Type 2 DiabetesPhase 3NCT01159249
Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 24 sites in Japan.
Trial summary
This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 24 sitesJapan
- Study dates
- Jun 2010to Jan 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
- Age in the 20 years or over inclusive
- HbA1c in the range of ≥ 6.5 to ≤ 10%
Who cannot join
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic complications
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
Novartis Investigative Site
Chikushino-shi, Fukuoka, 818-0036
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0084
Novartis Investigative Site
Fukuoka, 807-0857
Novartis Investigative Site
Fukuoka, 816-0094
Novartis Investigative Site
Fukuoka, 819-0168
Novartis Investigative Site
Hachiōji, Tokyo, 192-0046
Novartis Investigative Site
Hannou, Saitama, 357-0024
Novartis Investigative Site
Hiki-Gun, Saitama, 355-0328
Novartis Investigative Site
Hunabashi, Chiba, 274-0805
Novartis Investigative Site
Itoshima-shi, Fukuoka, 819-1102
Novartis Investigative Site
Izumisano, Osaka, 598-0048
Novartis Investigative Site
Katsushika-ku, Tokyo, 125-0041
Novartis Investigative Site
Kawaguchi, Saitama, 332-0012
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852
Novartis Investigative Site
Kawasaki, Kanagawa, 212-0024
Novartis Investigative Site
Kobe, Hyōgo, 658-0064
Novartis Investigative Site
Kōriyama, Fukushima, 963-8851
Novartis Investigative Site
Koshigaya, Saitama, 343-0826
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Tokorozawa, Saitama, 359-1161
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Yokohama, Kanagawa, 221-0065
Novartis Investigative Site
Yokohama, Kanagawa, 221-0077
About this study
Official title: A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes
This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.
- Conditions
- Type 2 Diabetes
- Being tested
- Vildagliptin
- Keywords
- Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety
- 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
| Study group | Role | What they receive |
|---|---|---|
| Open Met add-on vildagliptin | Other | Not described Receives: Drug: Vildagliptin |
| Open TZD add-on vildagliptin | Other | Not described Receives: Drug: Vildagliptin |
| Open α-GI add-on vildagliptin | Other | Not described Receives: Drug: Vildagliptin |
| Glinides add-on vildagliptin | Other | Not described Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure AEs, vital signs, laboratory evaluations
Measured: 52 weeks
Secondary outcomes (5)
HBA1c
Measured: 52 weeks
Fasting Plasma Glucose
Measured: 52 weeks
Fasting Insulin
Measured: 52 weeks
Fasting C-peptide
Measured: 52 weeks
HOMA-B
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals Corporation, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159249
- Sponsor's protocol ID
- CLAF237A1308
- Status last verified
- May 2012
- First submitted
- 7 Jul 2010
- 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
- A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01159249
- Acronym / sponsor ID
- CLAF237A1308
- Conditions
- Type 2 Diabetes
- Keywords
- Vildagliptin, Type 2 Diabetes, HbA1c, Fasting Plasma Glucose, Long-Term Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Jul 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 is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open Met add-on vildagliptin | Other | Drug: Vildagliptin |
| Open TZD add-on vildagliptin | Other | Drug: Vildagliptin |
| Open α-GI add-on vildagliptin | Other | Drug: Vildagliptin |
| Glinides add-on vildagliptin | Other | Drug: Vildagliptin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
- Age in the 20 years or over inclusive
- HbA1c in the range of ≥ 6.5 to ≤ 10%
Key exclusion criteria (3 listed)
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic 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 | Glinides add-on vildagliptin, Open Met add-on vildagliptin, Open TZD add-on vildagliptin, Open α-GI add-on vildagliptin |
Primary outcome
Measure AEs, vital signs, laboratory evaluations
Time frame: 52 weeks
5 secondary outcomes
HBA1c
Time frame: 52 weeks
Fasting Plasma Glucose
Time frame: 52 weeks
Fasting Insulin
Time frame: 52 weeks
Fasting C-peptide
Time frame: 52 weeks
HOMA-B
Time frame: 52 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 17 Dec 2020.
- Results for CLAF237A1308 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
Novartis Pharmaceuticals Corporation study director
Novartis Pharmaceuticals
24 sites 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 in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 24 sites in Japan.
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 3 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 24 sites in Japan. 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?
Measure AEs, vital signs, laboratory evaluations (time frame: 52 weeks). 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.