The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
166
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Tablets, Oral, Placebo, Twice daily, 12 weeks
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Mean change was adjusted for baseline.
Time frame: Baseline, Week 12
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
Mean change was adjusted for baseline.
Time frame: Baseline, Week 12
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12
Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Time frame: Week 12
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12
Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Time frame: Week 12
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John Muir Physician Network Clinical Research Center
Concord, California, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Torrance Clinical Research
Lomita, California, United States
Ritchken & First M.D.'S
San Diego, California, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States
Family Care Associates Of Nw Florida
Chipley, Florida, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States
Louisiana Heart Center Research
Slidell, Louisiana, United States
...and 31 more locations