Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
461
administered orally once daily
administered orally once daily
administered orally once daily
administered orally once daily
administered orally once daily
administered orally once daily
Research Site
Mesa, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Huntington Beach, California, United States
Research Site
Mean Change in HbA1c
Time frame: Baseline (randomization) to Week 26
Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
Time frame: week 26
Mean Change in Total Body Weight
Time frame: Baseline (randomization) to Week 26
Mean Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline (randomization) to Week 26
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Huntington Park, California, United States
Research Site
Lomita, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Norwalk, California, United States
...and 69 more locations