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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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
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81
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Los Angeles, California 90057
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Chiefland, Florida 32626
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Pembroke Pines, Florida 33026
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6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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Akron, Ohio 44313
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Arlington, Texas 76012
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Battle Creek, Michigan 49015
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Beaver, Pennsylvania 15009
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Bellevue, Nebraska 68005
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Bennington, Vermont 05201
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Birmingham, Alabama 35209
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Blackwood, New Jersey 08012
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Bountiful, Utah 84010
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Bristol, Tennessee 37620
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Charlotte, North Carolina 28204
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Chicago, Illinois 60607
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Cincinnati, Ohio 45219
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Cleveland, Ohio 44122
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Colorado Springs, Colorado 80922
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Columbia, South Carolina 29204
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Coquitlam, British Columbia
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Coral Gables, Florida 33134
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Corpus Christi, Texas 78404
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Council Bluffs, Iowa 51503
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Dallas, TX
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Dayton, Ohio 45419
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Denver, Colorado 80211
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Denver, Colorado 80246
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Detroit, Michigan 48235
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Elizabeth, New Jersey 07205
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Elkhorn, Nebraska 68022
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Eugene, Oregon 97404
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Eunice, LA
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Florissant, Missouri 63031
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Fountain Inn, South Carolina 29644
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Fountain Valley, California 92708
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Fremont, Nebraska 68025
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Greensboro, North Carolina 27410
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Homewood, Alabama 35209
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Houston, Texas 77081
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Jacksonville, Florida 32216
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Kingsport, Tennessee 37660
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Lomita, California 90717
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Mesa, Arizona 85206
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Miami, Florida 33126
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Miami, Florida 33175
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Miami Beach, Florida 33140
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Morehead City, North Carolina 28557
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Muscle Shoals, Alabama 35662
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Norman, Oklahoma 73069
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North Hollywood, California 91606
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North Richland Hills, Texas 76180
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Northridge, California 91325
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Northridge, California 91325
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Norwalk, California 90650
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Omaha, Nebraska 68130
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Palm Harbor, Florida 34684
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Paramount, California 90723
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Roswell, Georgia 30076
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Sacramento, California 95823
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San Antoinio, Texas 78229
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West Seneca, New York 14224
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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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Zanesville, Ohio 43701
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