A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
Overview
- Phase
- Phase 3
- Intervention
- Saxagliptin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- AstraZeneca
- Enrollment
- 565
- Locations
- 80
- 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 clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
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 (defined as rescue medication) added onto their blinded study medication
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
- •Hemoglobin A1c (HbA1c) \> = 7.0% and \< = 10.5%
- •Body mass index \< = 45kg/m2
- •Fasting C-peptide \> = 1 ng/mL
Exclusion Criteria
- •Symptomatic poorly controlled diabetes
- •Recent cardiac or cerebrovascular event
- •Serum creatinine \> = 2.0 mg/dL
Arms & Interventions
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: Saxagliptin
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: pioglitazone
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: rosiglitazone
Saxagliptin plus open-label TZD (A)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: Saxagliptin
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: pioglitazone
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: rosiglitazone
Saxagliptin plus open-label TZD (B)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: metformin
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: Placebo
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: pioglitazone
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Intervention: rosiglitazone
Placebo plus open-label TZD (C)
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
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)