A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Overview
- Phase
- Phase 3
- Intervention
- Saxagliptin
- Conditions
- Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 365
- Locations
- 51
- Primary Endpoint
- Change From Baseline in Hemoglobin A1 (A1C) at Week 24
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
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 will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Inadequate blood sugar control
Exclusion Criteria
- •Previous treatment for diabetes
- •Current treatment with other medications to lower blood sugar
- •Major heart, liver or kidney problems
- •Women who are pregnant or breastfeeding
Arms & Interventions
Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
Intervention: Saxagliptin
Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
Intervention: Saxagliptin
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
Intervention: Saxagliptin
Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
Intervention: Saxagliptin
Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
Intervention: Placebo
Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Time Frame: Baseline, Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Secondary Outcomes
- 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)
- Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM(Baseline, Week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline, Week 24)