Diabetes Mellitus Type 2Phase 2NCT00366379
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
A Phase 2 study testing GK Activator (2) in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 21 sites in 4 countries.
Trial summary
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- GK Activator (2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Jul 2006to Jun 2007
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.
Who cannot join
- type 1 diabetes mellitus;
- treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States10 sites
Study site
Butte, Montana, 59701
Study site
Canton, Ohio, 44718
Study site
Chandler, Arizona, 85225
Study site
Evansville, Indiana, 47714
Study site
Greer, South Carolina, 29651
Study site
Midland, Texas, 79707
Study site
Nampa, Idaho, 83687
Study site
Oviedo, Florida, 32765
Study site
Portland, Oregon, 97239
Study site
Richmond, Virginia, 23249
Estonia4 sites
Study site
Tallinn, 10138
Study site
Tartu, 50406
Study site
Tartu, 50708
Study site
Tartu, 51014
Mexico4 sites
Study site
Chihuahua City, 31238
Study site
Guadalajara, 44340
Study site
Guadalajara, 44650
Study site
Pachuca, 42086
Latvia3 sites
Study site
Jelgava, 3001
Study site
Riga, 1002
Study site
Riga, 1038
About this study
Official title: An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- GK Activator (2)
- 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.
GK Activator (2)Drug
25-200mg po bid for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GK Activator (2) |
| 2 | Experimental | Not described Receives: Drug: GK Activator (2) |
| 3 | Experimental | Not described Receives: Drug: GK Activator (2) |
| 4 | Experimental | Not described Receives: Drug: GK Activator (2) |
| 5 | Experimental | Not described Receives: Drug: GK Activator (2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients at each dose who achieve FPG <100mg/dL.
Measured: Throughout study
Secondary outcomes (2)
Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.
Measured: At intervals throughout study
AEs, laboratory parameters.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionJun 2007
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 Hoffmann-La RocheThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366379
- Sponsor's protocol ID
- BC19800
- Status last verified
- Nov 2016
- First submitted
- 16 Aug 2006
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.
- ClinicalTrials.gov ID
- NCT00366379
- Acronym / sponsor ID
- BC19800
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Aug 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 will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GK Activator (2) |
| 2 | Experimental | Drug: GK Activator (2) |
| 3 | Experimental | Drug: GK Activator (2) |
| 4 | Experimental | Drug: GK Activator (2) |
| 5 | Experimental | Drug: GK Activator (2) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.
Key exclusion criteria (3 listed)
- type 1 diabetes mellitus;
- treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
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 |
|---|---|---|
| GK Activator (2)25-200mg po bid for 20 weeks | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Percentage of patients at each dose who achieve FPG <100mg/dL.
Time frame: Throughout study
2 secondary outcomes
Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.
Time frame: At intervals throughout study
AEs, laboratory parameters.
Time frame: Throughout study
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GK Activator (2) in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 21 sites in 4 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 3 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Estonia, Mexico, Latvia. 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 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?
Percentage of patients at each dose who achieve FPG <100mg/dL. (time frame: Throughout study). 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 2 Nov 2016.