Diabetic PatientsPhase 3NCT01585792
Double Blind Comparative Study of TAK-875
A Phase 3 study testing TAK-875 and Glimepiride in people with Diabetic Patients, run by Takeda at 2 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
- Diabetic Patients
- What is being tested?
- TAK-875 and Glimepiride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesJapan
- Study dates
- May 2012to Dec 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 subinvestigator.
Trial locations and contacts
2 sites in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.
- Conditions
- Diabetic Patients
- Being tested
- TAK-875, Glimepiride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-875Drug
TAK-875Drug
GlimepirideDrug
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 |
| Glimepiride | Active comparator | Not described Receives: Drug: Glimepiride |
| 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.
Blood glucose
Blood glucose
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PatientsStudies 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
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585792
- Sponsor's protocol ID
- TAK-875/CPH-030
- Other IDs
- U1111-1129-7907, JapicCTI-121816
- Status last verified
- Apr 2013
- First submitted
- 24 Apr 2012
- Last updated
- 16 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. 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
- NCT01585792
- Acronym / sponsor ID
- TAK-875/CPH-030
- Conditions
- Diabetic Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Apr 2012 (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
- Primary purpose
- Treatment
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAK-875 25 mg | Experimental | Drug: TAK-875 |
| TAK-875 50 mg | Experimental | Drug: TAK-875 |
| Glimepiride | Active comparator | Drug: Glimepiride |
| 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 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 |
|---|---|---|
| TAK-875 | Drug | TAK-875 25 mg |
| TAK-875 | Drug | TAK-875 50 mg |
| Glimepiride | Drug | Glimepiride |
| Placebo | Drug | Placebo |
Primary outcome
Blood glucose
Time frame: 4 weeks
Blood glucose
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 16 Apr 2013.
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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.
2 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 and Glimepiride in people with Diabetic Patients, run by Takeda at 2 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 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Blood glucose (time frame: 4 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 16 Apr 2013.