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A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01195662
First received: September 3, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Placebo matching Dapagliflozin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.

  • Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.

  • Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.

  • Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.

  • Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.

  • Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue [ Time Frame: Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event ] [ Designated as safety issue: Yes ]
    Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.

  • Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue [ Time Frame: Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days ] [ Designated as safety issue: Yes ]
    Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.

  • Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue [ Time Frame: Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days ] [ Designated as safety issue: Yes ]
    Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.

  • Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: Yes ]
    12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.

  • Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue [ Time Frame: Baseline (Day 1), Week 12 ] [ Designated as safety issue: Yes ]
    Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.


Enrollment: 2245
Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin (10 mg) Drug: Dapagliflozin
Tablets, Oral, 10 mg, once daily, Up to 12 weeks
Other Names:
  • BMS-512148
  • Farxiga™
Placebo Comparator: Placebo matching Dapagliflozin Drug: Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, Up to 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
  • Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit
  • Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks [12 wks for Thiazolidinedione (TZD)] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks
  • C-peptide ≥ 0.8 ng/mL
  • Body Mass Index ≤ 45.0 kg/m2
  • Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

  • Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0*upper limit of normal (ULN)
  • Serum total bilirubin ≥ 1.5*ULN
  • Creatinine kinase > 3*ULN
  • Symptoms of severely uncontrolled diabetes
  • History of malignant or accelerated hypertension
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195662

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
Wilmax Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
43rd Medical Associates
Phoenix, Arizona, United States, 85051
Central Phoenix Medical Center
Tempe, Arizona, United States, 85282
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, United States, 85282
Clinical Research Advantage/Desert Clinical Research
Tempe, Arizona, United States, 85282
Visions Clinical Research - Tucson
Tucson, Arizona, United States, 85712
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
United States, Arkansas
Aureus Research, Inc.
Little Rock, Arkansas, United States, 72211
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Cmp Research
Anaheim, California, United States, 92805
Catalina Research Institute, Llc
Chino, California, United States, 91710
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States, 94904
Time Clinical Research Inc.
Huntington Park, California, United States, 90255
Del Rosario Medical Clinic, Inc.
Huntington Park, California, United States, 90255
American Institute Of Research
Los Angeles, California, United States, 90017
Clinica Medica San Miguel
Los Angeles, California, United States, 90015
Mcs Clinical Trials
Los Angeles, California, United States, 90057
National Research Inst
Los Angeles, California, United States, 90057
Randall G. Shue, D.O.
Los Angeles, California, United States, 90023
Valley Clinical Trials
Northridge, California, United States, 91325
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Lucita M. Cruz,Md.,Inc.
Norwalk, California, United States, 90650
Sds Clinical Trials
Orange, California, United States, 92868
Bayview Research Group, Llc
Paramount, California, United States, 90723
San Diego Managed Care Group
Poway, California, United States, 92064
Integrated Research Group, Inc.
Riverside, California, United States, 92506
Quality Control Research, Inc
Sacramento, California, United States, 95842
Wetlin Research Associates, Inc.
San Diego, California, United States, 92120
Crest Clinical Trials, Inc.
Santa Ana, California, United States, 92701
Neurological Research Institute
Santa Monica, California, United States, 90404
Orrin M. Troum, Md And Medical Associates
Santa Monica, California, United States, 90404
Torrance Clinical Research
Torrance, California, United States, 90505
Orange County Research Center
Tustin, California, United States, 92780
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
United States, Connecticut
Chase Medical Research, Llc
Waterbury, Connecticut, United States, 06708
United States, Delaware
Christiana Care Health Services, Inc
Newark, Delaware, United States, 19713
United States, Florida
Zasa Clinical Research
Boynton Beach, Florida, United States, 33472
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Innovative Research Of West Florida, Inc
Clearwater, Florida, United States, 33756
Clinical Research Of South Florida
Coral Gables, Florida, United States, 33134
Avail Clinical Research, Llc
Deland, Florida, United States, 32720
International Research Associates, Llc
Hialeah, Florida, United States, 33012
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
The Community Research Of South Florida
Hialeah, Florida, United States, 33016
Central Florida Internists
Kissimmee, Florida, United States, 34741
Pharmax Research Clinic, Inc.
Miami, Florida, United States, 33126
Apf Research, Llc
Miami, Florida, United States, 33135
Baptist Diabetes Associates, Pa
Miami, Florida, United States, 33156
Clinical Research Of Miami, Inc.
Miami, Florida, United States, 33126
Community Research Foundation, Inc.
Miami, Florida, United States, 33155
Flcri Global Research, Llc
Miami, Florida, United States, 33125
Newphase Clinical Trials, Inc.
Miami Beach, Florida, United States, 33140
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States, 33166
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Florida Institute For Clinical Research, Llc
Orlando, Florida, United States, 32822
Michele A. Morrison Internal Medicine, Inc.
Pembroke Pines, Florida, United States, 33026
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952
Meridien Research
Tampa, Florida, United States, 33606
United States, Georgia
Perimeter Institute For Clinical Research
Atlanta, Georgia, United States, 30338
Bainbridge Medical Associates
Bainbridge, Georgia, United States, 39819
River Birch Research Alliance, Llc
Blue Ridge, Georgia, United States, 30513
In-Quest Medical Research, Llc
Duluth, Georgia, United States, 30096
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States, 31069
United States, Illinois
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
O?Fallon, Illinois, United States, 62269
Springfield Diabetes And Endocrine Center
Springfield, Illinois, United States, 62704
United States, Indiana
American Health Network Of Indiana Llc
Avon, Indiana, United States, 46123
Investigators Research Group, Llc
Brownsburg, Indiana, United States, 46112
American Health Network Of In Llc
Franklin, Indiana, United States, 46131
Laporte County Institute For Clinical Research, Inc.
Michigan City, Indiana, United States, 46360
American Health Network Of In Llc
Muncie, Indiana, United States, 47304
United States, Louisiana
Medical Development Centers, Llc
Baton Rouge, Louisiana, United States, 70808
Omega Clinical Research, Llc
Metairie, Louisiana, United States, 70006
United States, Maine
Acadia Clinical Research, Llc
Bangor, Maine, United States, 04401
United States, Maryland
Alternative Primary Care
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Hci-Metromedic Walk-In Medical Office
New Bedford, Massachusetts, United States, 02740
Neurocare, Inc.
Newton, Massachusetts, United States, 02459
Atlantic Clinical Trials, Llc
Watertown, Massachusetts, United States, 02472
United States, Michigan
Providence Park Clinical Research
Novi, Michigan, United States, 48374
United States, Mississippi
The Center For Clinical Trials
Biloxi, Mississippi, United States, 39531
Phillips Medical Services, Pllc
Jackson, Mississippi, United States, 39209
United States, Missouri
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109
Kcumb Dybedal Clinical Research Center
Kansas City, Missouri, United States, 64106
United States, Nevada
Clin Research Advantage, Inc. James Meli, Do Family Pracice
Henderson, Nevada, United States, 89014
Palm Medical Research Center
Las Vegas, Nevada, United States, 89148
Independent Clinical Researchers@ Wolfson Medical Center
Las Vegas, Nevada, United States, 89103
Office Of Ted Thorp, Md
Las Vegas, Nevada, United States, 89102
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Premier Research
Trenton, New Jersey, United States, 08611
United States, New York
Medex Healthcare Research, Inc.
New York, New York, United States, 10022
Digiovanna Institute For Medical Education & Research
North Massapequa, New York, United States, 11758
Southgate Medical Group
West Seneca, New York, United States, 14224
United States, North Carolina
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States, 28557
Burke Primary Care
Morganton, North Carolina, United States, 28655
United States, North Dakota
Lillestol Research
Fargo, North Dakota, United States, 58103
United States, Ohio
Community Health Care, Inc.
Canal Fulton, Ohio, United States, 44614
Community Research
Cincinnati, Ohio, United States, 45227
Parsons Avenue Medical Clinical
Columbus, Ohio, United States, 43207
Clinical Research Source, Inc
Perrysburg, Ohio, United States, 43551
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
Integris Family Care Yukon
Yukon, Oklahoma, United States, 73099
United States, Oregon
Willamette Valley Clinical Studies
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Southeastern Pa Medical Institute
Broomall, Pennsylvania, United States, 19008
Abington Memorial Hos/Feasterville Family Health Care Center
Feasterville, Pennsylvania, United States, 19053
The Clinical Trial Center, Llc
Jenkintown, Pennsylvania, United States, 19046
Arcuri Clinical Research Llc
Philadelphia, Pennsylvania, United States, 19142
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, United States, 19146
Research Across America
Reading, Pennsylvania, United States, 19606
Pish Medical Associates
Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
Greater Providence Clinical Research, Llc
Warwick, Rhode Island, United States, 02888
United States, South Carolina
Medical Research South
Charleston, South Carolina, United States, 29407
Southeastern Research Associates, Inc.
Greenville, South Carolina, United States, 29605
North Myrtle Beach Family Practice
North Myrtle Beach, South Carolina, United States, 29582
Pawleys Pediatrics And Adult Medicine
Pawleys Island, South Carolina, United States, 29585
Hillcrest Clinical Reseach, Llc
Simpsonville, South Carolina, United States, 29681
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
Southwind Medical Specialists
Memphis, Tennessee, United States, 38125
Tn Medical Research
Spring Hill, Tennessee, United States, 37174
United States, Texas
Arlington Family Research Center, Inc.
Arlington, Texas, United States, 76012
3rd Coast Research Associates
Corpus Christi, Texas, United States, 78414
Internal Medicine Clinical Reaseach
Dallas, Texas, United States, 75235
Krk Medical Research
Dallas, Texas, United States, 75230
Renaissance Clinical Research And Hypertension Pllc
Dallas, Texas, United States, 75235
Research Institute Of Dallas
Dallas, Texas, United States, 75231
Sergio F. Rovner, M.D.
El Paso, Texas, United States, 79925
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77008
Dependable Clinical Research, Llc
Houston, Texas, United States, 77074
Excel Clinical Research, Llc
Houston, Texas, United States, 77081
Bellaire Medical Care Group
Houston, Texas, United States, 77081
Southwest Clinical Trials
Houston, Texas, United States, 77074
Village Family Practice
Houston, Texas, United States, 77024
Hill Country Medical Associates
New Braunfels, Texas, United States, 78130
North Hills Medical Research, Inc.
North Richland Hills, Texas, United States, 76180
Med-Olam Clinical Research
Pasadena, Texas, United States, 77504
Lisa E. Medwedeff, Md, Pa
Plano, Texas, United States, 75024
Abbott Clinical Research Group, Inc.
San Antonio, Texas, United States, 78224
Covenant Clinical Research, Pa
San Antonio, Texas, United States, 78229
Sun Research Institute
San Antonio, Texas, United States, 78215
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Breco Research, Ltd
Sugarland, Texas, United States, 77479
United States, Utah
Exodus Healthcare Network
Magna, Utah, United States, 84044
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Wasatch Endocrinology And Diabetes Specialists
Salt Lake City, Utah, United States, 84102
United States, Virginia
Alexandria Health Care Center
Alexandria, Virginia, United States, 22314
Millennium Clinical Trials Llc
Arlington, Virginia, United States, 22203
Burke Internal Medicine And Research
Burke, Virginia, United States, 22015
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, United States, 23435
United States, Washington
Larry D. Stonesifer, Md
Federal Way, Washington, United States, 98003
Sound Medical Research
Port Orchard, Washington, United States, 98366
United States, Wisconsin
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States, 53142
Australia, New South Wales
Local Institution
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Local Institution
Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Canada, British Columbia
Local Institution
Kelowona, British Columbia, Canada, V1Y 3G8
Local Institution
Victoria, British Columbia, Canada, V8V 3N7
Canada, New Brunswick
Local Institution
Monction, New Brunswick, Canada, E1G 1A7
Canada, Ontario
Local Institution
Brampton, Ontario, Canada, L6T 3J1
Canada, Quebec
Local Institution
Granby, Quebec, Canada, J2G 8Z9
Local Institution
Montreal, Quebec, Canada, H2R 1V6
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7K 3H3
Colombia
Local Institution
Armenia, Quindio, Colombia, 0000
Local Institution
Bucaramanga, Santander, Colombia, 0000
Local Institution
Barranquilla, Colombia, -----
Local Institution
Barranquilla, Colombia, 0000
Local Institution
Bogota, Colombia, 0000
Czech Republic
Local Institution
Beroun, Czech Republic, 266 01
Local Institution
Cheb, Czech Republic, 350 02
Local Institution
Havirov, Czech Republic, 736 01
Local Institution
Krnov, Czech Republic, 794 01
Local Institution
Liberec, Czech Republic, 460 01
Local Institution
Ostrava, Czech Republic, 702 00
Local Institution
Prague 1, Czech Republic, 116 94
Local Institution
Praha 4, Czech Republic, 149 00
Denmark
Local Institution
Copenhagen, Denmark, DK 2400
Local Institution
Frederiksberg, Denmark, 2000
Local Institution
Gentofte, Denmark, 2820
Local Institution
Slagelse, Denmark, 4200
Finland
Local Institution
Helsinki, Finland, 09200
Local Institution
Kerava, Finland, 04200
Local Institution
Kokkola, Finland, 67100
Local Institution
Oulu, Finland, 90100
Germany
Local Institution
Aschaffenburg, Bavaria, Germany, 63739
Local Institution
Augsburg, Bavaria, Germany, 86150
Local Institution
Duisburg, Nordrhein-Westfalen, Germany, 47051
Local Institution
Bad Kreuznach, Germany, 55545
Local Institution
Berlin, Germany, 10787
Local Institution
Dortmund, Germany, 44137
Local Institution
Dresden, Germany, 01307
Local Institution
Karlsruhe, Germany, 76199
Local Institution
Kothen, Germany, 06366
Local Institution
Kronshagen, Germany, 24119
Local Institution
Langenfeld, Germany, 40764
Local Institution
Lueneburg, Germany, 21339
Local Institution
Magdeburg, Germany, 39112
Local Institution
Mainz, Germany, 55116
Local Institution
Mannheim, Germany, 68161
Local Institution
Saarbruecken, Germany, 66121
Local Institution
Wuestensachsen, Germany, 36115
Hungary
Local Institution
Gyongyos, Heves, Hungary, 3200
Local Institution
Budapest, Hungary, 1134
Local Institution
Budapest, Hungary, H-1171
Local Institution
Eger, Hungary, 3300
Local Institution
Kisvarda, Hungary, 4600
Local Institution
Miskolc, Hungary, 3530
Local Institution
Nyiregyhaza, Hungary, 4400
Local Institution
Satoraljaujhely, Hungary, 3980
Local Institution
Sopron, Hungary, 9400
Local Institution
Szeged, Hungary, 6720
Local Institution
Szekszard, Hungary, H-7100
India
Local Institution
Hyderabad, Andhra Pradesh, India, 5000 18
Local Institution
Bangalore, Karnataka, India, 560 043
Local Institution
Bangalore, Karnataka, India, 560092
Local Institution
Bangalore, Karnataka, India, 560043
Local Institution
Mangalore, Karnataka, India, 575001
Local Institution
Belgaum, Karnatka, India, 590010
Local Institution
Indore, Madhya Pradesh, India, 452010
Local Institution
Nagpur, Maharashtra, India, 440010
Local Institution
Nagpur, Maharashtra, India, 440012
Local Institution
Nagpur, Maharashtra, India, 440033
Local Institution
Delhi, New Delhi, India, 110007
Local Institution
Jaipur, Rajasthan, India, 202023
Local Institution
Chennai, Tamil Nadu, India, 600013
Local Institution
Coimbatore, Tamil Nadu, India, 641 018
Local Institution
Madurai, Tamilnadu, India, 625020
Local Institution
Chennai Tamilnadu, India, 6000081
Local Institution
Hyderabad, India, 500063
Local Institution
Nagpur, India, 440012
Local Institution
Trivandrum, India, 695011
Ireland
Local Institution
Dublin 15, Dublin, Ireland
Local Institution
Galway, Ireland
Mexico
Local Institution
Torreon, Coahuila, Mexico, 27000
Local Institution
Mexico City, Distrito Federal, Mexico, 07760
Local Institution
Mexico City, Distrito Federal, Mexico, 03300
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Guadalajara, Jalisco, Mexico, 44130
Local Institution
Guadalajara, Jalisco, Mexico, 44100
Local Institution
Cuautla, Morelos, Mexico, 62744
Local Institution
Monterrey, Nuevo Leon, Mexico, 64000
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Culiacan, Sinaloa, Mexico, 80020
Local Institution
Merida, Yucatan, Mexico, 97070
Local Institution
Chihuahua, Mexico, 31217
Local Institution
Del. Benito Juarez, Mexico, 03100
Local Institution
Delegacion Tlalpan, Mexico, 14000
Local Institution
Distrito Federal, Mexico, 07020
Local Institution
San Luis Potosi, Mexico, 78200
Poland
Local Institution
Bialystok, Poland, 15-879
Local Institution
Bialystok, Poland, 15-404
Local Institution
Chrzanow, Poland, 32-500
Local Institution
Elblag, Poland, 82-300
Local Institution
Gdansk, Poland, 80-847
Local Institution
Gdynia, Poland, 81-384
Local Institution
Kamieniec Zabkowicki, Poland, 57-230
Local Institution
Katowice, Poland, 40-748
Local Institution
Kielce, Poland, 25-364
Local Institution
Krakow, Poland, 30-015
Local Institution
Krakow, Poland, 31-159
Local Institution
Lodz, Poland, 92-525
Local Institution
Lodz, Poland, 90-242
Local Institution
Lublin, Poland, 20-044
Local Institution
Ostroda, Poland, 14-100
Local Institution
Poznan, Poland, 61-251
Local Institution
Warsaw, Poland, 02-507
Local Institution
Warsaw, Poland, 02-097
Local Institution
Warszawa, Poland, 01-337
Local Institution
Warszawa, Poland, 01-192
Local Institution
Warszawa, Poland, 01-868
Local Institution
Wroclaw, Poland, 50-349
Local Institution
Wroclaw, Poland, 50-088
Local Institution
Zabrze, Poland, 41-800
Puerto Rico
Local Institution
Fajard, Puerto Rico, 00738
Local Institution
Ponce, Puerto Rico, 00717
Local Institution
San Juan, Puerto Rico, 00920
Romania
Local Institution
Oradea, Bihor, Romania, 410169
Local Institution
Oradea, Jud. Bihor, Romania, 410469
Local Institution
Timisoara, Jud. Timis, Romania, 300125
Local Institution
Targu Mures, Mures, Romania, 540142
Local Institution
Targu Mures, Mures, Romania, 540098
Local Institution
Ploiesti, Prahova, Romania, 100342
Local Institution
Ploiesti, Prahova, Romania, 100163
Local Institution
Timisoara, Timis, Romania, 300456
Local Institution
Bucuresti, Romania, 010719
Local Institution
Bucuresti, Romania, 010507
Local Institution
Bucuresti, Romania, 020725
Local Institution
Bucuresti, Romania, 020475
Local Institution
Cluj-Napoca, Romania, 400006
Local Institution
Satu Mare, Romania, 440055
Local Institution
Sibiu, Romania, 550371
Local Institution
Sibiu, Romania, 550245
United Kingdom
Local Institution
Irvine, Ayrshire, United Kingdom, KA11 1JU
Local Institution
Ely, Cambridgeshire, United Kingdom, CB7 5JD
Local Institution
Birmingham, West Midlands, United Kingdom, B9 5SS
Local Institution
Bath, Wiltshire, United Kingdom, BA2 3HT
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01195662     History of Changes
Other Study ID Numbers: MB102-077 ST, 2010-019798-13
Study First Received: September 3, 2010
Results First Received: February 7, 2014
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration
Mexico: Secretaria de Salud
Australia: Department of Health and Ageing Therapeutic Goods Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014