A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
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
1 other identifier
interventional
259
10 countries
58
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Feb 2006
Typical duration for phase_2 diabetes-mellitus-type-2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 20, 2006
CompletedFirst Posted
Study publicly available on registry
April 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 2, 2016
November 1, 2016
1.7 years
April 20, 2006
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
AEs, laboratory parameters, ECG.
Throughout study
Secondary Outcomes (1)
Mean change from original baseline in HbA1c, FPG, lipid profile.
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- type 1 diabetes mellitus;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Unknown Facility
Chula Vista, California, 91910, United States
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Spring Valley, California, 91978, United States
Unknown Facility
West Hills, California, 91307, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Arkansas City, Kansas, 67005, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Binghamton, New York, 13901, United States
Unknown Facility
Fayetteville, North Carolina, 28304, United States
Unknown Facility
Statesville, North Carolina, 28625, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Springdale, Ohio, 45246, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Beaver, Pennsylvania, 15009, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Federal Way, Washington, 98003, United States
Unknown Facility
Renton, Washington, 98055, United States
Unknown Facility
Camperdown, 2050, Australia
Unknown Facility
Heidelberg, 3081, Australia
Unknown Facility
Dimitrovgrad, 6400, Bulgaria
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Rousse, 7002, Bulgaria
Unknown Facility
Sofia, 1233, Bulgaria
Unknown Facility
Sofia, 1606, Bulgaria
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
London, Ontario, NGA 4V2, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Zagreb, 10000, Croatia
Unknown Facility
Bammental, 69245, Germany
Unknown Facility
Berlin, 10115, Germany
Unknown Facility
Essen, 45355, Germany
Unknown Facility
Giessen, 35385, Germany
Unknown Facility
Görlitz, 02826, Germany
Unknown Facility
Hamburg, 20249, Germany
Unknown Facility
Künzing, 94550, Germany
Unknown Facility
Nuremberg, 90402, Germany
Unknown Facility
Tann, 36142, Germany
Unknown Facility
Guatemala City, 01015, Guatemala
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Chihuahua City, 31238, Mexico
Unknown Facility
Cuernavaca, 62270, Mexico
Unknown Facility
Durango, 34070, Mexico
Unknown Facility
Mexico City, 06700, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Mexico City, 14050, Mexico
Unknown Facility
Mexico City, 14610, Mexico
Unknown Facility
Bialystok, 15-276, Poland
Unknown Facility
Gdansk, 80-757, Poland
Unknown Facility
Gorzów, 66-400, Poland
Unknown Facility
Krakow, 31-121, Poland
Unknown Facility
Wroclaw, 50-088, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2006
First Posted
April 21, 2006
Study Start
February 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11