Diabetes Mellitus Type 2Phase 2NCT00266253
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
A Phase 2 study testing GK Activator (2) and Metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 47 sites in 6 countries.
Trial summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. 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
- 220 participants
- Where
- 47 sitesin 6 countries
- Study dates
- Nov 2005to Mar 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
- adult patients 30-75 years of age;
- type 2 diabetes mellitus;
- individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.
Who cannot join
- type 1 diabetes mellitus;
- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
United States18 sites
Study site
Arkansas City, Kansas, 67005
Study site
Bellevue, Washington, 98004
Study site
Benzonia, Michigan, 49616
Study site
Butte, Montana, 59701
Study site
Chula Vista, California, 91910
Study site
Federal Way, Washington, 98003
Study site
Kettering, Ohio, 45429
Study site
Kissimmee, Florida, 34741
Study site
Lawrenceville, Georgia, 30045
Study site
Los Angeles, California, 90057
Study site
Medford, Oregon, 97504
Study site
Memphis, Tennessee, 38119
Study site
Morrisville, Pennsylvania, 19067
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85012
Study site
Springfield, Missouri, 65804
Study site
Tampa, Florida, 33603
Study site
Tulsa, Oklahoma, 74104
Germany10 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
Mannheim, 68161
Study site
Nuremberg, 90402
Study site
Tann, 36142
United Kingdom7 sites
Study site
Dundee, DD1 5LA
Study site
Frome, BA11 1EZ
Study site
Glasgow, G45 9AW
Study site
Liverpool, L9 7AL
Study site
Motherwell, ML1 3JX
Study site
Northwood, HA6 2RN
Study site
Plymouth, PL6 7TH
Canada5 sites
Study site
Edmonton, Alberta, T5N 3Y6
Study site
London, Ontario, NGA 4V2
Study site
Montreal, Quebec, H1T 2M4
Study site
Sherbrooke, Quebec, J1H 4J6
Study site
Vancouver, British Columbia, V5Z 1M9
Spain4 sites
Study site
Alzira, 46600
Study site
Bacarot Alicant, 03114
Study site
Barakaldo, 48903
Study site
Barcelona, 08036
Australia3 sites
Study site
Adelaide, 5000
Study site
Heidelberg, 3081
Study site
Sydney, 2050
About this study
Official title: A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 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, po bid or qd for 12 weeks.
MetforminDrug
As prescribed, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GK Activator (2); Drug: Metformin |
| 2 | Experimental | Not described Receives: Drug: GK Activator (2); Drug: Metformin |
| 3 | Experimental | Not described Receives: Drug: GK Activator (2); Drug: Metformin |
| 4 | Experimental | Not described Receives: Drug: GK Activator (2); Drug: Metformin |
| 5 | Experimental | Not described Receives: Drug: GK Activator (2); Drug: Metformin |
| 6 | Active comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c mean change from baseline compared with placebo.
Measured: Week 12
Secondary outcomes (3)
Additional parameters of glycemic and lipid control.
Measured: Week 12
AEs, laboratory parameters.
Measured: Throughout study
Pharmacokinetic and exposure-response relationship
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 posted16 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2007
- Study completionMar 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 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
- NCT00266253
- Sponsor's protocol ID
- BM18249
- Status last verified
- Nov 2016
- First submitted
- 15 Dec 2005
- 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 Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
- ClinicalTrials.gov ID
- NCT00266253
- Acronym / sponsor ID
- BM18249
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Dec 2005 (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 efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GK Activator (2), Drug: Metformin |
| 2 | Experimental | Drug: GK Activator (2), Drug: Metformin |
| 3 | Experimental | Drug: GK Activator (2), Drug: Metformin |
| 4 | Experimental | Drug: GK Activator (2), Drug: Metformin |
| 5 | Experimental | Drug: GK Activator (2), Drug: Metformin |
| 6 | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients 30-75 years of age;
- type 2 diabetes mellitus;
- individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.
Key exclusion criteria (2 listed)
- type 1 diabetes mellitus;
- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
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, po bid or qd for 12 weeks. | Drug | 1, 2, 3, 4, 5 |
| MetforminAs prescribed, for 12 weeks | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
HbA1c mean change from baseline compared with placebo.
Time frame: Week 12
3 secondary outcomes
Additional parameters of glycemic and lipid control.
Time frame: Week 12
AEs, laboratory parameters.
Time frame: Throughout study
Pharmacokinetic and exposure-response relationship
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
47 sites in 6 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 47 sites in 6 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 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 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 47 sites in United States, Germany, United Kingdom, Canada, Spain and 1 more country. 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?
HbA1c mean change from baseline compared with placebo. (time frame: Week 12). 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.