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
-
No locations available
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) |