The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
365
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Time frame: Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
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Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Tomac, Inc.
Columbiana, Alabama, United States
Winston Technology, Inc.
Haleyville, Alabama, United States
Clinical Reseacrh Advantage/ Brown Family Medicine
Mesa, Arizona, United States
Strategos Medical Group
Bakersfield, California, United States
Providence Clinical Research
Burbank, California, United States
Rx For Life, Inc
Cudahy, California, United States
Medical Group Of Encino
Encino, California, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Valley Research
Fresno, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
...and 64 more locations