Study identifier:CV181-040
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Glyburide in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Glyburide Alone
diabetes
Phase 3
No
Saxagliptin, Glyburide, Placebo, Metformin
All
768
Interventional
18 Years - 77 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Franklin, OH, United States, 45005
Location
Kissimmee, FL, United States, 34741
Location
Roseville, CA, United States, 95661
Location
Eugene, OR, United States, 97401
Location
Carolina, Puerto Rico, 00983
Location
High Point, NC, United States, 27262
Location
Taylors, SC, United States, 29687
Location
Norristown, PA, United States, 19401
Arms | Assigned Interventions |
---|---|
Experimental: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) Metformin 500-2500 mg (as needed) | Drug: Saxagliptin Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT]) Other Name: BMS-477118 Drug: Glyburide Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT) |
Experimental: Saxagliptin 5 mg + Glyburide 7.5 mg (B) Metformin 500-2500 mg (as needed) | Drug: Saxagliptin Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). Other Name: BMS-477118 Drug: Glyburide Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT) |
Placebo Comparator: Placebo + Glyburide 7.5 mg (C) Metformin 500-2500 mg (as needed) | Drug: Placebo Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT) Drug: Glyburide 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) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT) |
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