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Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Saxagliptin (Drug); Dapagliflozin (Drug); Sitagliptin (Drug); Placebo matching with Saxagliptin (Drug); Placebo matching with Dapagliflozin (Drug); Placebo matching with Sitagliptin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

Summary

A combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Clinical Details

Official title: A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean change in HbA1c

Secondary outcome:

Percent of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%

Mean change in total body weight

Mean change in Fasting Plasma Glucose (FPG)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com Inclusion Criteria:

- Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control,

defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8. 0% and ≤ 10. 5 % obtained at the screening visit

- Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at

least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening

- BMI > 20. 0 kg/m2 at the enrollment visit

- Males and Females, age ≥18 years old at time of screening visit

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy

test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug

- Women must not be breastfeeding

Exclusion Criteria:

- Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes

of Young (MODY), secondary diabetes mellitus or diabetes insipidus

- History of diabetic ketoacidosis

- Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the

enrollment visit

- Myocardial infarction

- Cardiac surgery or revascularization (coronary artery bypass surgery Coronary

Artery Bypass Graft [(CABG)]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty [(PTCA)])

- Unstable angina

- Unstable congestive heart failure (CHF)

- Transient ischemic attack (TIA) or significant cerebrovascular disease

- Unstable or previously undiagnosed arrhythmia

- Congestive heart failure, defined as New York Heart Association (NYHA) Class III

and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%

- Renal Disease

- Hepatic Diseases

- Hematological and Oncological Disease/Conditions

- Hemoglobin ≤ 11. 0 g/dL (110 g/L) for men; hemoglobin ≤ 10. 0 g/dL (100 g/L) for women

- Abnormal Free T4

Locations and Contacts

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

Local Institution, Baja 6500, Hungary; Recruiting
Site 0068

Local Institution, Budapest 1036, Hungary; Recruiting
Site 0057

Local Institution, Budapest 1097, Hungary; Recruiting
Site 0051

Local Institution, Debrecen 4032, Hungary; Recruiting
Site 0069

Local Institution, Gyula 5700, Hungary; Recruiting
Site 0064

Local Institution, Nyiregyhaza 4405, Hungary; Recruiting
Site 0066

Local Institution, Szekszard 7100, Hungary; Recruiting
Site 0084

Local Institution, Zalaegerszeg 8900, Hungary; Not yet recruiting
Site 0009

Local Institution, Aguascalientes 20230, Mexico; Recruiting
Site 0045

Local Institution, Chihuahua 31217, Mexico; Recruiting
Site 0037

Local Institution, Distrito Federal 11550, Mexico; Recruiting
Site 0082

Local Institution, Bialystok 15-879, Poland; Recruiting
Site 0081

Local Institution, Krakow 30-015, Poland; Recruiting
Site 0036

Local Institution, Krakow 31-261, Poland; Recruiting
Site 0044

Local Institution, Lodz 90-132, Poland; Recruiting
Site 0070

Local Institution, Poznan 61-655, Poland; Recruiting
Site 0028

Local Institution, Warszawa 02-507, Poland; Recruiting
Site 0072

Local Institution, Wroclaw 50-349, Poland; Recruiting
Site 0030

Local Institution, Wroclaw 51-685, Poland; Recruiting
Site 0071

Local Institution, Brasov 500269, Romania; Not yet recruiting
Site 0038

Local Institution, Bucuresti 020359, Romania; Not yet recruiting
Site 0016

Local Institution, Bucuresti 020045, Romania; Not yet recruiting
Site 0015

Local Institution, Bucuresti 011794, Romania; Not yet recruiting
Site 0011

Local Institution, Buzau 120293, Romania; Not yet recruiting
Site 0029

Local Institution, Galati 800098, Romania; Not yet recruiting
Site 0012

Local Institution, Satu Mare 440055, Romania; Not yet recruiting
Site 0034

Local Institution, Boksburg 1460, South Africa; Recruiting
Site 0059

Local Institution, Cape Town 7500, South Africa; Recruiting
Site 0053

Local Institution, Johannesburg 1829, South Africa; Recruiting
Site 0061

Local Institution, Mpumalanga 1022, South Africa; Not yet recruiting
Site 0058

Local Institution, Soweto 1818, South Africa; Recruiting
Site 0060

Local Institution, Soweto 2013, South Africa; Recruiting
Site 0052

Clinical Research Advantage, Mesa, Arizona 85206, United States; Recruiting
Tami Bruce, Site 0090, Phone: 480-751-2491

Clinical Research Advantage/Desert Clinical Research, Mesa, Arizona 85213, United States; Recruiting
Gerald R Shockey, Site 0086, Phone: 480-305-5703

Clinical Research Advantage, Inc, Phoenix, Arizona 85020, United States; Recruiting
Ernie Riffer, Site 0023, Phone: 480-305-5703

Lynn Institute Of The Ozarks, Little Rock, Arkansas 72205, United States; Recruiting
Chrystal Johnson, Site 0073, Phone: 501-975-2000

Local Institution, Oradea, Bihor 410169, Romania; Not yet recruiting
Site 0033

Diabetes/Lipid Management And Research Center, Huntington Beach, California 92648, United States; Recruiting
Paul D Rosenblit, Site 0095, Phone: 714-375-7386

Del Rosario Medical Clinic, Inc., Huntington Park, California 90255, United States; Recruiting
Graciela Calatayud, Site 0008, Phone: 323-589-9384

Scripps Clinic Medical Group, Inc, La Jolla, California 92037, United States; Recruiting
Athena Philis-Tsimikas, Site 0094, Phone: 858-453-0753

Torrance Clinical Research Institute Inc., Lomita, California 90717, United States; Recruiting
Marina Raikhel, Site 0048, Phone: 208-346-8900

National Research Institute, Los Angeles, California 90057, United States; Recruiting
Juan Frias, Site 0020, Phone: 213-483-1800

Diabetes Medical Center Of California, Northridge, California 91325, United States; Recruiting
Gholamreza Bonabi, Site 0091, Phone: 818-368-4212

Lucita M. Cruz,Md.,Inc., Norwalk, California 90650, United States; Active, not recruiting

Center For Clinical Trials, Llc., Paramount, California 90723, United States; Recruiting
Jose Mari Elacion, Site 0002, Phone: 562-633-5101

Center For Clinical Trials Of Sacramento, Inc., Sacramento, California 95823, United States; Recruiting
Rebecca Jordan, Site 0003, Phone: 916-525-3377

Metabolic Institute Of America, Tarzana, California 91356, United States; Recruiting
Yehuda Handelsman, Site 0093, Phone: 818-708-9942

Orange County Research Center, Tustin, California 92780, United States; Recruiting
Joel M Neutel, Site 0046, Phone: 714-550-1226

New West Physicians, Pc, Golden, Colorado 80401, United States; Recruiting
Kenneth Cohen, Site 0089, Phone: 303-785-5992

Local Institution, Craiova, Doij 200349, Romania; Not yet recruiting
Site 0013

Clinical Therapeutics Corporation, Coral Gables, Florida 33134, United States; Recruiting
Baudilio Cusco-Prieto, Site 0018, Phone: 305-444-9356

The Chappel Group, Kissimmee, Florida 34744, United States; Recruiting
Christopher M Chappel, Site 0007, Phone: 844-362-2427

Newphase Clinical Trials, Inc., Miami Beach, Florida 33140, United States; Recruiting
Pablo Canino, Site 0063, Phone: 305-858-4300

Dr. De Armas Research Center, Llc, Miami, Florida 33174, United States; Recruiting
Luis De Armas, Site 0042, Phone: 305-503-2903

San Marcus Research Clinic, Inc., Miami, Florida 33015, United States; Recruiting
Belkis Delgado, Site 0019, Phone: 305-424-7420

Suncoast Research Group, Llc, Miami, Florida 33135, United States; Recruiting
Mark Kutner, Site 0087, Phone: 305-631-6704

Medical Research Group Of Central Florida, Orange City, Florida 32763, United States; Recruiting
Josette Romain, Site 0080, Phone: 407-330-2262

Palm Harbor Medical Associates, Palm Harbor, Florida 34684, United States; Recruiting
Aron Schlau, Site 0005, Phone: 727-785-4540, Ext: 112

Andres Patron, Do Pa, Pembroke Pines, Florida 33026, United States; Recruiting
Andres Patron, Site 0022, Phone: 972-566-7799

Advanced Clinical Research, Meridian, Idaho 83642, United States; Recruiting
Mark Turner, Site 0049, Phone: 208-377-8653

Chicago Research Center, Chicago, Illinois 60634, United States; Recruiting
Mimi Van Der Leden, Site 0039, Phone: 773-282-9845

Clinical Research Advantage, Council Bluffs, Iowa 51503, United States; Recruiting
Jennifer Kay, Site 0041, Phone: 480-305-5703

Local Institution, Guadalajara, Jalisco 44130, Mexico; Recruiting
Site 0078

Local Institution, Guadalajara, Jalisco 44160, Mexico; Recruiting
Site 0056

Local Institution, Guadalajara, Jalisco 44670, Mexico; Recruiting
Site 0055

Cti Clinical Research Center, Crestview Hills, Kentucky 41017, United States; Recruiting
Robert Wagner, Site 0077, Phone: 513-272-9740

Local Institution, Durban, Kwa-Zulu Natal 4091, South Africa; Recruiting
Site 0062

Horizon Research Group Of Opelousas, Llc, Eunice, Louisiana 70535, United States; Recruiting
Randall Miller, Site 0076, Phone: 337-550-8300

Local Institution, Cuautla, Morelos 62746, Mexico; Recruiting
Site 0079

Metrolina Internal Medicine, Charlotte, North Carolina 28204, United States; Recruiting
Karlton Pettis, Site 0047, Phone: 704-374-0030

Diabetes & Endocrinology Consultants, Morehead City, North Carolina 28557, United States; Recruiting
Kathryn Lucas, Site 0040, Phone: 252-222-5700

Pmg Research Of Salisbury, Salisbury, North Carolina 28144, United States; Recruiting
Robert Eric Mcneill, Site 0075, Phone: 704-647-9913

Local Institution, Monterrey, Nuevo Leon 64460, Mexico; Recruiting
Site 0083

Lion Research, Norman, Oklahoma 73069, United States; Recruiting
Lisa Connery, Site 0017, Phone: 405-701-2866

Local Institution, Gdansk, Pomorskie 80-546, Poland; Recruiting
Site 0043

Tlm Medical Services, Columbia, South Carolina 29204, United States; Recruiting
Conigliaro Jones, Site 0074, Phone: 803-376-8875

Holston Medical Group, Bristol, Tennessee 37620, United States; Recruiting
Rick J Whiles, Site 0006, Phone: 423-578-1546

Dallas Diabetes & Endocrine Center, Dallas, Texas 75230, United States; Recruiting
Julio Rosenstock, Site 0024, Phone: 972-566-7799

Tcv Clinical Research, Gonzales, Texas 78629, United States; Recruiting
Garth Vaz, Site 0092, Phone: 830-672-2424

Texas Center For Drug Development, Houston, Texas 77081, United States; Recruiting
Veronica Fragoso, Site 0027, Phone: 713-838-2022

North Hills Medical Research, Inc., North Richland Hills, Texas 76180, United States; Recruiting
John D Gabriel, Site 0032, Phone: 208-346-8900

Med-Olam Clinical Research, Pasadena, Texas 77504, United States; Recruiting
Gordon Sack, Site 0025, Phone: 713-941-7788

Clinical Trials Of Texas Inc., San Antonio, Texas 78229, United States; Recruiting
Douglas Denham, Site 0088, Phone: 210-949-0122

Covenant Clinical Research, Pa, San Antonio, Texas 78229, United States; Recruiting
Ronald K Garcia, Site 0021, Phone: 210-614-3030

S.A.M. Clinical Research Center, San Antonio, Texas 78229, United States; Recruiting
Sam Miller, Site 0004, Phone: 210-614-4800

Local Institution, Timisoara, Timis 300736, Romania; Not yet recruiting
Site 0014

Manassas Clinical Research Center, Manasses, Virginia 20110, United States; Recruiting
Nabil Andrawis, Site 0031, Phone: 817-595-3399

Hampton Roads Center For Clinical Research, Inc., Suffolk, Virginia 23435, United States; Recruiting
David Scott Ramstad, Site 0026, Phone: 757-394-1390

Local Institution, Rondebosch, Western Cape 7700, South Africa; Recruiting
Site 0054

Clinical Investigation Specialists, Inc., Kenosha, Wisconsin 53142, United States; Recruiting
John M Agaiby, Site 0085, Phone: 262-925-1280

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: December 2014
Last updated: August 19, 2015

Page last updated: August 23, 2015

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