Back to resultsSafety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Saxagliptin
Metformin XR
Dapagliflozin
Placebo matching with Dapagliflozin
Placebo matching with Saxagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Central Alabama Research
- Central Alabama Research
- Terence T. Hart, Md
- International Institute Of Clinical Research
- Clinical Research Advantage
- Elite Clinical Studies, Llc
- Genova Clinical Research
- Medical Investigations, Inc.
- Aureus Research, Inc.
- Southland Clinical Research Center, Inc.
- Torrance Clinical Research
- National Research Inst
- Providence Clinical Research
- Diabetes Medical Center Of California
- Mehrdad Kevin Ariani Md, Inc.
- Lucita M. Cruz,Md.,Inc.
- Center For Clinical Trials, Llc.
- Center For Clinical Trials Of Sacramento, Inc.
- Trinitas Research, Inc
- Orange County Research Center
- Clinical Research Advantage
- Infocus Clinical Research
- Lynn Institute Of Denver
- Southeast Clinical Research, Llc
- Clinical Therapeutics Corporation
- Southeast Clinical Research, Llc
- Fpa Clinical Research
- Newphase Clinical Trials, Inc.
- Clinical Research Of Miami, Inc.
- Advanced Pharma Cr, Llc
- Omega Research Consultants, Llc
- Palm Harbor Medical Associates
- Andres Patron, Do Pa
- Endocrine Research Solutions, Inc.
- Cedar Crosse Research Center
- Deerbrook Medical Associates
- Clinical Research Advantage
- Horizon Research Group Of Opelousas, Llc
- Associated Internal Medicine Specialists
- Harris And Associates, P.C.
- Patterson Medical Clinic
- Bellevue Family Practice
- Clinical Research Advantage
- Clinical Research Advantage
- Clinical Research Advantage
- South Jersey Medical Associates, P.A.
- Central Jersey Health And Medical Research
- Southgate Medical Group
- Metrolina Internal Medicine
- Triad Clinical Trials, Llc
- Diabetes & Endocrinology Consultants
- Pmg Research Of Winston-Salem, Llc
- Daystar Clinical Resarch, Inc.
- Sterling Research Grp, Ltd.
- Rapid Medical Research, Inc.
- Primed Clinical Research
- Physicians Research, Inc.
- Lynn Institute Of Norman
- Willamette Valley Clinical Studies
- Oregon Clinical Research
- Heritage Valley Medical Group
- Wellmon Family Practice
- Tlm Medical Services
- Palmetto Clinical Trial Services Llc
- Holston Medical Group
- Holston Medical Group
- Pmg Research Of Knoxville
- Arlington Family Research Center, Inc.
- Padre Coast Clinical Research
- Dallas Diabetes & Endocrine Center
- Excel Clinical Research, Llc
- North Hills Medical Research, Inc.
- Med-Olam Clinical Research
- Sam Clinical Research Center
- Covenant Clinical Research, Pa
- Hillcrest Family Health Center
- Val R. Hansen, M.D.
- Highland Clinical Research
- Southwestern Vermont Med Cntr
- Hampton Roads Center For Clinical Research, Inc.
- Local Institution
- Local Institution
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Arm 1: Saxagliptin+Metformin XR+Placebo
Arm 2: Dapagliflozin+Metformin XR+Placebo
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) 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])
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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01606007
Brief Title
Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Saxagliptin+Metformin XR+Placebo
Arm Type
Active Comparator
Arm Title
Arm 2: Dapagliflozin+Metformin XR+Placebo
Arm Type
Active Comparator
Arm Title
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
Tablets, Oral, 5mg , Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin XR
Other Intervention Name(s)
Glucophage XR
Intervention Description
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
BMS-512148
Intervention Description
Tablets, Oral, 10mg , Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching with Dapagliflozin
Intervention Description
Tablets, Oral, 0mg, Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching with Saxagliptin
Intervention Description
Tablets, Oral, 0mg, Once daily, 24 weeks
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
Description
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.
Time Frame
Baseline (Week 0) and at Week 24
Secondary Outcome Measure Information:
Title
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])
Description
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.
Time Frame
Baseline (Week 0) and at Week 24
Title
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Description
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.
Time Frame
Baseline (Week 0) and at Week 24
Title
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Description
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.
Time Frame
At Week 24
Title
Adjusted Mean Change From Baseline in Body Weight at Week 24
Description
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.
Time Frame
Baseline (Week 0) and at Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Central Alabama Research
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Terence T. Hart, Md
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
International Institute Of Clinical Research
City
Ozark
State/Province
Alabama
ZIP/Postal Code
36360
Country
United States
Facility Name
Clinical Research Advantage
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Elite Clinical Studies, Llc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Medical Investigations, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Aureus Research, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Southland Clinical Research Center, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Torrance Clinical Research
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
National Research Inst
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Diabetes Medical Center Of California
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Mehrdad Kevin Ariani Md, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Lucita M. Cruz,Md.,Inc.
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Center For Clinical Trials, Llc.
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Center For Clinical Trials Of Sacramento, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Trinitas Research, Inc
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Clinical Research Advantage
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Infocus Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Lynn Institute Of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Southeast Clinical Research, Llc
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Clinical Therapeutics Corporation
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Southeast Clinical Research, Llc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Fpa Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Newphase Clinical Trials, Inc.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Clinical Research Of Miami, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Advanced Pharma Cr, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Omega Research Consultants, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Palm Harbor Medical Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Andres Patron, Do Pa
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607-4559
Country
United States
Facility Name
Deerbrook Medical Associates
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Clinical Research Advantage
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Horizon Research Group Of Opelousas, Llc
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Associated Internal Medicine Specialists
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
Facility Name
Harris And Associates, P.C.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Patterson Medical Clinic
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Bellevue Family Practice
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Clinical Research Advantage
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Clinical Research Advantage
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Clinical Research Advantage
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
South Jersey Medical Associates, P.A.
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
Central Jersey Health And Medical Research
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07205
Country
United States
Facility Name
Southgate Medical Group
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Metrolina Internal Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Triad Clinical Trials, Llc
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Diabetes & Endocrinology Consultants
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Pmg Research Of Winston-Salem, Llc
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Daystar Clinical Resarch, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
Facility Name
Sterling Research Grp, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Primed Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Physicians Research, Inc.
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Lynn Institute Of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Oregon Clinical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Heritage Valley Medical Group
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Wellmon Family Practice
City
Shippensburg
State/Province
Pennsylvania
ZIP/Postal Code
17257
Country
United States
Facility Name
Tlm Medical Services
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Palmetto Clinical Trial Services Llc
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Pmg Research Of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Arlington Family Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Padre Coast Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-2548
Country
United States
Facility Name
Excel Clinical Research, Llc
City
Houston
State/Province
Texas
ZIP/Postal Code
77035
Country
United States
Facility Name
North Hills Medical Research, Inc.
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Med-Olam Clinical Research
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Sam Clinical Research Center
City
San Antoinio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Covenant Clinical Research, Pa
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hillcrest Family Health Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Val R. Hansen, M.D.
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Southwestern Vermont Med Cntr
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Hampton Roads Center For Clinical Research, Inc.
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
Local Institution
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3V9
Country
Canada
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E3P4
Country
Canada
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Local Institution
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Local Institution
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Local Institution
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Local Institution
City
Sungnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-774
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Local Institution
City
Cuautla
State/Province
Morelos
ZIP/Postal Code
62744
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Local Institution
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Local Institution
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Local Institution
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Local Institution
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Local Institution
City
Katowice
ZIP/Postal Code
40-057
Country
Poland
Facility Name
Local Institution
City
Katowice
ZIP/Postal Code
40954
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
30-015
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Local Institution
City
Opole
ZIP/Postal Code
45-367
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
61-655
Country
Poland
Facility Name
Local Institution
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Local Institution
City
Cidra
ZIP/Postal Code
00739
Country
Puerto Rico
Facility Name
Local Institution
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Local Institution
City
Villa Fontana
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Local Institution
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100018
Country
Romania
Facility Name
Local Institution
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100163
Country
Romania
Facility Name
Local Institution
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300736
Country
Romania
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
050538
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
020359
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
11794
Country
Romania
Facility Name
Local Institution
City
Cluj Napoca Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Local Institution
City
Craiova
ZIP/Postal Code
200349
Country
Romania
Facility Name
Local Institution
City
Galati
ZIP/Postal Code
800098
Country
Romania
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Local Institution
City
Gauteng
State/Province
Johannesburg
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
Goodwood
State/Province
Western Cape
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Local Institution
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Local Institution
City
Rondebosch
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Local Institution
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Local Institution
City
Johannesburg
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Local Institution
City
Johannesburg
ZIP/Postal Code
2129
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
25352655
Citation
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.
Results Reference
result
PubMed Identifier
31364269
Citation
Bailey 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.
Results Reference
derived
PubMed Identifier
30304106
Citation
Rosenstock 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.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3665&filename=CV_181169_Protocol_Redacted.pdf
Description
CV_181169_Protocol_Redacted
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3665&filename=CV181169_Synopsis.pdf
Description
CV181169_Synopsis
Learn more about this trial
Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
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