Diabetes Type 2Phase 2/3NCT00997282
A Study of OPC-262 in Patients With Type 2 Diabetes
A Phase 2/3 study testing OPC-262 2.5 mg and OPC-262 5 mg in people with Diabetes Type 2, run by Kyowa Kirin Co., Ltd. at 7 sites in Japan.
Trial summary
The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- OPC-262 2.5 mg and OPC-262 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 7 sitesJapan
- Study dates
- Sep 2009to Oct 2010
- Phase
- Phase 2/3
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients with HbA1C above 6.5% and below 10%
- Patients who are capable of giving informed consent
- Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
Who cannot join
- Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetic coma
- Patients with poorly-controlled hypertension
- Patients with heart failure
- Patients with a complication of active hepatitis or hepatic cirrhosis
- Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
- Patients with a history or complication of malignant tumor
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)
The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.
- Conditions
- Diabetes Type 2
- Being tested
- OPC-262 2.5 mg, OPC-262 5 mg, Placebo
- 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-262 2.5 mgDrug
orally administered once daily for 24 weeks
OPC-262 5 mgDrug
orally administered once daily for 24 weeks
PlaceboDrug
orally administered once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| OPC-262 2.5 mg | Experimental | orally administered once daily for 24 weeks Receives: Drug: OPC-262 2.5 mg |
| OPC-262 5 mg | Experimental | orally administered once daily for 24 weeks Receives: Drug: OPC-262 5 mg |
| Placebo | Placebo comparator | orally administered once daily for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1C from baseline
Measured: Week 24 (LOCF)
Secondary outcomes (3)
Changes in fasting blood glucose (FBG) from baseline
Measured: Week 24
Changes in 2 hour postprandial blood glucose (PPG) from baseline
Measured: Week 24
Changes in 3 hour PPG AUC from baseline
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionOct 2010
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kaatsuhisa Saito, Study chair, OPCJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997282
- Sponsor's protocol ID
- 262-09-001
- Other IDs
- JapicCTI-090904
- Status last verified
- Jan 2014
- First submitted
- 16 Oct 2009
- 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
- A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)
- ClinicalTrials.gov ID
- NCT00997282
- Acronym / sponsor ID
- 262-09-001
- Conditions
- Diabetes Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Oct 2009 (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 clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPC-262 2.5 mg | Experimental | Drug: OPC-262 2.5 mgorally administered once daily for 24 weeks |
| OPC-262 5 mg | Experimental | Drug: OPC-262 5 mgorally administered once daily for 24 weeks |
| Placebo | Placebo comparator | Drug: Placeboorally administered once daily for 24 weeks |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes patients with HbA1C above 6.5% and below 10%
- Patients who are capable of giving informed consent
- Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
Key exclusion criteria (7 listed)
- Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetic coma
- Patients with poorly-controlled hypertension
- Patients with heart failure
- Patients with a complication of active hepatitis or hepatic cirrhosis
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-262 2.5 mgorally administered once daily for 24 weeks | Drug | OPC-262 2.5 mg |
| OPC-262 5 mgorally administered once daily for 24 weeks | Drug | OPC-262 5 mg |
| Placeboorally administered once daily for 24 weeks | Drug | Placebo |
Primary outcome
Changes in HbA1C from baseline
Time frame: Week 24 (LOCF)
3 secondary outcomes
Changes in fasting blood glucose (FBG) from baseline
Time frame: Week 24
Changes in 2 hour postprandial blood glucose (PPG) from baseline
Time frame: Week 24
Changes in 3 hour PPG AUC from baseline
Time frame: Week 24
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.
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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.
Kaatsuhisa Saito study chair
OPCJ
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OPC-262 2.5 mg and OPC-262 5 mg in people with Diabetes Type 2, run by Kyowa Kirin Co., Ltd. at 7 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 3 inclusion and 7 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 7 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in HbA1C from baseline (time frame: Week 24 (LOCF)). 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.