks of treatment). 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 NCT00396227, 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 18 Nov 2016.