This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
677
Dutogliptin oral administration once daily on background of glimepiride with or without metformin
Placebo, oral administration once daily on background of glimepiride with or without metformin
Hemoglobin A1c (HbA1c)
Time frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
Fasting Plasma Glucose (FPG)
Time frame: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18), Visit 8 (Week 26).
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Forest Investigative Site 064
Birmingham, Alabama, United States
Forest Investigative Site 020
Birmingham, Alabama, United States
Forest Investigative Site 025
Muscle Shoals, Alabama, United States
Forest Investigative Site 059
Chandler, Arizona, United States
Forest Investigative Site 113
Gilbert, Arizona, United States
Forest Investigative Site 096
Litchfield, Arizona, United States
Forest Investigative Site 080
Peoria, Arizona, United States
Forest Investigative Site 098
Phoenix, Arizona, United States
Forest Investigative Site 044
Scottsdale, Arizona, United States
Forest Investigative Site 061
Anaheim, California, United States
...and 137 more locations