A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
NCT ID: NCT00266253
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2005-11-30
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Metformin
As prescribed, for 12 weeks
2
GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Metformin
As prescribed, for 12 weeks
3
GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Metformin
As prescribed, for 12 weeks
4
GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Metformin
As prescribed, for 12 weeks
5
GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Metformin
As prescribed, for 12 weeks
6
Metformin
As prescribed, for 12 weeks
Interventions
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GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.
Metformin
As prescribed, for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes mellitus;
* individual maximal tolerated daily dose of metformin monotherapy for \>=3 months prior to screening.
Exclusion Criteria
* any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
30 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Phoenix, Arizona, United States
Chula Vista, California, United States
Los Angeles, California, United States
Kissimmee, Florida, United States
Tampa, Florida, United States
Lawrenceville, Georgia, United States
Arkansas City, Kansas, United States
Benzonia, Michigan, United States
Springfield, Missouri, United States
Butte, Montana, United States
Kettering, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Morrisville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Bellevue, Washington, United States
Federal Way, Washington, United States
Adelaide, , Australia
Heidelberg, , Australia
Sydney, , Australia
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Bammental, , Germany
Berlin, , Germany
Essen, , Germany
Giessen, , Germany
Görlitz, , Germany
Hamburg, , Germany
Künzing, , Germany
Mannheim, , Germany
Nuremberg, , Germany
Tann, , Germany
Alzira, , Spain
Bacarot Alicant, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Dundee, , United Kingdom
Frome, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Motherwell, , United Kingdom
Northwood, , United Kingdom
Plymouth, , United Kingdom
Countries
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Other Identifiers
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BM18249
Identifier Type: -
Identifier Source: org_study_id