Type 2 DiabetesPhase 3NCT01333592
Long-term Study of KAD-1229 in Type 2 Diabetes Patients
A Phase 3 study testing KAD-1229 in people with Type 2 Diabetes, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- KAD-1229
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy
- Age in the 20 years or over inclusive
- HbA1c in the range of ≥ 6.5 to < 9%
Who cannot join
- Type 1 diabetes mellitus
- Patients with serious diabetic complications and other serious complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy
The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.
- Conditions
- Type 2 Diabetes
- Being tested
- KAD-1229
- Keywords
- Type 2 diabetes, HbA1c, Long-term study
- 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.
KAD-1229Drug
| Study group | Role | What they receive |
|---|---|---|
| KAD-1229 | Experimental | Not described Receives: Drug: KAD-1229 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Adverse Events
Measured: 52 weeks
Secondary outcomes (1)
Change From Baseline in HbA1c at 52 Weeks
Measured: at week 0 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333592
- Sponsor's protocol ID
- KAD4301
- Status last verified
- Nov 2014
- First submitted
- 6 Apr 2011
- Last updated
- 15 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy
- ClinicalTrials.gov ID
- NCT01333592
- Acronym / sponsor ID
- KAD4301
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, HbA1c, Long-term study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 24 Nov 2014
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 evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KAD-1229 | Experimental | Drug: KAD-1229 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy
- Age in the 20 years or over inclusive
- HbA1c in the range of ≥ 6.5 to < 9%
Key exclusion criteria (2 listed)
- Type 1 diabetes mellitus
- Patients with serious diabetic complications and other serious complications
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 |
|---|---|---|
| KAD-1229 | Drug | KAD-1229 |
Primary outcome
Incidences of Adverse Events
Time frame: 52 weeks
1 secondary outcome
Change From Baseline in HbA1c at 52 Weeks
Time frame: at week 0 and week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KAD-1229 in people with Type 2 Diabetes, run by Kissei Pharmaceutical Co., Ltd. at 1 site 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 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 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidences of Adverse Events (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 15 Dec 2014.