This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) \< 30 mL/min) for a period of 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
50mg qd
25mg qd
Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)
Time frame: 52 weeks
To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment
Time frame: 52 weeks
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University of South Alabama Medical Center
Mobile, Alabama, United States
Anasazi Internal Medicine
Phoenix, Arizona, United States
Sonoran Health Specialists
Scottsdale, Arizona, United States
Mary K. Richards, MD. PA
Little Rock, Arkansas, United States
University of Arkanasas for Medical Sciences
Little Rock, Arkansas, United States
Unnamed facility
Burlingame, California, United States
John Muir Clinical Research
Concord, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Northern California Institute for Bone Health
Oakland, California, United States
...and 77 more locations