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

Inclusion criteria:

- 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

- 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

Exclusion criteria:

- 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.

- 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.