Diabetes MellitusPhase 3NCT01431807
Long-term Study of SYR-472
A Phase 3 study testing SYR-472 in people with Diabetes Mellitus, run by Takeda at 41 sites in Japan.
Trial summary
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SYR-472
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 41 sitesJapan
- Study dates
- 1 Sep 2011to 1 Jun 2013
- 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
- The participant is an outpatient.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Diabetes Mellitus
Who cannot join
- The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Japan41 sites
Study site
Ageo-shi, Saitama
Study site
Akita, Akita
Study site
Chuo-ku, Tokyo
Study site
Eniwa-shi, Hokkaido
Study site
Fukuoka, Fukuoka
Study site
Fukuyama-shi, Hiroshima
Study site
Gihu-shi, Gihu
Study site
Hiroshima, Hiroshima
Study site
Ishikari-shi, Hokkaido
Study site
Kawaguchi-shi, Saitama
Study site
Kisarazu-shi, Chiba
Study site
Kobe, Hyōgo
Study site
Koganei-shi, Tokyo
Study site
Koriyama-shi, Fukushima
Study site
Koshigaya-shi, Saitama
Study site
Kuki-shi, Saitama
Study site
Kumamoto, Kumamoto
Study site
Kyoto, Kyoto
Study site
Meguro-ku, Tokyo
Study site
Minoh, Osaka
Study site
Mito, Ibaragi
Study site
Munakata-shi, Fukuoka
Study site
Nagano, Nagano
Study site
Nagawaki-shi, Nagasaki
Study site
Naka, Ibaragi
Study site
Nakagawa-gun, Hokkaido
Study site
Obihiro-shi, Hokkaido
Study site
Ōita, Oita Prefecture
Study site
Osaka, Osaka
Study site
Oyama-shi, Tochigi
Study site
Sagamihara-shi, Kanagawa
Study site
Saitama-shi, Saitama
Study site
Sakai-shi, Osaka
Study site
Sapporo, Hokkaido
Study site
Shibuya-ku, Tokyo
Study site
Suntou-gun, Shizuoka
Study site
Takamatsu, Kagawa-ken
Study site
Tama-shi, Tokyo
Study site
Tamana-shi, Kumamoto
Study site
Tiyoda-ku, Tokyo
Study site
Yokohama, Kanagawa
About this study
Official title: An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.
- Conditions
- Diabetes Mellitus
- Being tested
- SYR-472
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYR-472Drug
oral, for up to 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYR-472 group | Experimental | (long-term monotherapy or long-term combination therapy with anti-diabetic drugs) Receives: Drug: SYR-472 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
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 posted12 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion1 Jun 2013
- Study completion1 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Director, Study director, Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431807
- Sponsor's protocol ID
- SYR-472/OCT-001
- Other IDs
- JapicCTI-111592, U1111-1123-6415
- Status last verified
- Dec 2023
- First submitted
- 8 Sep 2011
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies
- ClinicalTrials.gov ID
- NCT01431807
- Acronym / sponsor ID
- SYR-472/OCT-001
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 12 Sep 2011 (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 evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYR-472 group | Experimental | Drug: SYR-472(long-term monotherapy or long-term combination therapy with anti-diabetic drugs) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participant is an outpatient.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Diabetes Mellitus
Key exclusion criteria (2 listed)
- The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
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 |
|---|---|---|
| SYR-472oral, for up to 52 weeks. | Drug | SYR-472 group |
Primary outcome
Adverse events
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 14 Dec 2023.
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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.
Senior Director study director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
41 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 SYR-472 in people with Diabetes Mellitus, run by Takeda at 41 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 2 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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?
Adverse events (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 14 Dec 2023.