Diabetes MellitusPhase 3NCT01433393
Double-blind Comparative Study of TAK-875
A Phase 3 study testing TAK-875 in people with Diabetes Mellitus, run by Takeda at 19 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 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?
- TAK-875
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 19 sitesJapan
- Study dates
- Start not givento Sep 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
- 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.
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 sub-investigator.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Study site
Chiyoda-ku, Tokyo
Study site
Fukuoka-shi Nishi-ku, Fukuoka
Study site
Kashihara-shi, Nara
Study site
Kashiwara-shi, Osaka
Study site
Kasuga-shi, Fukuoka
Study site
Kisarazu-shi, Chiba
Study site
Kyoto-shi Fushimi-ku, Kyoto
Study site
Matsuyama, Ehime
Study site
Nagasaki, Nagasaki
Study site
Naka, Ibaragi
Study site
Osaka-shi Tsurumi-ku, Osaka
Study site
Ōta-ku, Tokyo
Study site
Sakai-shi Nishi-ku, Osaka
Study site
Shimotsuke-shi, Tochigi
Study site
Shinjuku-ku, Tokyo
Study site
tabashi City, Tokyo
Study site
Takamatsu, Kagawa-ken
Study site
Toshima-ku, Tokyo
Study site
Tsuchiura-shi, Ibaragi
About this study
The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.
- Conditions
- Diabetes Mellitus
- Being tested
- TAK-875, Placebo
- Keywords
- Drug Therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-875Drug
TAK-875Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TAK-875 25 mg | Experimental | Not described Receives: Drug: TAK-875 |
| TAK-875 50 mg | Experimental | Not described Receives: Drug: TAK-875 |
| 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Primary completionSep 2012
- Study completionSep 2012
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
- Intervention model
- Parallel groups
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433393
- Sponsor's protocol ID
- TAK-875/CCT-003
- Other IDs
- U1111-1124-1518, JapicCTI-111604
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Comparative Study of TAK-875
- ClinicalTrials.gov ID
- NCT01433393
- Acronym / sponsor ID
- TAK-875/CCT-003
- Conditions
- Diabetes Mellitus
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 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.
The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.
Study design
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAK-875 25 mg | Experimental | Drug: TAK-875 |
| TAK-875 50 mg | Experimental | Drug: TAK-875 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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.
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 sub-investigator.
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 |
|---|---|---|
| TAK-875 | Drug | TAK-875 25 mg |
| TAK-875 | Drug | TAK-875 50 mg |
| Placebo | Drug | Placebo |
Primary outcome
HbA1c
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 9 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 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 TAK-875 in people with Diabetes Mellitus, run by Takeda at 19 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 2 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. 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. 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 9 Nov 2012.