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Diabetes Mellitus, Type 2Phase 3NCT02182830

24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension

A Phase 3 study testing Empagliflozin low dose and Empagliflozin high dose in people with Diabetes Mellitus, Type 2 and Hypertension, run by Boehringer Ingelheim at 92 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Hypertension
What is being tested?
Empagliflozin low dose and Empagliflozin high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
92 sitesUnited States
Study dates
25 Jul 2014to 18 May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Type 2 Diabetes Mellitus (T2DM) prior to informed consent.
  • Male and female black/African American patients on diet and exercise regimen who are EITHER drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 (GLP-1) analog or insulin for 12 weeks, 16 weeks for pioglitazone prior to randomisation) OR pre-treated with stable dose of
  • Metformin only, or
  • Sulfonylurea only, or
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor only, or
  • metformin plus sulfonylurea, or
Show all 13Show fewer
  • metformin plus DPP-4 inhibitor. Treatment has to be unchanged for a minimum of 12 weeks prior to randomization. Dose for metformin: maximum tolerated dose The maximum daily dose of Sulfonylurea (SU) or DPP-4 inhibitor should not exceed that stated in the local label.
  • HbA1c of >= 7.0% (53 mmol/mol) and ≤ 11.0% (97 mmol/mol) at Visit 1 (screening).
  • Mean seated Systolic Blood Pressure (SBP) 140-180 mmHg at Visit 1 (screening).
  • Successful completion of baseline Ambulatory Blood Pressure Monitor (ABPM) testing with a mean SBP 135-175 mmHg prior to randomisation.
  • Treatment with stable doses of at least one but not more than 4 antihypertensive medication >= 4 weeks prior to randomisation.
  • Age >= 18 years at Visit 1 (screening)
  • Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

  • Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15.0 mmol/L) after an overnight fast during placebo run-in (includes Visit 2.1) and confirmed by a second measurement (not on the same day).
  • Exposure to any other antidiabetic medication within 12 weeks prior to randomisation other than metformin, sulfonylurea, Dipeptidyl peptidase-4 (DPP-4) inhibitor, metformin plus sulfonylurea or metformin plus DPP-4 inhibitor.
  • Current hypertension treatment with oral Minoxidil (topical minoxidil for hair growth is allowed).
  • Mean seated Systolic Blood Pressure (SBP) ≥181 mmHg during placebo run-in visit and confirmed by a second measurement (not on the same day) preferably within one day.
  • Upper arm circumference that exceeds the upper circumference level of the cuff size of either Ambulatory Blood Pressure Monitor (ABPM) and/or (BP) measurement device used in the study.
  • Night shift workers who routinely sleep during the daytime and/or whose work hours include midnight.
Show all 25Show fewer
  • Diagnosis of autoimmune diabetes/Type I diabetes mellitus, monogenic (neonatal or maturity onset diabetes of the young (MODY)) diabetes or Type I diabetes in adults/latent autoimmune diabetes of adults (LADA) per investigator or patient medical history at the time of Visit 1 (screening).
  • Known or suspected secondary hypertension (e.g. renal artery stenosis,phaeochromocytoma, Cushing's disease).
  • History or evidence of hypertensive retinopathy (Keith-Wagener grade III or IV) and/or hypertensive encephalopathy.
  • Clinically significant valvular heart disease or severe aortic stenosis in the opinion of the investigator.
  • Acute coronary syndrome (non- ST wave elevated myocardial infarction (STEMI), STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
  • Indication of liver disease, defined by serum levels of either Alanine Aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase(SGPT)), Aspartate Aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase.
  • Impaired renal function, defined as Estimated Glomerular Filtration Rate (eGFR)< 45 ml/min/1.73m2 (moderate renal impairment, chronic kidney disease epidemiology collaboration Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) as determined during screening and/or run-in phase.
  • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
  • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
  • Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cells (e.g. malaria, babesiosis, haemolytic anaemia, thalassemia, sickle cell anaemia (sickle cell trait is allowed)).
  • Medical history and signs and symptoms of diabetic autonomic neuropathy.
  • Treatment with anti-obesity drugs 3 months prior to randomisation (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
  • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes Mellitus (T2DM) in the opinion of the investigator.
  • Pre-menopausal women (last menstruation <=1 year prior to informed consent) who:
  • are nursing or pregnant or
  • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
  • Alcohol, drug or confectionary liquorice abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the investigator's opinion.
  • Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial; or participating in another trial (involving an investigational drug and/or follow-up) after discontinuing medication in that trial.
  • Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial in the opinion of the investigator.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87108

  • Millennium Clinical Trials LLC

    Arlington, Virginia, 22203

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Atlanta Center

    Atlanta, Georgia, 30331

  • Atlanta Clinical Research Centers

    Atlanta, Georgia, 30342

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • American Institute of Research Studies

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Birmingham, Alabama, 35211

  • Offic of Dr. Eric Cheng

    Brooklyn, New York, 11203-1203

  • Healthwise Medical Associates

    Brooklyn, New York, 11206

  • Modern Medical

    Brooklyn, New York, 11207

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Erie County Medical Center

    Buffalo, New York, 14215

  • Medical Research South

    Charleston, South Carolina, 29407

  • Metrolina Internal Medicine, PA

    Charlotte, North Carolina, 28204

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • John H. Stroger Jr. Hospital of Cook Country

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • eStudySite

    Chula Vista, California, 91911

  • TLM Medical Services, LLC

    Columbia, South Carolina, 29204

  • Amistad Clinical Research Center

    Columbia, South Carolina, 29223

  • Hometown Urgent Care

    Columbus, Ohio, 43214

  • Dayton Clinical Research

    Dayton, Ohio, 45406

  • Lynn Institute of Denver

    Denver, Colorado, 80246

  • Albert F. Johary MD, PC

    Dunwoody, Georgia, 30338

  • PhysiqueMed Clinical Trials

    Greensboro, North Carolina, 27405

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Greenville Pharmaceutical Rsch

    Greenville, South Carolina, 29615

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Peters Medical Research

    High Point, North Carolina, 27262

  • High Point Clinical Trials Center

    High Point, North Carolina, 27265

  • Pines Clinical Research Inc.

    Hollywood, Florida, 33024

  • Diagnostic Clinic of Houston

    Houston, Texas, 77004

  • Cullen Family Practice, PLLC

    Houston, Texas, 77051

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Kelsey-Seybold Clinic

    Houston, Texas, 77096

  • Longwood Research

    Huntsville, Alabama, 35801

  • Phillips Medical Services, PLLC

    Jackson, Mississippi, 39209

  • UF Health Jacksonville

    Jacksonville, Florida, 32207

  • Care Partners Clinical Research LLC

    Jacksonville, Florida, 32277

  • Centex Studies, Inc.

    Lake Charles, Louisiana, 70601

  • Accent Clinical Trials

    Las Vegas, Nevada, 89106

  • Scott Research, Inc.

    Laurelton, New York, 11413

  • Cardiology and Medicine Clinic

    Little Rock, Arkansas, 72204

  • Larry Watkins, M .D.

    Little Rock, Arkansas, 72205

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Long Beach Center for Clinical Research

    Long Beach, California, 90807

  • MD Clinical Trials

    Los Angeles, California, 90025

  • Office of Dr. Alexander Ford, M.D.

    Los Angeles, California, 90035

  • Sestron Clinical Research

    Marietta, Georgia, 30060

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Marietta, Georgia, 30067

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Memphis Veterans Affairs Medical Center

    Memphis, Tennessee, 38104

  • The Green Clinic PC

    Memphis, Tennessee, 38119

  • Southwind Medical Specialists

    Memphis, Tennessee, 38125

  • University of Tennessee

    Memphis, Tennessee, 38163

  • Gulf Regional Research and Education Services, LLC

    Metairie, Louisiana, 70002

  • Family Medical Clinic

    Milwaukee, Wisconsin, 53216

  • Internal Medicine Center, LLC

    Mobile, Alabama, 36608

  • Mobile Medical and Diagnostic Center

    Mobile, Alabama, 36617

  • University of South Alabama

    Mobile, Alabama, 36617

  • Berkley Family Practice

    Moncks Corner, South Carolina, 29461

  • Coastal Carolina Health Care, P.A.

    New Bern, North Carolina, 28562

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Medex Healthcare Research, Inc.

    New York, New York, 10036

  • York Clinical Research, LLC

    Norfolk, Virginia, 23510

  • Today Clinical Research, Oklahoma City

    Oklahoma City, Oklahoma, 73129

  • Quality Clinical Research Inc

    Omaha, Nebraska, 68114

  • Sunshine Research Center

    Opa-locka, Florida, 33054

  • Diabetes Associates Medical Group

    Orange, California, 92868

  • Central Florida Internist

    Orlando, Florida, 32811

  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23235

  • Integrated Research Group, Inc.

    Riverside, California, 92506

  • Carolina Cardiology Clinical Research Institute, LLC

    Rock Hill, South Carolina, 29732

  • Laurelton Heart Specialist, PC

    Rosedale, New York, 11422

  • Clinical Trials Research

    Sacramento, California, 95821

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • International Clinical Research - US, LLC

    Sanford, Florida, 32771

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Alternative Solutions Medical Research and Prevention Center

    St. Petersburg, Florida, 33711

  • Eagle's Landing Diabetes and Endocrinology

    Stockbridge, Georgia, 30281

  • Meridien Research

    Tampa, Florida, 33634

  • Orange County Research Center

    Tustin, California, 92780

  • Community Research Partners, Inc

    Varnville, South Carolina, 29944

  • Hillcrest Family Health Center

    Waco, Texas, 76710

  • Mercy Research

    Washington, Missouri, 63090-4700

Other trials in United States

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Empagliflozin (10mg, 25mg) Administered Orally, Once Daily Over 24 Weeks in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus

This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant, new information for the use of empagliflozin.

Essential hypertension is four times more common in African Americans than in Caucasians.

Read more

One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake. There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus.

The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP (DBP) at 12 and 24 weeks.

Being tested
Empagliflozin low dose, placebo, Empagliflozin high dose
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin low doseDrug

    starting dose 10mg; forced titration after 4 weeks 25mg dose

  • placeboDrug

    starting dose 10mg; forced titration after 4 weeks 25mg dose

  • Empagliflozin high doseDrug

    starting dose 10mg; forced titration after 4 weeks 25mg dose

Study groups in NCT02182830
Study groupRoleWhat they receive
EmpagliflozinExperimentalstarting dose 10mg; forced titration after 4 weeks 25mg dose
Receives: Drug: Empagliflozin low dose; Drug: Empagliflozin high dose
PlaceboPlacebo comparatorstarting dose 10mg; forced titration after 4 weeks 25mg dose
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks

    Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.

    Measured: baseline and 24 weeks

Secondary outcomes (10)

  1. Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12

    Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means. This is a key secondary endpoint

    Measured: baseline and 12 weeks

  2. Changes From Baseline in Trough Mean Ambulatory SBP at Week 12

    Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means. This is a key secondary endpoint

    Measured: baseline and 12 weeks

  3. Change From Baseline in Body Weight at Week 24

    Changes from baseline in body weight at Week 24 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means. This is a key secondary endpoint

    Measured: baseline and 24 weeks

  4. Change From Baseline in Trough Seated SBP at Week 12

    Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means. This is a key secondary endpoint

    Measured: baseline and 12 weeks

  5. Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24

    Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means.

    Measured: baseline and 24 weeks

  6. Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12

    Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means.

    Measured: baseline and 12 weeks

  7. Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24

    Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means.

    Measured: baseline and 24 weeks

  8. Change From Baseline in Trough Seated SBP (mmHg) at Week 24

    Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means.

    Measured: baseline and 24 weeks

  9. Change From Baseline in Trough Seated DBP (mmHg) at Week 12

    Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means.

    Measured: baseline and 12 weeks

  10. Change From Baseline in Trough Seated DBP (mmHg) at Week 24

    Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

    Means presented are the adjusted means.

    Measured: baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2014 (estimated)
  2. Study start25 Jul 2014
  3. Primary completion18 May 2017
  4. Study completion18 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02182830
Sponsor's protocol ID
1245.29
Status last verified
Jun 2018
First submitted
3 Jul 2014
Last updated
31 Jul 2018

Publications

  • Ferdinand KC, Harrison D, Johnson A. The NEW-HOPE study and emerging therapies for difficult-to-control and resistant hypertension. Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):64-73. doi: 10.1016/j.pcad.2019.12.008. Epub 2020 Jan 8.

    PubMed 31923435

  • Ferdinand KC, Izzo JL, Lee J, Meng L, George J, Salsali A, Seman L. Antihyperglycemic and Blood Pressure Effects of Empagliflozin in Black Patients With Type 2 Diabetes Mellitus and Hypertension. Circulation. 2019 Apr 30;139(18):2098-2109. doi: 10.1161/CIRCULATIONAHA.118.036568.

    PubMed 30786754

  • Ferdinand KC, Seman L, Salsali A. Design of a 24-week trial of empagliflozin once daily in hypertensive black/African American patients with type 2 diabetes mellitus. Curr Med Res Opin. 2018 Feb;34(2):361-367. doi: 10.1080/03007995.2017.1405800. Epub 2017 Nov 29.

    PubMed 29139301

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin low dose and Empagliflozin high dose in people with Diabetes Mellitus, Type 2 and Hypertension, run by Boehringer Ingelheim at 92 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02182830, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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