Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01646320
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
- Detailed Description
Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Placebo + Saxagliptin + Metformin IR Metformin immediate release (IR) - Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR Saxagliptin - Arm 2: Placebo + Saxagliptin + Metformin IR Placebo matching with Dapagliflozin - Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR Metformin immediate release (IR) - Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR Dapagliflozin - Arm 2: Placebo + Saxagliptin + Metformin IR Saxagliptin -
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 From Baseline to Week 24 HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 From Baseline to Week 24 Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period
Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24 From Baseline to Week 24 2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.
Adjusted Mean Change From Baseline in Body Weight at Week 24 From baseline to Week 24 Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.
Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) From baseline to week 24 Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis.
Trial Locations
- Locations (28)
Torrance Clinical Research Institute Inc.
๐บ๐ธLomita, California, United States
Diabetes Medical Center Of California
๐บ๐ธNorthridge, California, United States
Cassidy Medical Group/Clinical Research Advantage
๐บ๐ธVista, California, United States
Palm Harbor Medical Associates
๐บ๐ธPalm Harbor, Florida, United States
Clinical Research Advantage
๐บ๐ธEvansville, Indiana, United States
Associated Internal Medicine Specialists
๐บ๐ธBattle Creek, Michigan, United States
Compass Research East, Llc
๐บ๐ธOviedo, Florida, United States
Jackson Clinic
๐บ๐ธRolling Fork, Mississippi, United States
Metrolina Internal Medicine
๐บ๐ธCharlotte, North Carolina, United States
Local Institution
๐ฌ๐งLondon, United Kingdom
Clinical Research Puerto Rico
๐ต๐ทSan Juan, Puerto Rico
Premier Research
๐บ๐ธTrenton, New Jersey, United States
Arkansas Clinical Research
๐บ๐ธLittle Rock, Arkansas, United States
Fpa Clinical Research
๐บ๐ธKissimmee, Florida, United States
University Of Alabama At Birmingham
๐บ๐ธBirmingham, Alabama, United States
Palm Springs Research Institute
๐บ๐ธHialeah, Florida, United States
Cedar Crosse Research Center
๐บ๐ธChicago, Illinois, United States
Sterling Research Grp, Ltd.
๐บ๐ธCincinnati, Ohio, United States
Endocrine Associates
๐บ๐ธHouston, Texas, United States
Sam Clinical Research Center
๐บ๐ธSan Antonio, Texas, United States
Tidewater Integrated Medical Research
๐บ๐ธVirginia Beach, Virginia, United States
Clinical Research Advantage Inc/Desert Clinical Research Llc
๐บ๐ธMesa, Arizona, United States
Clinical Research Advantage, Inc.
๐บ๐ธPhoenix, Arizona, United States
Elite Clinical Studies, Llc
๐บ๐ธPhoenix, Arizona, United States
Randall G. Shue, Do, Inc.
๐บ๐ธLos Angeles, California, United States
National Research Institute
๐บ๐ธLos Angeles, California, United States
International Research Associates, Llc
๐บ๐ธMiami, Florida, United States
Omega Research Consultants, Llc
๐บ๐ธOrlando, Florida, United States