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
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin
Placebo matching Dapagliflozin
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Angiotensin Receptor Inhibitors, Angiotensin-Converting Enzyme Inhibitors, Antihypertensive Agents, Cardiovascular Agents, Pharmacological Actions
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- 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
Sites / Locations
- University Of Alabama At Birmingham
- Medical Affiliated Research Center, Inc.
- Wilmax Clinical Research, Inc.
- 43rd Medical Associates
- Central Phoenix Medical Center
- Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
- Clinical Research Advantage/Desert Clinical Research
- Visions Clinical Research - Tucson
- Eclipse Clinical Research
- Aureus Research, Inc.
- Preferred Research Partners, Inc.
- Cmp Research
- Catalina Research Institute, Llc
- Southland Clinical Research Center, Inc.
- Marin Endocrine Care & Research, Inc.
- Del Rosario Medical Clinic, Inc.
- Time Clinical Research Inc.
- Clinica Medica San Miguel
- American Institute Of Research
- Randall G. Shue, D.O.
- Mcs Clinical Trials
- National Research Inst
- Diabetes Medical Center Of California
- Valley Clinical Trials
- Lucita M. Cruz,Md.,Inc.
- Sds Clinical Trials
- Bayview Research Group, Llc
- San Diego Managed Care Group
- Integrated Research Group, Inc.
- Quality Control Research, Inc
- Wetlin Research Associates, Inc.
- Crest Clinical Trials, Inc.
- Neurological Research Institute
- Orrin M. Troum, Md And Medical Associates
- Torrance Clinical Research
- Orange County Research Center
- University Clinical Investigators, Inc.
- Chase Medical Research, Llc
- Christiana Care Health Services, Inc
- Zasa Clinical Research
- Bradenton Research Center, Inc.
- Innovative Research Of West Florida, Inc
- Clinical Research Of South Florida
- Avail Clinical Research, Llc
- International Research Associates, Llc
- Palm Springs Research Institute
- The Community Research Of South Florida
- Central Florida Internists
- Newphase Clinical Trials, Inc.
- Ocean Blue Medical Research Center, Inc.
- Flcri Global Research, Llc
- Clinical Research Of Miami, Inc.
- Pharmax Research Clinic, Inc.
- Apf Research, Llc
- Community Research Foundation, Inc.
- Baptist Diabetes Associates, Pa
- Suncoast Clinical Research, Inc.
- Florida Institute For Clinical Research, Llc
- Michele A. Morrison Internal Medicine, Inc.
- Medsol Clinical Research Center
- Meridien Research
- Perimeter Institute For Clinical Research
- Bainbridge Medical Associates
- River Birch Research Alliance, Llc
- In-Quest Medical Research, Llc
- Middle Georgia Drug Study Center, Llc
- Cedar Crosse Research Center
- So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
- Springfield Diabetes And Endocrine Center
- American Health Network Of Indiana Llc
- Investigators Research Group, Llc
- American Health Network Of In Llc
- Laporte County Institute For Clinical Research, Inc.
- American Health Network Of In Llc
- Medical Development Centers, Llc
- Omega Clinical Research, Llc
- Acadia Clinical Research, Llc
- Alternative Primary Care
- Hci-Metromedic Walk-In Medical Office
- Neurocare, Inc.
- Atlantic Clinical Trials, Llc
- Providence Park Clinical Research
- The Center For Clinical Trials
- Phillips Medical Services, Pllc
- Jefferson City Medical Group
- Kcumb Dybedal Clinical Research Center
- Clin Research Advantage, Inc. James Meli, Do Family Pracice
- Office Of Ted Thorp, Md
- Independent Clinical Researchers@ Wolfson Medical Center
- Clinical Research Advantage, Inc.
- Palm Medical Research Center
- Comprehensive Clinical Research
- Premier Research
- Medex Healthcare Research, Inc.
- Digiovanna Institute For Medical Education & Research
- Southgate Medical Group
- Diabetes & Endocrinology Consultants
- Burke Primary Care
- Lillestol Research
- Community Health Care, Inc.
- Community Research
- Parsons Avenue Medical Clinical
- Clinical Research Source, Inc
- Sooner Clinical Research
- Integris Family Care Yukon
- Willamette Valley Clinical Studies
- Southeastern Pa Medical Institute
- Abington Memorial Hos/Feasterville Family Health Care Center
- The Clinical Trial Center, Llc
- Arcuri Clinical Research Llc
- Philadelphia Health Associates - Adult Medicine
- Research Across America
- Pish Medical Associates
- Greater Providence Clinical Research, Llc
- Medical Research South
- Southeastern Research Associates, Inc.
- North Myrtle Beach Family Practice
- Pawleys Pediatrics And Adult Medicine
- Hillcrest Clinical Reseach, Llc
- Palmetto Clinical Research
- Southwind Medical Specialists
- Tn Medical Research
- Arlington Family Research Center, Inc.
- 3rd Coast Research Associates
- Krk Medical Research
- Research Institute Of Dallas
- Internal Medicine Clinical Reaseach
- Renaissance Clinical Research And Hypertension Pllc
- Sergio F. Rovner, M.D.
- Pioneer Research Solutions, Inc.
- Village Family Practice
- Dependable Clinical Research, Llc
- Southwest Clinical Trials
- Bellaire Medical Care Group
- Excel Clinical Research, Llc
- Hill Country Medical Associates
- North Hills Medical Research, Inc.
- Med-Olam Clinical Research
- Lisa E. Medwedeff, Md, Pa
- Sun Research Institute
- Abbott Clinical Research Group, Inc.
- Covenant Clinical Research, Pa
- Innovative Clinical Trials
- Breco Research, Ltd
- Exodus Healthcare Network
- Wasatch Endocrinology And Diabetes Specialists
- Wasatch Clinical Research
- Alexandria Health Care Center
- Millennium Clinical Trials Llc
- Burke Internal Medicine And Research
- Manassas Clinical Research Center
- Hampton Roads Center For Clinical Research, Inc.
- Larry D. Stonesifer, Md
- Sound Medical Research
- Clinical Investigation Specialists, Inc.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dapagliflozin 10 mg
Placebo matching Dapagliflozin
Arm Description
Dapagliflozin 10 mg tablets
Placebo tablets matching dapagliflozin tablets
Outcomes
Primary Outcome Measures
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants
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
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)
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
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)
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT01195662
First Posted
September 3, 2010
Last Updated
November 10, 2016
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01195662
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Angiotensin Receptor Inhibitors, Angiotensin-Converting Enzyme Inhibitors, Antihypertensive Agents, Cardiovascular Agents, Pharmacological Actions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin 10 mg
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg tablets
Arm Title
Placebo matching Dapagliflozin
Arm Type
Placebo Comparator
Arm Description
Placebo tablets matching dapagliflozin tablets
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
BMS-512148, Farxiga™
Intervention Description
Tablets, Oral, 10 mg, once daily, Up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching Dapagliflozin
Intervention Description
Tablets, Oral, 0 mg, once daily, Up to 12 weeks
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants
Description
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.
Time Frame
Baseline to Week 12
Title
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Baseline, Week 12
Title
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants
Description
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.
Time Frame
Baseline to Week 12
Title
Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)
Description
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.
Time Frame
Baseline, Week 12
Title
Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants
Description
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.
Time Frame
Baseline, Week 12
Title
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
Description
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.
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
Title
Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue
Description
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.
Time Frame
Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days
Title
Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue
Description
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.
Time Frame
Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days
Title
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue
Description
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.
Time Frame
Baseline, Week 12
Title
Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue
Description
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.
Time Frame
Baseline (Day 1), Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
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
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
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Wilmax Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
43rd Medical Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
Central Phoenix Medical Center
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Clinical Research Advantage/Desert Clinical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Visions Clinical Research - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Eclipse Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Aureus Research, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Cmp Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Catalina Research Institute, Llc
City
Chino
State/Province
California
ZIP/Postal Code
91710
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
Marin Endocrine Care & Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Del Rosario Medical Clinic, Inc.
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Time Clinical Research Inc.
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Clinica Medica San Miguel
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
American Institute Of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Randall G. Shue, D.O.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90023
Country
United States
Facility Name
Mcs Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
National Research Inst
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Diabetes Medical Center Of California
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Valley Clinical Trials
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
Sds Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Bayview Research Group, Llc
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
San Diego Managed Care Group
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Integrated Research Group, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Quality Control Research, Inc
City
Sacramento
State/Province
California
ZIP/Postal Code
95842
Country
United States
Facility Name
Wetlin Research Associates, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Crest Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Orrin M. Troum, Md And Medical Associates
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Chase Medical Research, Llc
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Christiana Care Health Services, Inc
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Zasa Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Bradenton Research Center, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Innovative Research Of West Florida, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research Of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Avail Clinical Research, Llc
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
International Research Associates, Llc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Palm Springs Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
The Community Research Of South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Central Florida Internists
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
Ocean Blue Medical Research Center, Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Flcri Global Research, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Clinical Research Of Miami, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Pharmax Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Apf Research, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Community Research Foundation, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist Diabetes Associates, Pa
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Florida Institute For Clinical Research, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Michele A. Morrison Internal Medicine, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Medsol Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Perimeter Institute For Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Bainbridge Medical Associates
City
Bainbridge
State/Province
Georgia
ZIP/Postal Code
39819
Country
United States
Facility Name
River Birch Research Alliance, Llc
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
In-Quest Medical Research, Llc
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Middle Georgia Drug Study Center, Llc
City
Perry
State/Province
Georgia
ZIP/Postal Code
31069
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
So. Illinois Clin Res Ctr @ Div Of Kevin L Pritchett Md, Pc
City
O?Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Springfield Diabetes And Endocrine Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
American Health Network Of Indiana Llc
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Investigators Research Group, Llc
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
American Health Network Of In Llc
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
Laporte County Institute For Clinical Research, Inc.
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
American Health Network Of In Llc
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Medical Development Centers, Llc
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Omega Clinical Research, Llc
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Acadia Clinical Research, Llc
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Alternative Primary Care
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Hci-Metromedic Walk-In Medical Office
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Neurocare, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Atlantic Clinical Trials, Llc
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Providence Park Clinical Research
City
Novi
State/Province
Michigan
ZIP/Postal Code
48374
Country
United States
Facility Name
The Center For Clinical Trials
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Phillips Medical Services, Pllc
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39209
Country
United States
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Kcumb Dybedal Clinical Research Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
Facility Name
Clin Research Advantage, Inc. James Meli, Do Family Pracice
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Office Of Ted Thorp, Md
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Independent Clinical Researchers@ Wolfson Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Medical Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Digiovanna Institute For Medical Education & Research
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Southgate Medical Group
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Diabetes & Endocrinology Consultants
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Community Health Care, Inc.
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Parsons Avenue Medical Clinical
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Clinical Research Source, Inc
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Integris Family Care Yukon
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Southeastern Pa Medical Institute
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Abington Memorial Hos/Feasterville Family Health Care Center
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
The Clinical Trial Center, Llc
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Arcuri Clinical Research Llc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19142
Country
United States
Facility Name
Philadelphia Health Associates - Adult Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Research Across America
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Pish Medical Associates
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Greater Providence Clinical Research, Llc
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Medical Research South
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Southeastern Research Associates, Inc.
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
North Myrtle Beach Family Practice
City
North Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29582
Country
United States
Facility Name
Pawleys Pediatrics And Adult Medicine
City
Pawleys Island
State/Province
South Carolina
ZIP/Postal Code
29585
Country
United States
Facility Name
Hillcrest Clinical Reseach, Llc
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Southwind Medical Specialists
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38125
Country
United States
Facility Name
Tn Medical Research
City
Spring Hill
State/Province
Tennessee
ZIP/Postal Code
37174
Country
United States
Facility Name
Arlington Family Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
3rd Coast Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Krk Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Institute Of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Internal Medicine Clinical Reaseach
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Renaissance Clinical Research And Hypertension Pllc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Sergio F. Rovner, M.D.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Village Family Practice
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Dependable Clinical Research, Llc
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Bellaire Medical Care Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Excel Clinical Research, Llc
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Hill Country Medical Associates
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
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
Lisa E. Medwedeff, Md, Pa
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Abbott Clinical Research Group, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Covenant Clinical Research, Pa
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Breco Research, Ltd
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Exodus Healthcare Network
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Wasatch Endocrinology And Diabetes Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Alexandria Health Care Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22314
Country
United States
Facility Name
Millennium Clinical Trials Llc
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Burke Internal Medicine And Research
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
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
Larry D. Stonesifer, Md
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Sound Medical Research
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Kelowona
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N7
Country
Canada
Facility Name
Local Institution
City
Monction
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
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L6T 3J1
Country
Canada
Facility Name
Local Institution
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2R 1V6
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Local Institution
City
Armenia
State/Province
Quindio
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Local Institution
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Local Institution
City
Barranquilla
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Local Institution
City
Barranquilla
Country
Colombia
Facility Name
Local Institution
City
Bogota
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Local Institution
City
Beroun
ZIP/Postal Code
266 01
Country
Czech Republic
Facility Name
Local Institution
City
Cheb
ZIP/Postal Code
350 02
Country
Czech Republic
Facility Name
Local Institution
City
Havirov
ZIP/Postal Code
736 01
Country
Czech Republic
Facility Name
Local Institution
City
Krnov
ZIP/Postal Code
794 01
Country
Czech Republic
Facility Name
Local Institution
City
Liberec
ZIP/Postal Code
460 01
Country
Czech Republic
Facility Name
Local Institution
City
Ostrava
ZIP/Postal Code
702 00
Country
Czech Republic
Facility Name
Local Institution
City
Prague 1
ZIP/Postal Code
116 94
Country
Czech Republic
Facility Name
Local Institution
City
Praha 4
ZIP/Postal Code
149 00
Country
Czech Republic
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
DK 2400
Country
Denmark
Facility Name
Local Institution
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Local Institution
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Local Institution
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
09200
Country
Finland
Facility Name
Local Institution
City
Kerava
ZIP/Postal Code
04200
Country
Finland
Facility Name
Local Institution
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Local Institution
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Local Institution
City
Aschaffenburg
State/Province
Bavaria
ZIP/Postal Code
63739
Country
Germany
Facility Name
Local Institution
City
Augsburg
State/Province
Bavaria
ZIP/Postal Code
86150
Country
Germany
Facility Name
Local Institution
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47051
Country
Germany
Facility Name
Local Institution
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Local Institution
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Karlsruhe
ZIP/Postal Code
76199
Country
Germany
Facility Name
Local Institution
City
Kothen
ZIP/Postal Code
06366
Country
Germany
Facility Name
Local Institution
City
Kronshagen
ZIP/Postal Code
24119
Country
Germany
Facility Name
Local Institution
City
Langenfeld
ZIP/Postal Code
40764
Country
Germany
Facility Name
Local Institution
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Local Institution
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Local Institution
City
Saarbruecken
ZIP/Postal Code
66121
Country
Germany
Facility Name
Local Institution
City
Wuestensachsen
ZIP/Postal Code
36115
Country
Germany
Facility Name
Local Institution
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
H-1171
Country
Hungary
Facility Name
Local Institution
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Local Institution
City
Kisvarda
ZIP/Postal Code
4600
Country
Hungary
Facility Name
Local Institution
City
Miskolc
ZIP/Postal Code
3530
Country
Hungary
Facility Name
Local Institution
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Local Institution
City
Satoraljaujhely
ZIP/Postal Code
3980
Country
Hungary
Facility Name
Local Institution
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Local Institution
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Local Institution
City
Szekszard
ZIP/Postal Code
H-7100
Country
Hungary
Facility Name
Local Institution
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
5000 18
Country
India
Facility Name
Local Institution
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 043
Country
India
Facility Name
Local Institution
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Local Institution
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
Local Institution
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Local Institution
City
Belgaum
State/Province
Karnatka
ZIP/Postal Code
590010
Country
India
Facility Name
Local Institution
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Local Institution
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Local Institution
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Local Institution
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440033
Country
India
Facility Name
Local Institution
City
Delhi
State/Province
New Delhi
ZIP/Postal Code
110007
Country
India
Facility Name
Local Institution
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
202023
Country
India
Facility Name
Local Institution
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600013
Country
India
Facility Name
Local Institution
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 018
Country
India
Facility Name
Local Institution
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625020
Country
India
Facility Name
Local Institution
City
Chennai Tamilnadu
ZIP/Postal Code
6000081
Country
India
Facility Name
Local Institution
City
Hyderabad
ZIP/Postal Code
500063
Country
India
Facility Name
Local Institution
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
Local Institution
City
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
Local Institution
City
Dublin 15
State/Province
Dublin
Country
Ireland
Facility Name
Local Institution
City
Galway
Country
Ireland
Facility Name
Local Institution
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
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
64000
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Local Institution
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Local Institution
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Local Institution
City
Del. Benito Juarez
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Local Institution
City
Delegacion Tlalpan
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Local Institution
City
Distrito Federal
ZIP/Postal Code
07020
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Local Institution
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Local Institution
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-847
Country
Poland
Facility Name
Local Institution
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Local Institution
City
Kamieniec Zabkowicki
ZIP/Postal Code
57-230
Country
Poland
Facility Name
Local Institution
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Local Institution
City
Kielce
ZIP/Postal Code
25-364
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
30-015
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
92-525
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Local Institution
City
Ostroda
ZIP/Postal Code
14-100
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
61-251
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-337
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Local Institution
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Local Institution
City
Fajard
ZIP/Postal Code
00738
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00920
Country
Puerto Rico
Facility Name
Local Institution
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410169
Country
Romania
Facility Name
Local Institution
City
Oradea
State/Province
Jud. Bihor
ZIP/Postal Code
410469
Country
Romania
Facility Name
Local Institution
City
Timisoara
State/Province
Jud. Timis
ZIP/Postal Code
300125
Country
Romania
Facility Name
Local Institution
City
Targu Mures
State/Province
Mures
ZIP/Postal Code
540098
Country
Romania
Facility Name
Local Institution
City
Targu Mures
State/Province
Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Local Institution
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100163
Country
Romania
Facility Name
Local Institution
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100342
Country
Romania
Facility Name
Local Institution
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300456
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
010507
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
020725
Country
Romania
Facility Name
Local Institution
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Local Institution
City
Satu Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Local Institution
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Local Institution
City
Sibiu
ZIP/Postal Code
550371
Country
Romania
Facility Name
Local Institution
City
Irvine
State/Province
Ayrshire
ZIP/Postal Code
KA11 1JU
Country
United Kingdom
Facility Name
Local Institution
City
Ely
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Local Institution
City
Bath
State/Province
Wiltshire
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26620248
Citation
Weber MA, Mansfield TA, Cain VA, Iqbal N, Parikh S, Ptaszynska A. Blood pressure and glycaemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Diabetes Endocrinol. 2016 Mar;4(3):211-220. doi: 10.1016/S2213-8587(15)00417-9. Epub 2015 Nov 27. Erratum In: Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3. Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
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
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