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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Escalating doses, po bid or qd for 12 weeks.
As prescribed, for 12 weeks
HbA1c mean change from baseline compared with 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Chula Vista, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Kissimmee, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Lawrenceville, Georgia, United States
Unnamed facility
Arkansas City, Kansas, United States
Unnamed facility
Benzonia, Michigan, United States
Unnamed facility
Springfield, Missouri, United States
Unnamed facility
Butte, Montana, United States
...and 37 more locations