Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01606007
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1282
- Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
- Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
- Body mass index (BMI) ≤ 45.0kg/m2
- Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
- Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
- Hepatic disease
- Cardiovascular disease within 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Dapagliflozin+Metformin XR+Placebo Placebo matching with Saxagliptin - Arm 3: Saxagliptin+Dapagliflozin+Metformin XR Saxagliptin - Arm 1: Saxagliptin+Metformin XR+Placebo Metformin XR - Arm 1: Saxagliptin+Metformin XR+Placebo Placebo matching with Dapagliflozin - Arm 2: Dapagliflozin+Metformin XR+Placebo Metformin XR - Arm 3: Saxagliptin+Dapagliflozin+Metformin XR Metformin XR - Arm 1: Saxagliptin+Metformin XR+Placebo Saxagliptin - Arm 2: Dapagliflozin+Metformin XR+Placebo Dapagliflozin - Arm 3: Saxagliptin+Dapagliflozin+Metformin XR Dapagliflozin -
- Primary Outcome Measures
Name Time Method Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 Baseline (Week 0) and at 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 Fasting Plasma Glucose (FPG) at Week 24 Baseline (Week 0) and at 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 doubleblind period, including observations prior to rescue.
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) At 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 Body Weight at Week 24 Baseline (Week 0) and at 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. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.
Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF]) Baseline (Week 0) and at 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 doubleblind period, including observations prior to rescue.
Trial Locations
- Locations (73)
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Pmg Research Of Knoxville
🇺🇸Knoxville, Tennessee, United States
Excel Clinical Research, Llc
🇺🇸Houston, Texas, United States
Covenant Clinical Research, Pa
🇺🇸San Antonio, Texas, United States
Metrolina Internal Medicine
🇺🇸Charlotte, North Carolina, United States
Diabetes & Endocrinology Consultants
🇺🇸Morehead City, North Carolina, United States
Sterling Research Grp, Ltd.
🇺🇸Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Arlington Family Research Center, Inc.
🇺🇸Arlington, Texas, United States
Med-Olam Clinical Research
🇺🇸Pasadena, Texas, United States
Terence T. Hart, Md
🇺🇸Muscle Shoals, Alabama, United States
Mehrdad Kevin Ariani Md, Inc.
🇺🇸Northridge, California, United States
Fpa Clinical Research
🇺🇸Kissimmee, Florida, United States
Associated Internal Medicine Specialists
🇺🇸Battle Creek, Michigan, United States
Central Jersey Health And Medical Research
🇺🇸Elizabeth, New Jersey, United States
Bellevue Family Practice
🇺🇸Bellevue, Nebraska, United States
South Jersey Medical Associates, P.A.
🇺🇸Blackwood, New Jersey, United States
Southgate Medical Group
🇺🇸West Seneca, New York, United States
Triad Clinical Trials, Llc
🇺🇸Greensboro, North Carolina, United States
Daystar Clinical Resarch, Inc.
🇺🇸Akron, Ohio, United States
Lynn Institute Of Norman
🇺🇸Norman, Oklahoma, United States
Primed Clinical Research
🇺🇸Dayton, Ohio, United States
Physicians Research, Inc.
🇺🇸Zanesville, Ohio, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Heritage Valley Medical Group
🇺🇸Beaver, Pennsylvania, United States
Wellmon Family Practice
🇺🇸Shippensburg, Pennsylvania, United States
Padre Coast Clinical Research
🇺🇸Corpus Christi, Texas, United States
Dallas Diabetes & Endocrine Center
🇺🇸Dallas, Texas, United States
North Hills Medical Research, Inc.
🇺🇸North Richland Hills, Texas, United States
Sam Clinical Research Center
🇺🇸San Antoinio, Texas, United States
Elite Clinical Studies, Llc
🇺🇸Phoenix, Arizona, United States
Harris And Associates, P.C.
🇺🇸Detroit, Michigan, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Trinitas Research, Inc
🇺🇸San Jose, California, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Aureus Research, Inc.
🇺🇸Little Rock, Arkansas, United States
Diabetes Medical Center Of California
🇺🇸Northridge, California, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Clinical Research Advantage
🇺🇸Omaha, Nebraska, United States
Infocus Clinical Research
🇺🇸Denver, Colorado, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Central Alabama Research
🇺🇸Homewood, Alabama, United States
Medical Investigations, Inc.
🇺🇸Little Rock, Arkansas, United States
Southeast Clinical Research, Llc
🇺🇸Jacksonville, Florida, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
International Institute Of Clinical Research
🇺🇸Ozark, Alabama, United States
Southland Clinical Research Center, Inc.
🇺🇸Fountain Valley, California, United States
National Research Inst
🇺🇸Los Angeles, California, United States
Advanced Pharma Cr, Llc
🇺🇸Miami, Florida, United States
Center For Clinical Trials, Llc.
🇺🇸Paramount, California, United States
Horizon Research Group Of Opelousas, Llc
🇺🇸Eunice, Louisiana, United States
Lynn Institute Of Denver
🇺🇸Denver, Colorado, United States
Lucita M. Cruz,Md.,Inc.
🇺🇸Norwalk, California, United States
Clinical Therapeutics Corporation
🇺🇸Coral Gables, Florida, United States
Newphase Clinical Trials, Inc.
🇺🇸Miami Beach, Florida, United States
Clinical Research Of Miami, Inc.
🇺🇸Miami, Florida, United States
Deerbrook Medical Associates
🇺🇸Vernon Hills, Illinois, United States
Patterson Medical Clinic
🇺🇸Florissant, Missouri, United States
Andres Patron, Do Pa
🇺🇸Pembroke Pines, Florida, United States
Oregon Clinical Research
🇺🇸Portland, Oregon, United States
Tlm Medical Services
🇺🇸Columbia, South Carolina, United States
Palmetto Clinical Trial Services Llc
🇺🇸Fountain Inn, South Carolina, United States
Southwestern Vermont Med Cntr
🇺🇸Bennington, Vermont, United States
Local Institution
🇿🇦Johannesburg, South Africa
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
Pmg Research Of Winston-Salem, Llc
🇺🇸Winston-salem, North Carolina, United States
Center For Clinical Trials Of Sacramento, Inc.
🇺🇸Sacramento, California, United States
Omega Research Consultants, Llc
🇺🇸Orlando, Florida, United States
Val R. Hansen, M.D.
🇺🇸Bountiful, Utah, United States
Hampton Roads Center For Clinical Research, Inc.
🇺🇸Suffolk, Virginia, United States