The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes
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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
768
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks 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 Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide 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 values.
Time frame: Baseline, Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Reserach Solutions, Llc
Jonesboro, Arkansas, United States
Searcy Medical Center
Searcy, Arkansas, United States
Stewart Medical Group
Alhambra, California, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Valley Research
Fresno, California, United States
Randall Shue, D.O.
Los Angeles, California, United States
Clinical Trials Research
Roseville, California, United States
New West Physicians
Golden, Colorado, United States
Phoenix Internal Medicine Associates, Llc
Waterbury, Connecticut, United States
Christiana Care Research Institute
Newark, Delaware, United States
...and 105 more locations