A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Overview
- Phase
- Phase 3
- Intervention
- Saxagliptin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- AstraZeneca
- Enrollment
- 1035
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c (A1C) Changes From Baseline at Week 24
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently 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 added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes mellitus
- •Drug naive
- •Hemoglobin (Hb) A1c \>= 7.0% and \<= 10.0% (\>10% and \<= 12% for open label arm)
- •Fasting C-peptide \>= 1 ng/mL
- •Body mass index \<= 40 kg/m2
Exclusion Criteria
- •Symptomatic poorly controlled diabetes
- •Recent cardiac or cerebrovascular event
- •Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for Women of Child Bearing Potential
Arms & Interventions
Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Saxagliptin
Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Placebo matching Metformin
Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Metformin
Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Saxagliptin
Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Placebo matching Metformin
Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Metformin
Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Saxagliptin
Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Placebo matching Metformin
Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Metformin
Placebo (D)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Placebo matching Saxagliptin
Placebo (D)
Metformin 500-2000 mg (as needed for rescue)
Intervention: Metformin
Open-Label Treatment Cohort (Direct Enrollees) (E)
Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Intervention: Saxagliptin
Open-Label Treatment Cohort (Direct Enrollees) (E)
Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Intervention: Metformin
Outcomes
Primary Outcomes
Hemoglobin A1c (A1C) Changes From Baseline at Week 24
Time Frame: Baseline, Week 24
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
A1C Changes From Baseline at Week 24 - Open Label Cohort
Time Frame: Baseline, Week 24
To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Secondary Outcomes
- Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)(Baseline, Week 24)
- Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24(Week 24)
- Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)(Baseline, Week 24)
- Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort(Baseline, Week 24)
- Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort(Week 24)
- Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort(Baseline, Week 24)