The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone
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 pioglitizone added onto their blinded study medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,462
Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline is adjusted for baseline value.
Time frame: Baseline, Week 24
Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Mean change from baseline is adjusted for baseline value.
Time frame: Baseline, Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
Time frame: Week 24
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
Mean change from baseline is adjusted for baseline value.
Time frame: Baseline, Week 24
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Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 15 - 45 mg (as needed for rescue)
Local Institution
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
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Haleyville, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Sherwood, Arkansas, United States
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Encino, California, United States
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