A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
10 mg/day and 25 mg/day
1-6 mg/day
Reduction in glycosylated hemoglobin A1c
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Time frame: Randomization to 69 weeks
Reduction in weight
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Time frame: Randomization to 69 weeks
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Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, United States
Thomas C. Lenzmeier, M.D., P.C.
Glendale, Arizona, United States
Family Practice Specialists
Phoenix, Arizona, United States
Central Phoenix Medical Center
Phoenix, Arizona, United States
Fiel Family and Sports Medicine
Tempe, Arizona, United States
Arizona Community Physicians
Tucson, Arizona, United States
Orange Grove Family Practice
Tucson, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Radiant Research
Carlsbad, California, United States
Research Center of Fresno, Inc.
Fresno, California, United States
...and 91 more locations