Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01619059
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to learn if BMS-477118 (Saxagliptin) 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Placebo+Dapagliflozin+Metformin IR Placebo matching with Saxagliptin - Arm 1: Saxagliptin+Dapagliflozin+Metformin IR Metformin IR - Arm 2: Placebo+Dapagliflozin+Metformin IR Metformin IR - Arm 1: Saxagliptin+Dapagliflozin+Metformin IR Saxagliptin - Arm 1: Saxagliptin+Dapagliflozin+Metformin IR Dapagliflozin - Arm 2: Placebo+Dapagliflozin+Metformin IR Dapagliflozin -
- 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. 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 at Week 24 in the double-blind period, including observations prior to rescue.
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 From Baseline to Week 24 Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) From Baseline to Week 24 Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 From Baseline to Week 24 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 at Week 24 in the double-blind period, including observations prior to rescue.
Trial Locations
- Locations (35)
Beach Physicians Clinical Research Corp.
🇺🇸Huntington Beach, California, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
Cassidy Medical Group/Clinical Research Advantage
🇺🇸Vista, California, United States
Infosphere Clinical Research, Inc.
🇺🇸West Hills, California, United States
New West Physicians, Pc
🇺🇸Golden, Colorado, United States
Southeast Clinical Research, Llc
🇺🇸Chiefland, Florida, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
University Of Florida Endocrinology & Diabetes
🇺🇸Jacksonville, Florida, United States
Care Partners Clinical Research, Llc
🇺🇸Jacksonville, Florida, United States
Clinical Research Advantage
🇺🇸Evansville, Indiana, United States
Mercy Health Research
🇺🇸Saint Louis, Missouri, United States
Joslin Diabetes Center Affiliate Of Snhmc
🇺🇸Nashua, New Hampshire, United States
N. Shore Diabetes & Endoc Assoc
🇺🇸New Hyde Park, New York, United States
Barat Research Group, Inc.
🇺🇸Charlotte, North Carolina, United States
Digiovanna Institute For Medical Education & Research
🇺🇸North Massapequa, New York, United States
Physicians Research, Inc.
🇺🇸Zanesville, Ohio, United States
Holston Medical Group
🇺🇸Bristol, Tennessee, United States
Local Institution
🇷🇺Yaroslaval, Russian Federation
Research & Cardiovascular Corp
🇵🇷Ponce, Puerto Rico
Clinical Research Advantage Inc/Desert Clinical Research Llc
🇺🇸Mesa, Arizona, United States
Family Medicine Of Sayebrook
🇺🇸Myrtle Beach, South Carolina, United States
Terence T. Hart, Md
🇺🇸Muscle Shoals, Alabama, United States
Mesa Family Medical Center
🇺🇸Mesa, Arizona, United States
Randall G. Shue, Do, Inc.
🇺🇸Los Angeles, California, United States
Sterling Research Grp, Ltd.
🇺🇸Cincinnati, Ohio, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Medical Research Unlimited, Llc
🇺🇸Hialeah, Florida, United States
Clinical Research Of Miami, Inc.
🇺🇸Miami, Florida, United States
Clinical Research Advantage, Inc.
🇺🇸Las Vegas, Nevada, United States
Tlm Medical Services
🇺🇸Columbia, South Carolina, United States
Padre Coast Clinical Research
🇺🇸Corpus Christi, Texas, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Clinical Research Advantage, Inc
🇺🇸Phoenix, Arizona, United States
Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc
🇺🇸Phoenix, Arizona, United States
Vanderbilt Diabetes Center
🇺🇸Nashville, Tennessee, United States