Diabetes, Type 2Phase 3NCT01193179
A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes
A Phase 3 study testing OPC-262 in people with Diabetes, Type 2, run by Kyowa Kirin Co., Ltd. at 4 sites in Japan.
Trial summary
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes, Type 2
- What is being tested?
- OPC-262
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 4 sitesJapan
- Study dates
- Jul 2010to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients who are capable of giving informed consent
- 2) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner
Who cannot join
- Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Kanto Rigeon
Study site
Kinki Region
Study site
Kyushu Region
Study site
Tohoku Region
About this study
Official title: Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent
- Conditions
- Diabetes, Type 2
- Being tested
- OPC-262
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-262Drug
Oral administration of tablets for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| OPC-262 | Experimental | Not described Receives: Drug: OPC-262 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, clinical laboratory tests
Measured: 52 weeks
Secondary outcomes (1)
Secondary Outcome HbA1c
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 posted1 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 2Studies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193179
- Sponsor's protocol ID
- 262-10-005
- Other IDs
- JapicCTI-101252
- Status last verified
- Jan 2014
- First submitted
- 30 Aug 2010
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01193179
- Acronym / sponsor ID
- 262-10-005
- Conditions
- Diabetes, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Sep 2010 (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 investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPC-262 | Experimental | Drug: OPC-262 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Patients who are capable of giving informed consent
- 2) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner
Key exclusion criteria (1 listed)
- Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
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 |
|---|---|---|
| OPC-262Oral administration of tablets for 52 weeks | Drug | OPC-262 |
Primary outcome
Adverse events, clinical laboratory tests
Time frame: 52 weeks
1 secondary outcome
Secondary Outcome HbA1c
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 8 Jan 2014.
Related trials for Diabetes, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
4 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 OPC-262 in people with Diabetes, Type 2, run by Kyowa Kirin Co., Ltd. at 4 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 1 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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, clinical laboratory tests (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 8 Jan 2014.