Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2012
End Date:January 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
81
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Physicians Research, Inc
Zanesville, Ohio 43701
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Southeast Clinical Research, Llc
304 Northeast 1st Street
Chiefland, Florida 32626
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Andres Patron, DO, PA
Ste 205, 10796 Pines Boulevard
Pembroke Pines, Florida 33026
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Genova Clinical Research
6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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Daystar Clinical Resarch, Inc.
Akron, Ohio 44313
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Arlington Family Research Center
Arlington, Texas 76012
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Associated Internal Medicine Specialists, PC
Battle Creek, Michigan 49015
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Heritage Valley Medical Group
Beaver, Pennsylvania 15009
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Bellevue Family Practice
Bellevue, Nebraska 68005
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Southwestern Vermont Med Cntr
Bennington, Vermont 05201
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Central Alabama Research
Birmingham, Alabama 35209
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South Jersey Medical Associates, P.A.
Blackwood, New Jersey 08012
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Val R. Hansen, M.D.
Bountiful, Utah 84010
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Holston Medical Group
Bristol, Tennessee 37620
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Metrolina Internal Medicine
Charlotte, North Carolina 28204
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Cedar-Crosse Research Center
Chicago, Illinois 60607
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Sterling Research Grp, Ltd.
Cincinnati, Ohio 45219
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Rapid Medical Research, Inc.
Cleveland, Ohio 44122
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Clinical Research Advantage
Colorado Springs, Colorado 80922
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TLM Medical Services, LLC
Columbia, South Carolina 29204
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Local Institution
Coquitlam, British Columbia
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Clinical Therapeutics Corporation
Coral Gables, Florida 33134
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Padre Coast Clinical Research
Corpus Christi, Texas 78404
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Clinical Research Advantage
Council Bluffs, Iowa 51503
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Dallas Diabetes and Endocrine Center
Dallas, Texas 75230
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Primed Clinical Research
Dayton, Ohio 45419
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InFocus Clinical Research
Denver, Colorado 80211
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Lynn Institute of Denver
Denver, Colorado 80246
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Harris and Associates MD, PC
Detroit, Michigan 48235
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Central Jersey Health And Medical Research
Elizabeth, New Jersey 07205
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Elizabeth, NJ
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Clinical Research Advantage
Elkhorn, Nebraska 68022
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Willamette Valley Clinical Studies
Eugene, Oregon 97404
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Eugene, OR
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Horizon Research Group of Opelousas, LLC
Eunice, Louisiana 70535
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Patterson Medical Clinic
Florissant, Missouri 63031
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Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina 29644
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Southland Clinical Research Center, Inc.
Fountain Valley, California 92708
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Clinical Research Advantage
Fremont, Nebraska 68025
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Triad Clinical Trials, LLC
Greensboro, North Carolina 27410
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Central Alabama Research, LLC
Homewood, Alabama 35209
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Excel Clinical Research, Llc
Houston, Texas 77081
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Southeast Clinical Research, Llc
Jacksonville, Florida 32216
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Holston Medical Group, PC
Kingsport, Tennessee 37660
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Fpa Clinical Research
Kissimmee, Florida 34741
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PMG Research of Knoxville
Knoxville, Tennessee 37912
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Medical Investigations, Inc.
Little Rock, Arkansas 72205
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Aureus Research, Inc.
Little Rock, Arkansas 72211
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Torrance Clinical Research
Lomita, California 90717
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National Research Inst
Los Angeles, California 90057
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Clinical Research Advantage
Mesa, Arizona 85206
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Clinical Research Of Miami, Inc.
Miami, Florida 33126
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Advanced Pharma CR, LLC
Miami, Florida 33175
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Newphase Clinical Trials, Inc.
Miami Beach, Florida 33140
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Diabetes & Endocrinology Consultants
Morehead City, North Carolina 28557
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Terence T. Hart MD
Muscle Shoals, Alabama 35662
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Lynn Institute of Norman
Norman, Oklahoma 73069
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Providence Clinical Research
North Hollywood, California 91606
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North Hills Medical Research, Inc.
North Richland Hills, Texas 76180
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Mehrdad Kevin Ariani Md, Inc.
Northridge, California 91325
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Diabetes Medical Center Of California
Northridge, California 91325
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Lucita M. Cruz,Md.,Inc.
Norwalk, California 90650
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Clinical Research Advantage INC
Omaha, Nebraska 68130
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Omega Research Consultants, Llc
Orlando, Florida 32804
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International Institute Of Clinical Research
Ozark, Alabama 36360
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Palm Harbor Medical Associates
Palm Harbor, Florida 34684
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Center for Clinical Trials, LLC.
Paramount, California 90723
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Med-Olam Clinical Research
Pasadena, Texas 77504
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Elite Clinical Studies
Phoenix, Arizona 85018
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Oregon Clinical Research
Portland, Oregon 97220
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Endocrine Research Solutions, Inc.
Roswell, Georgia 30076
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Center for Clinical Trials of Sacramento, Inc.
Sacramento, California 95823
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Highland Clinical Research
Salt Lake City, Utah 84124
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Sam Clinical Research Center
San Antoinio, Texas 78229
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Covenant Clinical Research, Pa
San Antonio, Texas 78229
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Trinitas Research, Inc
San Jose, California 95116
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Wellmon Family Practice
Shippensburg, Pennsylvania 17257
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Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia 23435
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Orange County Research Center
Tustin, California
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Deerbrook Medical Associates
Vernon Hills, Illinois 60061
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Hillcrest Family Health Center
Waco, Texas 76710
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Southgate Medical Group
West Seneca, New York 14224
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PMG Research of Winston-Salem
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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