Diabetes Mellitus Type 2Phase 2NCT00316758
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
A Phase 2 study testing GK Activator (2) and Metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 58 sites in 10 countries.
Trial summary
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- GK Activator (2) and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 58 sitesin 10 countries
- Study dates
- Feb 2006to Oct 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetic patients who have completed studies BM18248 or BM18249;
- patients considered by the investigator to be suitable for long term treatment with GK Activator (2).
Who cannot join
- type 1 diabetes mellitus;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Trial locations and contacts
58 sites in 10 countries.
58 sites in 10 countries
United States22 sites
Study site
Arkansas City, Kansas, 67005
Study site
Atlanta, Georgia, 30308
Study site
Beaver, Pennsylvania, 15009
Study site
Binghamton, New York, 13901
Study site
Butte, Montana, 59701
Study site
Chula Vista, California, 91910
Study site
Chula Vista, California, 91911
Study site
Fayetteville, North Carolina, 28304
Study site
Federal Way, Washington, 98003
Study site
Hollywood, Florida, 33021
Study site
Kissimmee, Florida, 34741
Study site
Los Angeles, California, 90057
Study site
Medford, Oregon, 97504
Study site
Memphis, Tennessee, 38119
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Oklahoma City, Oklahoma, 73112
Study site
Renton, Washington, 98055
Study site
Spring Valley, California, 91978
Study site
Springdale, Ohio, 45246
Study site
Statesville, North Carolina, 28625
Study site
West Hills, California, 91307
Study site
Winston-Salem, North Carolina, 27103
Germany9 sites
Study site
Bammental, 69245
Study site
Berlin, 10115
Study site
Essen, 45355
Study site
Giessen, 35385
Study site
Görlitz, 02826
Study site
Hamburg, 20249
Study site
Künzing, 94550
Study site
Nuremberg, 90402
Study site
Tann, 36142
Mexico7 sites
Study site
Chihuahua City, 31238
Study site
Cuernavaca, 62270
Study site
Durango, 34070
Study site
Mexico City, 06700
Study site
Mexico City, 11650
Study site
Mexico City, 14050
Study site
Mexico City, 14610
Bulgaria5 sites
Study site
Dimitrovgrad, 6400
Study site
Pleven, 5800
Study site
Rousse, 7002
Study site
Sofia, 1233
Study site
Sofia, 1606
Poland5 sites
Study site
Bialystok, 15-276
Study site
Gdansk, 80-757
Study site
Gorzów, 66-400
Study site
Krakow, 31-121
Study site
Wroclaw, 50-088
Canada3 sites
Study site
London, Ontario, NGA 4V2
Study site
Montreal, Quebec, H1T 2M4
Study site
Vancouver, British Columbia, V5Z 1M9
Hungary3 sites
Study site
Budapest, 1083
Study site
Győr, 9024
Study site
Kecskemét, 6000
About this study
Official title: A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- GK Activator (2), Metformin
- 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
Escalating doses bid
MetforminDrug
As prescribed, in patients who were in study BM18249
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GK Activator (2); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs, laboratory parameters, ECG.
Measured: Throughout study
Secondary outcomes (1)
Mean change from original baseline in HbA1c, FPG, lipid profile.
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 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2007
- Study completionOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 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
- NCT00316758
- Sponsor's protocol ID
- NC19794
- Status last verified
- Nov 2016
- First submitted
- 20 Apr 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
- A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
- ClinicalTrials.gov ID
- NCT00316758
- Acronym / sponsor ID
- NC19794
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 21 Apr 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 evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GK Activator (2), Drug: Metformin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetic patients who have completed studies BM18248 or BM18249;
- patients considered by the investigator to be suitable for long term treatment with GK Activator (2).
Key exclusion criteria (2 listed)
- type 1 diabetes mellitus;
- 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)Escalating doses bid | Drug | 1 |
| MetforminAs prescribed, in patients who were in study BM18249 | Drug | 1 |
Primary outcome
AEs, laboratory parameters, ECG.
Time frame: Throughout study
1 secondary outcome
Mean change from original baseline in HbA1c, FPG, lipid profile.
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
58 sites in 10 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) and Metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 58 sites in 10 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: 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 58 sites in United States, Germany, Mexico, Bulgaria, Poland and 5 more countries. 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?
AEs, laboratory parameters, ECG. (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.