This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
placebo, oral tablet administered once daily on background of pioglitazone
dutogliptin, oral tablet administered once daily on background of pioglitazone
Hemoglobin A1c Level (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) and Week 8 (Week 26)
Fasting Plasma Glucose Level (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) and 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 059
Chandler, Arizona, United States
Forest Investigative Site 096
Litchfield, Arizona, United States
Forest Investigative Site 098
Phoenix, Arizona, United States
Forest Investigative Site 044
Scottsdale, Arizona, United States
Forest Investigative Site 087
Tucson, Arizona, United States
Forest Investigative Site 061
Anaheim, California, United States
Forest Investigative Site 041
Chula Vista, California, United States
Forest Investigative Site 049
Encinitas, California, United States
...and 108 more locations