Diabetes MellitusPhase 3NCT01521962
Study of Combination Therapy With SYR-322
A Phase 3 study testing Alogliptin and Insulin in people with Diabetes Mellitus, run by Takeda at 33 sites in Japan.
Trial summary
To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin. 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?
- Alogliptin and Insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 33 sitesJapan
- Study dates
- Feb 2012to Mar 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 subject is an outpatient.
- The subject 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 subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Study site
Aki-gun, Hiroshima
Study site
Aomori, Aomori
Study site
Fukuyama-shi, Hiroshima
Study site
Hamamatsu, Shizuoka
Study site
Hanamaki-shi, Iwate
Study site
Hirakata-shi, Osaka
Study site
Hirosaki-shi, Aomori
Study site
Kagoshima, Kagoshima-ken
Study site
Kahoku-gun, Ishikawa-ken
Study site
Kashiwa-shi, Chiba
Study site
Kisarazu-shi, Chiba
Study site
Kitakyushu-shi, Fukuoka
Study site
Koga-shi, Ibaraki
Study site
Kuki-shi, Saitama
Study site
Kumamoto, Kumamoto
Study site
Minamata-shi, Kumamoto
Study site
Miyazaki, Miyazaki
Study site
Morioka, Iwate
Study site
Nigata-shi, Niigata
Study site
Nishinomiya-shi, Hyōgo
Study site
Osaka, Osaka
Study site
Osaka-sayama-shi, Osaka
Study site
Ōtsu, Shiga
Study site
Sagae-shi, Yamagata
Study site
Satsuma-sendai-shi, Kagoshima-ken
Study site
Shimotsuke-shi, Tochigi
Study site
Shinagawa-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Takatsuki-shi, Osaka
Study site
Toyama, Toyama
Study site
Ushiku-shi, Ibaraki
Study site
Yamagata, Yamagata
Study site
Yao-shi, Osaka
About this study
Official title: A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan
To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.
- Conditions
- Diabetes Mellitus
- Being tested
- Alogliptin, Insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlogliptinDrug
Also called SYR-322
Alogliptin tablets
InsulinDrug
Insulin injection
| Study group | Role | What they receive |
|---|---|---|
| SYR-322 (Alogliptin) QD | Experimental | SYR-322 25 mg, orally. Receives: Drug: Alogliptin |
| Insulin | Placebo comparator | injection Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Manager, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521962
- Sponsor's protocol ID
- SYR-322/CCT-901
- Other IDs
- U1111-1127-1525, JapicCTI-121736
- Status last verified
- Nov 2013
- First submitted
- 26 Jan 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
Publications
Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.
PubMed 25190226
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan
- ClinicalTrials.gov ID
- NCT01521962
- Acronym / sponsor ID
- SYR-322/CCT-901
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Jan 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 determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYR-322 (Alogliptin) QD | Experimental | Drug: AlogliptinSYR-322 25 mg, orally. |
| Insulin | Placebo comparator | Drug: Insulininjection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject is an outpatient.
- The subject 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 subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The subject 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 |
|---|---|---|
| AlogliptinAlso: SYR-322Alogliptin tablets | Drug | SYR-322 (Alogliptin) QD |
| InsulinInsulin injection | Drug | Insulin |
Primary outcome
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)
Time frame: Baseline and Week 12
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 13 Nov 2013.
- Derived from this study: PubMed 25190226Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.
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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 Manager study director
Takeda
33 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 Alogliptin and Insulin in people with Diabetes Mellitus, run by Takeda at 33 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521962, which also lists 1 linked publication.
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 13 Nov 2013.