Diabetes, Type 2Phase 2NCT00857558
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
A Phase 2 study testing saxagliptin in people with Diabetes, Type 2, run by Kyowa Kirin Co., Ltd. at 8 sites in Japan.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes, Type 2
- What is being tested?
- saxagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 8 sitesJapan
- Study dates
- Jan 2009to May 2010
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients with HbA1c above 7.0% 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
Who cannot join
- Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetes coma
- Patients with poorly-controlled hypertension
- Patients with heart failure
- Patients with a complication of active hepatitis or hepatic cirrhosis
- Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
- Patients with a history or complication of malignant tumor
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chubu Regin
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes
- Conditions
- Diabetes, Type 2
- Being tested
- saxagliptin, 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.
saxagliptinDrug
orally administration at 1 mg once a day for 12 weeks
saxagliptinDrug
orally administration at 2.5 mg once a day for 12 weeks
saxagliptinDrug
orally administration at 5 mg once a day for 12 weeks
placeboDrug
orally administration once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OPC-262 1mg Receives: Drug: saxagliptin |
| 2 | Experimental | OPC-262 2.5mg Receives: Drug: saxagliptin |
| 3 | Experimental | OPC-262 5mg Receives: Drug: saxagliptin |
| 4 | Placebo comparator | Not described 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: 2w, 4w, 8w, 12w, 16w
Secondary outcomes (3)
values and changes in HbA1c form baseline
Measured: 2w, 4w, 8w, 12w, 16w
values and changes in fasting blood glucose (FSB) from baseline
Measured: 2w, 4w, 8w, 12w, 16w
adverse event
Measured: at any time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionMay 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Saito, Study director, OPC-J
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857558
- Sponsor's protocol ID
- 262-08-001
- Other IDs
- JapicCTI-090697
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2009
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00857558
- Acronym / sponsor ID
- 262-08-001
- Conditions
- Diabetes, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Mar 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.
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: saxagliptinOPC-262 1mg |
| 2 | Experimental | Drug: saxagliptinOPC-262 2.5mg |
| 3 | Experimental | Drug: saxagliptinOPC-262 5mg |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes patients with HbA1c above 7.0% 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
Key exclusion criteria (7 listed)
- Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetes 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 |
|---|---|---|
| saxagliptinorally administration at 1 mg once a day for 12 weeks | Drug | 1 |
| saxagliptinorally administration at 2.5 mg once a day for 12 weeks | Drug | 2 |
| saxagliptinorally administration at 5 mg once a day for 12 weeks | Drug | 3 |
| placeboorally administration once a day for 12 weeks | Drug | 4 |
Primary outcome
changes in HbA1C from baseline
Time frame: 2w, 4w, 8w, 12w, 16w
3 secondary outcomes
values and changes in HbA1c form baseline
Time frame: 2w, 4w, 8w, 12w, 16w
values and changes in fasting blood glucose (FSB) from baseline
Time frame: 2w, 4w, 8w, 12w, 16w
adverse event
Time frame: at any time
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 9 Mar 2017.
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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.
Katsuhisa Saito study director
OPC-J
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saxagliptin in people with Diabetes, Type 2, run by Kyowa Kirin Co., Ltd. at 8 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 2w, 4w, 8w, 12w, 16w). 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 9 Mar 2017.