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
Overview
- Phase
- Phase 3
- Intervention
- Saxagliptin
- Conditions
- Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 768
- Locations
- 55
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (A1C) at Week 24
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 Diabetes.
- •Treated with a sulfonylurea for at least 2 months.
- •Inadequate blood sugar control.
- •Are not on any other medications to lower blood sugar.
- •No major heart, liver or kidney problems.
- •Women not pregnant or breast feeding.
Exclusion Criteria
- Not provided
Arms & Interventions
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
Intervention: Saxagliptin
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
Intervention: Glyburide
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
Intervention: Metformin
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
Intervention: Saxagliptin
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
Intervention: Glyburide
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
Intervention: Metformin
Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
Intervention: Placebo
Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
Intervention: Glyburide
Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
Intervention: Metformin
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Time Frame: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline, Week 24)
- Percentage of Participants Achieving A1C < 7% at Week 24(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(Baseline, Week 24)