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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
259
Escalating doses bid
As prescribed, in patients who were in study BM18249
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Chula Vista, California, United States
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Chula Vista, California, United States
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Los Angeles, California, United States
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Spring Valley, California, United States
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West Hills, California, United States
Unnamed facility
AEs, laboratory parameters, ECG.
Time frame: Throughout study
Mean change from original baseline in HbA1c, FPG, lipid profile.
Time frame: Throughout study
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Hollywood, Florida, United States
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Kissimmee, Florida, United States
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Atlanta, Georgia, United States
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Arkansas City, Kansas, United States
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Butte, Montana, United States
...and 48 more locations