Diabetes MellitusPhase 4NCT01686711
A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322
A Phase 4 study testing AD-4833 15 mg and AD-4833 30 mg in people with Diabetes Mellitus, run by Takeda at 25 sites in Japan.
Trial summary
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus. 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?
- AD-4833 15 mg and AD-4833 30 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 25 sitesJapan
- Study dates
- Sep 2012to Dec 2013
- Phase
- Phase 4
- 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
- Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
- Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.
Who cannot join
- Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
- Others who are assessed to be ineligible for the study by the investigator or subinvestigator.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Study site
Chiyoda-ku, Tokyo
Study site
Chuo-ku, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Fukuyama-shi, Hiroshima
Study site
Hirosaki-shi, Aomori
Study site
Hiroshima, Hiroshima
Study site
Itabashi-ku, Tokyo
Study site
Kisaratsu-shi, Chiba
Study site
Kitakyushu-shi, Fukuoka
Study site
Koga-shi, Ibaraki
Study site
Koshigaya-shi, Saitama
Study site
Kumamoto, Kumamoto
Study site
Kurume-shi, Fukuoka
Study site
Matsuyama, Ehime
Study site
Meguro-ku, Tokyo
Study site
Minato-ku, Tokyo
Study site
Miyazaki, Miyazaki
Study site
Ohta-ku, Tokyo
Study site
Ōtsu, Shiga
Study site
Sapporo, Hokkaido
Study site
Shimonoseki-shi, Yamaguchi
Study site
Shinjuku-ku, Tokyo
Study site
Suita-shi, Osaka
Study site
Toyama, Toyama
Study site
Yokohama, Kanagawa
About this study
Official title: A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
- Conditions
- Diabetes Mellitus
- Being tested
- AD-4833 15 mg, AD-4833 30 mg, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-4833 15 mgDrug
AD-4833 30 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SYR-322 25 mg , AD-4833 15 mg | Experimental | Not described Receives: Drug: AD-4833 15 mg |
| SYR-322 25 mg , AD-4833 30 mg | Experimental | Not described Receives: Drug: AD-4833 30 mg |
| SYR-322 25 mg , AD-4833 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.
Glycosylated Hemoglobin (HbA1c)
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686711
- Sponsor's protocol ID
- SYR-322-4833/CCT-901
- Other IDs
- U1111-1132-3209, JapicCTI-121916
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2012
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy
- ClinicalTrials.gov ID
- NCT01686711
- Acronym / sponsor ID
- SYR-322-4833/CCT-901
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Sep 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.
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SYR-322 25 mg , AD-4833 15 mg | Experimental | Drug: AD-4833 15 mg |
| SYR-322 25 mg , AD-4833 30 mg | Experimental | Drug: AD-4833 30 mg |
| SYR-322 25 mg , AD-4833 placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
- Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.
Key exclusion criteria (2 listed)
- Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
- Others who are assessed to be ineligible for the study 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 |
|---|---|---|
| AD-4833 15 mg | Drug | SYR-322 25 mg , AD-4833 15 mg |
| AD-4833 30 mg | Drug | SYR-322 25 mg , AD-4833 30 mg |
| Placebo | Drug | SYR-322 25 mg , AD-4833 placebo |
Primary outcome
Glycosylated Hemoglobin (HbA1c)
Time frame: 16 weeks
Measurement of change in HbA1c (ratio of hemoglobin bound to 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 31 Aug 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.
Study Director study director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AD-4833 15 mg and AD-4833 30 mg in people with Diabetes Mellitus, run by Takeda at 25 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Glycosylated Hemoglobin (HbA1c) (time frame: 16 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 31 Aug 2023.