A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01137474
First received: June 3, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to learn whether 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 or an angiotensin receptor blocker. The safety of this treatment will also be studied.


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Placebo-matching dapagliflozin
Drug: Oral antidiabetic agent
Drug: Angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB)
Drug: With or without insulin
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 Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

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 (BP) at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained 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 to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.

  • Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward) [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.

  • Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.

  • Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.

  • Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
    Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.


Other Outcome Measures:
  • Number of Participants With Adverse Events (AEs), Hypoglycemic Events, Related AEs, Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Discontinuations Due to AEs, and Discontinuations Due to Hypoglycemic Events [ Time Frame: Day 1 of treatment to last dose plus 4 days for AEs and hypoglycemic events and plus 30 days for SAEs ] [ Designated as safety issue: Yes ]
    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 unknown relationship to study drug. Includes nonserious AEs with onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment plus 4 days and SAEs with onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment plus 30 days. Includes data after rescue. 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 Clinical Laboratory Results Meeting Criteria for Marked Abnormality [ Time Frame: Day 1 of treatment to last dose, plus 4 days ] [ Designated as safety issue: Yes ]
    Laboratory abnormalities were evaluated based on laboratory values meeting predefined marked abnormality (MA) criteria. Includes data after the start date of double-blind treatment up to and including the last day of double-blind treatment plus 4 days. BUN=blood urea nitrogen; preRX=pretreatment; unspecif=unspecified; ULN=upper limit of normal. High total calcium= ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRX value; high inorganic phosphorus= ≥5.6 mg/dL if age 17-65 years or ≥5.1 mg/dL if age ≥66 years.

  • Changes From Baseline in Electrocardiogram (ECG) Findings at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    The normality or abnormality of the ECG tracing, determined by the investigator, was summarized by normal or abnormal ECG tracing at Week 12 overall and at baseline. When the data at Week 12 were not available, the last observation before discontinuation of that patient was used for summary.

  • Changes From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure (BP) at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    Supine BP was measured prior to standing BP. The patient was to rest in the supine position for at least 5 minutes prior to measurement of BP. Supine BP was determined from 3 replicate measurements obtained at least 1 minute apart. The average BP was determined from these 3 replicate measurements. The patient then stood for 2 to 3 minutes. After this time, BP was measured with the arm supported at the antecubital fossa at heart level.

  • Changes From Baseline in Supine and Standing Heart Rate (HR) at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    Supine HR was measured prior to the standing HR. The patient was to rest in the supine position for at least 5 minutes prior to measurement of HR. Supine HR will be determined from 3 replicate measurements obtained at least 1 minute apart. The average HR was determined from these 3 replicate measurements and reported in the case report form. The patient then stood for 2 to 3 minutes. All measurements were to occur at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine.

  • Changes From Baseline in 24-Hour Ambulatory Heart Rate at Week 12 [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: Yes ]
    Changes from baseline in 24-hour mean ambulatory heart rate were summarized at each visit using descriptive statistics.

  • Number of Participants With Elevated Results of Liver Laboratory Tests [ Time Frame: Day 1 of double-blind treatment to last double-blind dose, plus 30 days ] [ Designated as safety issue: Yes ]
    ALT=alanine aminotransferase; ALP=alkaline phosphatase


Enrollment: 2996
Study Start Date: July 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
Oral tablets administered as 10 mg once daily for up to 12 weeks
Drug: Dapagliflozin
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Other Name: BMS-512148
Drug: Oral antidiabetic agent Drug: Angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB)
Patients were previously taking an ACE inhibitor or ARB
Drug: With or without insulin
Patients may or may not have been taking insulin
Placebo Comparator: Placebo-matching dapagliflozin
Oral tablets administered once daily in the morning
Drug: Placebo-matching dapagliflozin
Oral tablets administered as 0 mg once daily for up to 12 weeks
Drug: Oral antidiabetic agent Drug: Angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB)
Patients were previously taking an ACE inhibitor or ARB
Drug: With or without insulin
Patients may or may not have been taking insulin
Experimental: Dapagliflozin, 2. 5 mg
Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Drug: Dapagliflozin
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Other Name: BMS-512148
Drug: Oral antidiabetic agent Drug: Angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB)
Patients were previously taking an ACE inhibitor or ARB
Drug: With or without insulin
Patients may or may not have been taking insulin
Experimental: Dapagliflozin, 5 mg
Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
Drug: Dapagliflozin
Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
Other Name: BMS-512148
Drug: Oral antidiabetic agent Drug: Angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB)
Patients were previously taking an ACE inhibitor or ARB
Drug: With or without insulin
Patients may or may not have been taking insulin

  Eligibility

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

Key inclusion criteria

  • Participants willing and able to give signed and written informed consent
  • Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (systolic blood pressure of 140 to 165 mm Hg and diastolic blood pressure 85 to 105 mm Hg)
  • Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
  • C-peptide level ≥0.8 ng/mL
  • Body mass index 45.0 kg/m^2

Key exclusion criteria

  • Aspartate aminotransferase or alanine aminotransferase level >3*upper limit of normal (ULN)
  • Serum total bilirubin level >1.5*ULN
  • Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for women and ≥1.40 mg/dL for men
  • Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women
  • Estimated creatinine clearance of <60 mL/min
  • Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
  • Creatine kinase >3*ULN
  • Positive for hepatitis B surface antigen
  • Positive for antihepatitis C virus antibody
  • Abnormal free T4 value
  • History of diabetes insipidus
  • Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • History of malignant and accelerated hypertension
  • Known or suspected secondary hypertension
  • Any of the following within 6 months of enrollment visit:

    • Myocardial infarction
    • Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
    • Unstable angina
    • Unstable congestive heart disease New York Heart Association Class III or IV
    • Transient ischemic attack or significant cerebrovascular disease
    • Unstable or previously undiagnosed arrhythmia
  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: NCT01137474

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
Iicr, Inc. (International Institute Of Clinical Research)
Ozark, Alabama, United States, 36360
United States, Arizona
43rd Medical Associates
Phoenix, Arizona, United States, 85051
Hope Research Institute
Phoenix, Arizona, United States, 85050
Central Phoenix Medical Clinic, Llc
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
Orange County Research Institute
Anaheim, California, United States, 92801
Cmp Research
Anaheim, California, United States, 92805
Med Center
Carmichael, California, United States, 95608
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
Marina Raikhel, M.D., F.A.A.F.P
Lomita, California, United States, 90717
National Research Inst
Los Angeles, California, United States, 90057
Randall G. Shue, D.O.
Los Angeles, California, United States, 90023
American Institute Of Research
Los Angeles, California, United States, 90017
Clinica Medica San Miguel
Los Angeles, California, United States, 90015
Quest Diagnostics West Hills
Los Angeles, California, United States, 90057
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
Integrated Research Group, Inc.
Riverside, California, United States, 92506
Quality Control Research, Inc
Sacramento, California, United States, 95842
Crest Clinical Trials, Inc.
Santa Ana, California, United States, 92701
Orrin M. Troum, Md And Medical Associates
Santa Monica, California, United States, 90404
Orange County Research Center
Tustin, California, United States, 92780
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
Infosphere Clinical Research, Inc.
West Hills, California, United States, 91307
United States, Colorado
Aurora Family Medicine, P.C.
Aurora, Colorado, United States, 80012
Horizons Clinical Research Center, Llc
Denver, Colorado, United States, 80220
United States, Connecticut
Chase Medical Research, Llc
Waterbury, Connecticut, United States, 06708
United States, Florida
Zasa Clinical Research
Boynton Beach, Florida, United States, 33472
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Meridien Research
Brooksville, Florida, United States, 34601
Family Care Associates Of Nw Fl
Chipley, Florida, United States, 32428
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
In Vivo Clinical Research
Doral, Florida, United States, 33166
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
The Community Research Of South Florida
Hialeah, Florida, United States, 33016
Community Research Foundation, Inc.
Miami, Florida, United States, 33155
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
International Research Associates, Llc
Miami, Florida, United States, 33125
Medical Research Marseilles
Miami, Florida, United States, 33155
Flcri Global Research, Llc
Miami, Florida, United States, 33125
Clinical Research Of Miami, Inc.
Miami, Florida, United States, 33126
Apf Research, Llc
Miami, Florida, United States, 33135
Baptist Diabetes Associates, Pa
Miami, Florida, United States, 33156
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
Compass Research, Llc
Orlando, Florida, United States, 32806
South Miami Clinical Research, Llc
South Miami, Florida, United States, 33143
Meridien Research
St Petersburg, Florida, United States, 33709
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 Clinical Research Center, Llc
Perry, Georgia, United States, 31069
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
United States, Illinois
James R. Herron, Md, Ltd
Chicago, Illinois, United States, 60610
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
Crescent City Clinical Research Center
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
Neurocare, Inc.
Brookline, Massachusetts, United States, 02446
Genesis Clinical Research, Llc
Fall River, Massachusetts, United States, 02720
Hci-Metromedic Walk-In Medical Office
New Bedford, Massachusetts, United States, 02740
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
Jackson Clinic
Rolling Fork, Mississippi, United States, 39159
United States, Missouri
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109
St. Louis Center For Clinical Research
St. Louis, Missouri, United States, 63128
United States, Montana
Kcumb Dybedal Clinical Research Center
Kansas City, Montana, United States, 64106
United States, Nevada
Clin Research Advantage, Inc. James Meli, Do Family Pracice
Henderson, Nevada, United States, 89014
Independent Clinical Researchers@ Wolfson Medical Center
Las Vegas, Nevada, United States, 89103
Palm Medical Research Center
Las Vegas, Nevada, United States, 89148
Office Of Ted Thorp, Md
Las Vegas, Nevada, United States, 89102
Clinical Research Advantage, Inc.
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Joslin Diabetes Center Affiliate Of Snhmc
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Central Jersey Medical Research Center
Elizabeth, New Jersey, United States, 07202
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
Barat Research Group, Inc.
Charlotte, North Carolina, United States, 28262
Pharmquest
Greensboro, North Carolina, United States, 27408
Burke Primary Care
Morganton, North Carolina, United States, 28655
Pmg Research Of Wilmington Llc
Wilmington, North Carolina, United States, 28401
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
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States, 44130
Clinical Research Source, Inc
Perrysburg, Ohio, United States, 43551
United States, Oklahoma
Integris Family Care Central
Oklahoma City, Oklahoma, United States, 73112
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
Fanno Creek Clinic
Portland, Oregon, United States, 97219
United States, Pennsylvania
Southeastern Pa Medical Institute
Broomall, Pennsylvania, United States, 19008
Abington Memorial Hos/Feasterville Family Health Care Center
Feasterville Trevose, 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
Banksville Medical Pc
Pittsburgh, Pennsylvania, United States, 15216
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
Southeastern Research Associates, Inc.
Anderson, South Carolina, United States, 29621
Southeastern Research Associates, Inc.
Greenville, South Carolina, United States, 29605
Hillcrest Clinical Reseach, Llc
Simpsonville, South Carolina, United States, 29681
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
Chattanooga Research & Medicine, Pllc
Chattanooga, Tennessee, United States, 37404
Complete Family Care Of Knoxville, Pllc
Knoxville, Tennessee, United States, 37923
Premier Internal Medicine
Memphis, Tennessee, United States, 38119
United States, Texas
Arlington Family Research Center, Inc.
Arlington, Texas, United States, 76012
Internal Medicine Clinical Research
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
Excel Clinical Research, Llc
Houston, Texas, United States, 77081
Mercury Clinical Research
Houston, Texas, United States, 77036
Lone Star Clinical Research
Houston, Texas, United States, 77088
Southwest Clinical Trials
Houston, Texas, United States, 77074
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
Covenant Clinical Research, Pa
San Antonio, Texas, United States, 78229
Abbott Clinical Research Group, Inc.
San Antonio, Texas, United States, 78224
Sun Research Institute
San Antonio, Texas, United States, 78215
Breco Research, Ltd
Sugarland, Texas, United States, 77479
Pioneer Research Solutions, Inc.
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
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
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
United States, Washington
Sound Medical Research
Port Orchard, Washington, United States, 98366
Canada, British Columbia
Local Institution
Kelowona, British Columbia, Canada, V1Y 3G8
Local Institution
Victoria, British Columbia, Canada, V8V 3N7
Canada, Ontario
Local Institution
Brampton, Ontario, Canada, L6T 0G1
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
Medellin, Antioquia, Colombia, 0000
Local Institution
Bogota, Cundinamarca, Colombia, 0000
Local Institution
Armenia, Quindio, Colombia, 0000
Local Institution
Cali, Valle, 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
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, 2300
Local Institution
Copenhagen, Denmark, 2400
Local Institution
Frederiksberg, Denmark, DK-2000
Local Institution
Slagelse, Denmark, 4200
Finland
Local Institution
Kokkola, Finland, 67100
Local Institution
Oulu, Finland, 90100
Germany
Local Institution
Aschaffenburg, Bavaria, Germany, 63739
Local Institution
Vellmar, Hessen, Germany, 34246
Local Institution
Duisburg, Nordrhein-Westfalen, Germany, 47051
Local Institution
Bad Kreuznach, Germany, 55545
Local Institution
Berlin, Germany, 10787
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
Pirna, Germany, 01796
Local Institution
Saarbruecken, Germany, 66121
Hungary
Local Institution
Gyongyos, Heves, Hungary, 3200
Local Institution
Eger, Hungary, 3300
Local Institution
Hatvan, Hungary, 3000
Local Institution
Miskolc, Hungary, 3530
Local Institution
Nagykanizsa, Hungary, 8800
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
Local Institution
Szentes, Hungary, 6600
India
Local Institution
Hyderabad, Andhra Pradesh, India, 500 034
Local Institution
Vijayawada, Andhra Pradesh, India, 520008
Local Institution
New Delhi, Delhi, India, 110070
Local Institution
Bangalore, Karnataka, India, 560 043
Local Institution
Bangalore, Karnataka, India, 560043
Local Institution
Belgaum, Karnatka, India, 590010
Local Institution
Indore, Madhya Pradesh, India, 452010
Local Institution
Nagpur, Maharashtra, India, 440010
Local Institution
Nagpur, Maharashtra, India, 440033
Local Institution
Nagpur, Maharashtra, India, 440012
Local Institution
Delhi, New Delhi, India, 110007
Local Institution
Jaipur, Rajasthan, India, 302004
Local Institution
Jaipur, Rajasthan, India, 202023
Local Institution
Jaipur, Rajasthan, India, 302 001
Local Institution
Coimbatore, Tamil Nadu, India, 641018
Local Institution
Madurai, Tamilnadu, India, 625020
Local Institution
Bangalore, India, 560092
Local Institution
Hyderabad, India, 500063
Local Institution
Manipal, India, 576104
Local Institution
Nagpur, India, 440012
Mexico
Local Institution
Torreon, Coahuila, Mexico, 27000
Local Institution
Del. Benito Juarez, Distrito Federal, Mexico, 03100
Local Institution
Mexico City, Distrito Federal, Mexico, 07760
Local Institution
Mexico, Df, Distrito Federal, Mexico, 06700
Local Institution
Tlalpan, Distrito Federal, Mexico, 14000
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Guadalajara, Jalisco, Mexico, 44100
Local Institution
Guadalajara, Jalisco, Mexico, 44600
Local Institution
Cuautla, Morelos, Mexico, 62744
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
Durango, Mexico, 34000
Local Institution
Guadalajara, Mexico, 44680
Local Institution
Puebla, Mexico, 72000
Local Institution
Queretaro, Mexico, 76000
Local Institution
Veracruz, Mexico, 91910
Peru
Local Institution
Chiclayo, Lambayeque, Peru
Local Institution
Lince, Lima, Peru, LIMA14
Local Institution
Arequipa, Peru
Local Institution
Arequipa, Peru, 54
Local Institution
Cusco, Peru
Local Institution
Ica, Peru, ICA01
Local Institution
Lima, Peru, LIMA 10
Local Institution
Lima, Peru, LIMA 31
Local Institution
Lima, Peru, LIMA 11
Local Institution
Lima, Peru, LIMA 33
Local Institution
Lima, Peru, 17
Local Institution
Piura, Peru
Poland
Local Institution
Bialystok, Poland, 15-404
Local Institution
Bydgoszcz, Poland, 85-822
Local Institution
Chrzanow, Poland, 32-500
Local Institution
Gdansk, Poland, 80-847
Local Institution
Gdynia, Poland, 80-384
Local Institution
Golub-Dobrzyn, Poland, 87-400
Local Institution
Kamieniec Zabkowicki, Poland, 57-230
Local Institution
Katowice, Poland, 40-748
Local Institution
Krakow, Poland, 30-015
Local Institution
Krakow, Poland, 31-159
Local Institution
Krakow, Poland, 31-949
Local Institution
Lodz, Poland, 91-078
Local Institution
Lodz, Poland, 90-242
Local Institution
Lodz, Poland, 92-003
Local Institution
Ostroda, Poland, 14-100
Local Institution
Poznan, Poland, 61-251
Local Institution
Szczecin, Poland, 70-506
Local Institution
Warsaw, Poland, 02-097
Local Institution
Warsaw, Poland, 01-231
Local Institution
Warszawa, Poland, 02-507
Local Institution
Warszawa, Poland, 02-679
Local Institution
Warszawa, Poland, 03-580
Local Institution
Warszawa, Poland, 01-868
Local Institution
Wroc#Aw, Poland, 50-088
Local Institution
WrocB Aw, Poland, 50-349
Local Institution
Zamosc, Poland, 22-400
Puerto Rico
Local Institution
Cidra, Puerto Rico, 00739
Local Institution
Ponce, Puerto Rico, 00716
Local Institution
Ponce, Puerto Rico, 00717
Local Institution
San Juan, Puerto Rico, 00918
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, 540098
Local Institution
Targu Mures, Mures, Romania, 540142
Local Institution
Ploiesti, Prahova, Romania, 100342
Local Institution
Ploiesti, Prahova, Romania, 100163
Local Institution
Timisoara, Timis, Romania, 300456
Local Institution
Bucuresti, Romania, 011478
Local Institution
Bucuresti, Romania, 020475
Local Institution
Bucuresti, Romania, 020359
Local Institution
Bucuresti, Romania, 010496
Local Institution
Satu Mare, Romania, 440055
Local Institution
Sibiu, Romania, 550245
Local Institution
Sibiu, Romania, 550371
Russian Federation
Local Institution
Dzerzhinskiy, Russian Federation, 140091
Local Institution
Krasnoyarsk, Russian Federation, 660022
Local Institution
Moscow, Russian Federation, 115093
Local Institution
Moscow, Russian Federation, 119992
Local Institution
Moscow, Russian Federation, 125367
Local Institution
Novosibirsk, Russian Federation, 630076
Local Institution
Saint Petersburg, Russian Federation, 197022
Local Institution
Saratov, Russian Federation, 410028
Local Institution
Smolensk, Russian Federation, 214018
Local Institution
St. Petersburg, Russian Federation, 191119
Local Institution
St.Petersburg, Russian Federation, 195112
Local Institution
Yaroslav, Russian Federation, 150062
Local Institution
Yaroslavl, Russian Federation, 150062
Local Institution
Yaroslavl, Russian Federation, 150003
Spain
Local Institution
Santiago De Compostela, A Coruna, Spain, 15706
Local Institution
Barcelona, Spain, 08036
Local Institution
La Roca Del Valles, Spain, 08430
Local Institution
Peralada, Spain, 17491
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: NCT01137474     History of Changes
Other Study ID Numbers: MB102-073 ST, 2010-019797-32
Study First Received: June 3, 2010
Results First Received: February 7, 2014
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Mexico: Secretaria de Salud
Germany: Federal Institute for Drugs and Medical Devices
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

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
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014