Primary objective: The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing. Secondary objectives: The secondary objectives are to: * Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator; * Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator; * Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator; * Describe the frequencies of adverse events in the treatment groups; and * Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
593
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Gulf Shores, Alabama, United States
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator
Time frame: Baseline and 20 weeks
Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator
Time frame: Up to 23 weeks
Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator
Time frame: Baseline and 20 weeks
Describe the frequencies of adverse events in the treatment groups
Time frame: Up to 23 weeks
Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing
Time frame: Baseline and 20 weeks
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Muscle Shoals, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Goodyear, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
...and 83 more locations