Diabetes Mellitus, Type 2Phase 2NCT00370942
GW823093C For The Treatment Of Type 2 Diabetes Mellitus
A Phase 2 study testing GW823093C A, GW823093C B and GW823093C C in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial summary
This study was designed to find dose response and as extension in treatment of GW823093C. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GW823093C A, GW823093C B and GW823093C C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Apr 2006to 25 Nov 2006
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus.
- Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))
Who cannot join
- Patients who have metabolic disease judged by investigator as a clinically significance
- Serious cardiovascular disease or serious hepatic disease
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Japan4 sites
GSK Investigational Site
Hokkaido, 051-0005
GSK Investigational Site
Miyagi, 985-0852
GSK Investigational Site
Tokyo, 130-0004
GSK Investigational Site
Tokyo, 160-0017
Location not given1 site
GSK Investigational Site
About this study
Official title: GW823093 Japan Phase IIa Mono
This study was designed to find dose response and as extension in treatment of GW823093C.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GW823093C A, GW823093C B, GW823093C C
- Keywords
- GW823093C, diabetes, type 2 diabetes mellitus, DPP-IV inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW823093C ADrug
A=45 mg
GW823093C BDrug
B=30 mg
GW823093C CDrug
C=25 mg
| Study group | Role | What they receive |
|---|---|---|
| GW823093C A | Placebo comparator | A=45 mg Receives: Drug: GW823093C A |
| GW823093C B | Placebo comparator | B=30 mg Receives: Drug: GW823093C B |
| GW823093C C | Placebo comparator | C=15 mg Receives: Drug: GW823093C C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Measured: 12 weeks
Secondary outcomes (1)
Long term safety variables
Measured: 64 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 2006 (estimated)
- Study start1 Apr 2006
- Primary completion1 Nov 2006
- Study completion25 Nov 2006
Why it stopped: Safety issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370942
- Sponsor's protocol ID
- DPB106652
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2006
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GW823093 Japan Phase IIa Mono
- ClinicalTrials.gov ID
- NCT00370942
- Acronym / sponsor ID
- DPB106652
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GW823093C, diabetes, type 2 diabetes mellitus, DPP-IV inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety issue
- Enrolment
- 159 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2006
- Primary completion
- 1 Nov 2006 (actual)
- Study completion
- 25 Nov 2006 (actual)
- First posted
- 1 Sep 2006 (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.
This study was designed to find dose response and as extension in treatment of GW823093C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GW823093C A | Placebo comparator | Drug: GW823093C AA=45 mg |
| GW823093C B | Placebo comparator | Drug: GW823093C BB=30 mg |
| GW823093C C | Placebo comparator | Drug: GW823093C CC=15 mg |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus.
- Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))
Key exclusion criteria (2 listed)
- Patients who have metabolic disease judged by investigator as a clinically significance
- Serious cardiovascular disease or serious hepatic disease
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 |
|---|---|---|
| GW823093C AA=45 mg | Drug | GW823093C A |
| GW823093C BB=30 mg | Drug | GW823093C B |
| GW823093C CC=25 mg | Drug | GW823093C C |
Primary outcome
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Time frame: 12 weeks
1 secondary outcome
Long term safety variables
Time frame: 64 weeks
Results and safety
The study was stopped early (reason given: Safety issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW823093C A, GW823093C B and GW823093C C in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 5 sites in 2 countries.
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: stopped early, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early (reason given: Safety issue). Results are not available in the source record.
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?
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group (time frame: 12 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 31 Aug 2018.