This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
267
Escalating doses po bid
po bid
HbA1c mean change from baseline, compared to placebo.
Time frame: Week 12
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
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Tucson, Arizona, United States
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Pine Bluff, Arkansas, United States
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Chula Vista, California, United States
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Spring Valley, California, United States
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West Hills, California, United States
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Hollywood, Florida, United States
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Atlanta, Georgia, United States
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Binghamton, New York, United States
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Fayetteville, North Carolina, United States
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Statesville, North Carolina, United States
...and 34 more locations