Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.
2 other identifiers
interventional
1,282
8 countries
139
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Jul 2012
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
October 20, 2015
CompletedMay 15, 2017
March 1, 2017
1.5 years
May 23, 2012
December 19, 2014
March 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) 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.
Baseline (Week 0) and at Week 24
Secondary Outcomes (4)
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
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline (Week 0) and at Week 24
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
Adjusted Mean Change From Baseline in Body Weight at Week 24
Baseline (Week 0) and at Week 24
Study Arms (3)
Arm 1: Saxagliptin+Metformin XR+Placebo
ACTIVE COMPARATORArm 2: Dapagliflozin+Metformin XR+Placebo
ACTIVE COMPARATORArm 3: Saxagliptin+Dapagliflozin+Metformin XR
EXPERIMENTALInterventions
Tablets, Oral, 5mg , Once daily, 24 weeks
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Tablets, Oral, 10mg , Once daily, 24 weeks
Tablets, Oral, 0mg, Once daily, 24 weeks
Tablets, Oral, 0mg, Once daily, 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (139)
Central Alabama Research
Birmingham, Alabama, 35209, United States
Central Alabama Research
Homewood, Alabama, 35244, United States
Terence T. Hart, Md
Muscle Shoals, Alabama, 35662, United States
International Institute Of Clinical Research
Ozark, Alabama, 36360, United States
Clinical Research Advantage
Mesa, Arizona, 85206, United States
Elite Clinical Studies, Llc
Phoenix, Arizona, 85018, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Medical Investigations, Inc.
Little Rock, Arkansas, 72205, United States
Aureus Research, Inc.
Little Rock, Arkansas, 72211, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708, United States
Torrance Clinical Research
Lomita, California, 90717, United States
National Research Inst
Los Angeles, California, 90057, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Diabetes Medical Center Of California
Northridge, California, 91325, United States
Mehrdad Kevin Ariani Md, Inc.
Northridge, California, 91325, United States
Lucita M. Cruz,Md.,Inc.
Norwalk, California, 90650, United States
Center For Clinical Trials, Llc.
Paramount, California, 90723, United States
Center For Clinical Trials Of Sacramento, Inc.
Sacramento, California, 95823, United States
Trinitas Research, Inc
San Jose, California, 95116, United States
Orange County Research Center
Tustin, California, 92780, United States
Clinical Research Advantage
Colorado Springs, Colorado, 80906, United States
Infocus Clinical Research
Denver, Colorado, 80211, United States
Lynn Institute Of Denver
Denver, Colorado, 80246, United States
Southeast Clinical Research, Llc
Chiefland, Florida, 32626, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134, United States
Southeast Clinical Research, Llc
Jacksonville, Florida, 32216, United States
Fpa Clinical Research
Kissimmee, Florida, 34741, United States
Clinical Research Of Miami, Inc.
Miami, Florida, 33126, United States
Advanced Pharma Cr, Llc
Miami, Florida, 33136, United States
Newphase Clinical Trials, Inc.
Miami Beach, Florida, 33140, United States
Omega Research Consultants, Llc
Orlando, Florida, 32804, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684, United States
Andres Patron, Do Pa
Pembroke Pines, Florida, 33026, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607-4559, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061, United States
Clinical Research Advantage
Council Bluffs, Iowa, 51503, United States
Horizon Research Group Of Opelousas, Llc
Eunice, Louisiana, 70535, United States
Associated Internal Medicine Specialists
Battle Creek, Michigan, 49015, United States
Harris And Associates, P.C.
Detroit, Michigan, 48235, United States
Patterson Medical Clinic
Florissant, Missouri, 63031, United States
Bellevue Family Practice
Bellevue, Nebraska, 68005, United States
Clinical Research Advantage
Elkhorn, Nebraska, 68022, United States
Clinical Research Advantage
Fremont, Nebraska, 68025, United States
Clinical Research Advantage
Omaha, Nebraska, 68130, United States
South Jersey Medical Associates, P.A.
Blackwood, New Jersey, 08012, United States
Central Jersey Health And Medical Research
Elizabeth, New Jersey, 07205, United States
Southgate Medical Group
West Seneca, New York, 14224, United States
Metrolina Internal Medicine
Charlotte, North Carolina, 28204, United States
Triad Clinical Trials, Llc
Greensboro, North Carolina, 27410, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, 28557, United States
Pmg Research Of Winston-Salem, Llc
Winston-Salem, North Carolina, 27103, United States
Daystar Clinical Resarch, Inc.
Akron, Ohio, 44313, United States
Sterling Research Grp, Ltd.
Cincinnati, Ohio, 45246, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Primed Clinical Research
Dayton, Ohio, 45419, United States
Physicians Research, Inc.
Zanesville, Ohio, 43701, United States
Lynn Institute Of Norman
Norman, Oklahoma, 73069, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Oregon Clinical Research
Portland, Oregon, 97220, United States
Heritage Valley Medical Group
Beaver, Pennsylvania, 15009, United States
Wellmon Family Practice
Shippensburg, Pennsylvania, 17257, United States
Tlm Medical Services
Columbia, South Carolina, 29204, United States
Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina, 29644, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Pmg Research Of Knoxville
Knoxville, Tennessee, 37912, United States
Arlington Family Research Center, Inc.
Arlington, Texas, 76012, United States
Padre Coast Clinical Research
Corpus Christi, Texas, 78404, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230-2548, United States
Excel Clinical Research, Llc
Houston, Texas, 77035, United States
North Hills Medical Research, Inc.
North Richland Hills, Texas, 76180, United States
Med-Olam Clinical Research
Pasadena, Texas, 77504, United States
Sam Clinical Research Center
San Antoinio, Texas, 78229, United States
Covenant Clinical Research, Pa
San Antonio, Texas, 78229, United States
Hillcrest Family Health Center
Waco, Texas, 76710, United States
Val R. Hansen, M.D.
Bountiful, Utah, 84010, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Southwestern Vermont Med Cntr
Bennington, Vermont, 05201, United States
Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, 23435, United States
Local Institution
Coquitlam, British Columbia, V3K 3V9, Canada
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Winnipeg, Manitoba, R3E3P4, Canada
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Brampton, Ontario, L6T 0G1, Canada
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Smiths Falls, Ontario, K7A 4W8, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Québec, Quebec, G1N 4V3, Canada
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Saskatoon, Saskatchewan, S7K 3H3, Canada
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Aguascalientes, Aguascalientes, 20230, Mexico
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Chihuahua City, Chihuahua, 31217, Mexico
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Durango, Durango, 34000, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Cuautla, Morelos, 62744, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Monterrey, Nuevo León, 64710, Mexico
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Mérida, Yucatán, 97070, Mexico
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Gdansk, 80-546, Poland
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Katowice, 40-057, Poland
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Katowice, 40954, Poland
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Krakow, 30-015, Poland
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Lodz, 90-242, Poland
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Opole, 45-367, Poland
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Poznan, 61-655, Poland
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Puławy, 24-100, Poland
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Warsaw, 03-580, Poland
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Cidra, 00739, Puerto Rico
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Manatí, 00674, Puerto Rico
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Ponce, 00716, Puerto Rico
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San Juan, 00909, Puerto Rico
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San Juan, 00926, Puerto Rico
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San Juan, 00935, Puerto Rico
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Villa Fontana, 00983, Puerto Rico
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Galati, Galați County, 800098, Romania
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Ploieşti, Prahova, 100018, Romania
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Ploieşti, Prahova, 100163, Romania
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Timișoara, Timiș County, 300736, Romania
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Bucharest, 020359, Romania
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Bucharest, 020475, Romania
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Bucharest, 050538, Romania
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Bucharest, 11794, Romania
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Cluj Napoca Cluj, 400006, Romania
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Craiova, 200349, Romania
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Soweto, Gauteng, 2013, South Africa
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Gauteng, Johannesburg, 1818, South Africa
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Johannesburg, Johannesburg, 2129, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Cape Town, Western Cape, 7500, South Africa
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Goodwood, Western Cape, 7460, South Africa
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Paarl, Western Cape, 7646, South Africa
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Rondebosch, Western Cape, 7700, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Johannesburg, 1829, South Africa
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Bucheon-si, Gyeonggi-do, 420-717, South Korea
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Sungnam-si, Gyeonggi-do, 463-712, South Korea
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Daegu, 700-721, South Korea
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Incheon, 405-760, South Korea
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Seoul, 110-774, South Korea
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Seoul, 120-752, South Korea
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Seoul, 137-701, South Korea
Related Publications (3)
Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B, Iqbal N. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015 Mar;38(3):376-83. doi: 10.2337/dc14-1142. Epub 2014 Oct 28.
PMID: 25352655RESULTBailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
PMID: 31364269DERIVEDRosenstock J, Mathieu C, Chen H, Garcia-Sanchez R, Saraiva GL. Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. Arch Endocrinol Metab. 2018 Aug;62(4):424-430. doi: 10.20945/2359-3997000000056.
PMID: 30304106DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirshberg
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 25, 2012
Study Start
July 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 15, 2017
Results First Posted
October 20, 2015
Record last verified: 2017-03