The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD 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 metformin (defined as rescue medication) added onto their blinded study medication
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
565
Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)
Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
Change From Baseline in Hemoglobin A1c (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 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 Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD 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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
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Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Winston Technology, Inc.
Haleyville, Alabama, United States
Sunbelt Research Group, Llc
Mobile, Alabama, United States
Iicr, Inc.
Ozark, Alabama, United States
Clinical Research Advantage, Inc
Mesa, Arizona, United States
Nea Clinic
Jonesboro, Arkansas, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States
Impact Clinical Trials
Beverly Hills, California, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, United States
Medical Group Of Encino
Encino, California, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States
...and 123 more locations