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.
๐บ๐ธHuntington Beach, California, United States
Torrance Clinical Research
๐บ๐ธLomita, California, United States
Cassidy Medical Group/Clinical Research Advantage
๐บ๐ธVista, California, United States
Infosphere Clinical Research, Inc.
๐บ๐ธWest Hills, California, United States
New West Physicians, Pc
๐บ๐ธGolden, Colorado, United States
Southeast Clinical Research, Llc
๐บ๐ธChiefland, Florida, United States
Clinical Therapeutics Corporation
๐บ๐ธCoral Gables, Florida, United States
University Of Florida Endocrinology & Diabetes
๐บ๐ธJacksonville, Florida, United States
Care Partners Clinical Research, Llc
๐บ๐ธJacksonville, Florida, United States
Clinical Research Advantage
๐บ๐ธEvansville, Indiana, United States
Mercy Health Research
๐บ๐ธSaint Louis, Missouri, United States
Joslin Diabetes Center Affiliate Of Snhmc
๐บ๐ธNashua, New Hampshire, United States
N. Shore Diabetes & Endoc Assoc
๐บ๐ธNew Hyde Park, New York, United States
Barat Research Group, Inc.
๐บ๐ธCharlotte, North Carolina, United States
Digiovanna Institute For Medical Education & Research
๐บ๐ธNorth Massapequa, New York, United States
Physicians Research, Inc.
๐บ๐ธZanesville, Ohio, United States
Holston Medical Group
๐บ๐ธBristol, Tennessee, United States
Local Institution
๐ท๐บYaroslaval, Russian Federation
Research & Cardiovascular Corp
๐ต๐ทPonce, Puerto Rico
Clinical Research Advantage Inc/Desert Clinical Research Llc
๐บ๐ธMesa, Arizona, United States
Family Medicine Of Sayebrook
๐บ๐ธMyrtle Beach, South Carolina, United States
Terence T. Hart, Md
๐บ๐ธMuscle Shoals, Alabama, United States
Mesa Family Medical Center
๐บ๐ธMesa, Arizona, United States
Randall G. Shue, Do, Inc.
๐บ๐ธLos Angeles, California, United States
Sterling Research Grp, Ltd.
๐บ๐ธCincinnati, Ohio, United States
National Research Institute
๐บ๐ธLos Angeles, California, United States
Medical Research Unlimited, Llc
๐บ๐ธHialeah, Florida, United States
Clinical Research Of Miami, Inc.
๐บ๐ธMiami, Florida, United States
Clinical Research Advantage, Inc.
๐บ๐ธLas Vegas, Nevada, United States
Tlm Medical Services
๐บ๐ธColumbia, South Carolina, United States
Padre Coast Clinical Research
๐บ๐ธCorpus Christi, Texas, United States
University Of Alabama At Birmingham
๐บ๐ธBirmingham, Alabama, United States
Clinical Research Advantage, Inc
๐บ๐ธPhoenix, Arizona, United States
Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc
๐บ๐ธPhoenix, Arizona, United States
Vanderbilt Diabetes Center
๐บ๐ธNashville, Tennessee, United States