Type 1 diabetes
uncontrolled diabetes mellitus type 2 with fasting glucose > 13.3 mmol/l confirmed on a second day
known or suspected hypersensitivity to empagliflozin, glimepiride, or any excipients; and / or known or suspected hypersensitivity to sulfonylureas, sulfonamides or SGLT2 inhibitors in general
history of multiple severe hypoglycemic episodes within the last two years
use of Insulin, SGLT2-inhibitor, sulfonylurea derivate or a glinide within past 3 months
clinical significant macular edema in both eyes and indication for intravitreal anti-VEGF treatment for both eyes at screening or baseline visit. Eyes with a small amount of intraretinal or subretinal fluid (seen in OCT) but no need for intravitreal treatment as judged by the investigator (according to current practice patterns) may be included. Eyes with a history of intravitreal treatment of macular edema which do not need ongoing intravitreal treatment at the time of screening may be included.
eye diseases or pathologies that prevent clear ophthalmoscopy and evaluation of study parameters, thus not allowing study participation according to the investigator´s judgment, such as (but not only) vitreous hemorrhage, mature cataract, macular pathologies other than diabetic maculopathy
history of ketoacidosis or metabolic acidosis
use of loop diuretics
history of > 1 urogenital infection/year
any history of stroke, transient ischemic attack (TIA), instable angina pectoris or myocardial infarction within last 3 months prior to baseline visit
congestive heart failure New York Heart Association (NYHA) III and IV
severe valvular or left ventricular outflow obstruction disease needing intervention;
atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute
chronic lower urinary tract infections (but not simple asymptomatic bacteriuria)
eGFR < 60 ml/min/1,73 m2 (MDRD-formula, confirmed on a second day)
chronic diarrhea, any clinical signs of volume depletion or a hematocrit > 48 % (women) and > 53 % (men)
elevated risk for volume depletion, e.g. history of severe volume depletion that required medical therapy
chronic liver disease (including known active hepatitis) and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) > 3 x upper limit of normal (ULN) (confirmed on a second day)
Subjects with known seropositivity to human immunodeficiency virus.
acute illness at screening or randomization according to judgement by the investigator or patient
drug or alcohol abuse
psychosomatic or psychiatric diseases requiring hospitalization during the last 12 months
clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia (5 years prior to randomization)
any medical or surgical intervention planned for the next 13 months after randomization not allowing study participation according to the investigator´s judgment
current participation in any other clinical trial or participation in another clinical trial within 30 days before screening

NCT02985242_exc_T1
Condition
Type 1 diabetes
NCT02985242_exc_T2
Condition
diabetes mellitus type 2
NCT02985242_exc_T3
Qualifier
uncontrolled
NCT02985242_exc_T4
Measurement
fasting glucose
NCT02985242_exc_T5
Value
> 13.3 mmol/l
NCT02985242_exc_T6
Condition
hypersensitivity
NCT02985242_exc_T7
Drug
empagliflozin
NCT02985242_exc_T8
Drug
glimepiride
NCT02985242_exc_T9
Condition
hypersensitivity
NCT02985242_exc_T10
Drug
sulfonylureas
NCT02985242_exc_T11
Drug
sulfonamides
NCT02985242_exc_T12
Drug
SGLT2 inhibitors
NCT02985242_exc_T13
Scope
sulfonylureas, sulfonamides or SGLT2 inhibitors
NCT02985242_exc_T14
Scope
empagliflozin, glimepiride
NCT02985242_exc_T15
Condition
hypoglycemic episodes
NCT02985242_exc_T16
Qualifier
severe
NCT02985242_exc_T17
Multiplier
multiple
NCT02985242_exc_T18
Temporal
last two years
NCT02985242_exc_T19
Drug
Insulin
NCT02985242_exc_T20
Drug
SGLT2-inhibitor
NCT02985242_exc_T21
Drug
sulfonylurea derivate
NCT02985242_exc_T22
Drug
glinide
NCT02985242_exc_T23
Scope
Insulin, SGLT2-inhibitor, sulfonylurea derivate or a glinide
NCT02985242_exc_T24
Temporal
past 3 months
NCT02985242_exc_T25
Condition
macular edema
NCT02985242_exc_T26
Qualifier
both eyes
NCT02985242_exc_T27
Procedure
intravitreal anti-VEGF treatment
NCT02985242_exc_T28
Qualifier
both eyes
NCT02985242_exc_T30
Negation
prevent
NCT02985242_exc_T31
Procedure
ophthalmoscopy
NCT02985242_exc_T32
Condition
vitreous hemorrhage
NCT02985242_exc_T33
Condition
mature cataract
NCT02985242_exc_T34
Condition
macular pathologies
NCT02985242_exc_T35
Negation
other
NCT02985242_exc_T36
Condition
diabetic maculopathy
NCT02985242_exc_T37
Condition
ketoacidosis
NCT02985242_exc_T38
Condition
metabolic acidosis
NCT02985242_exc_T39
Drug
loop diuretics
NCT02985242_exc_T40
Condition
urogenital infection
NCT02985242_exc_T41
Multiplier
nit  his
NCT02985242_exc_T42
Condition
stroke
NCT02985242_exc_T43
Condition
transient ischemic attack
NCT02985242_exc_T44
Condition
TIA
NCT02985242_exc_T45
Condition
angina pectoris
NCT02985242_exc_T46
Qualifier
instable
NCT02985242_exc_T47
Condition
myocardial infarction
NCT02985242_exc_T48
Temporal
last 3 months prior to baseline visit
NCT02985242_exc_T49
Reference_point
baseline visit
NCT02985242_exc_T50
Scope
stroke, transient ischemic attack (TIA), instable angina pectoris or myocardial infarction
NCT02985242_exc_T51
Condition
congestive heart failure
NCT02985242_exc_T52
Measurement
New York Heart Association
NCT02985242_exc_T53
Measurement
NYHA
NCT02985242_exc_T54
Value
III and IV
NCT02985242_exc_T55
Condition
left ventricular outflow obstruction
NCT02985242_exc_T56
Condition
left ven ing int
NCT02985242_exc_T57
Qualifier
severe
NCT02985242_exc_T58
Scope
valvular or left ventricular outflow obstruction disease
NCT02985242_exc_T59
Procedure
intervention
NCT02985242_exc_T60
Condition
atrial fibrillation
NCT02985242_exc_T61
Condition
lation a mean
NCT02985242_exc_T62
Measurement
mean ventricular response rate
NCT02985242_exc_T63
Qualifier
at rest
NCT02985242_exc_T64
Value
>100 beats per minute
NCT02985242_exc_T65
Scope
atrial fibrillation/flutter
NCT02985242_exc_T66
Condition
lower urinary tract infections
NCT02985242_exc_T67
Qualifier
chronic
NCT02985242_exc_T68
Negation
not
NCT02985242_exc_T69
Condition
asymptomatic bacteriuria
NCT02985242_exc_T70
Measurement
eGFR
NCT02985242_exc_T71
Value
< 60 ml/min/1,73 m2
NCT02985242_exc_T72
Condition
chronic diarrhea
NCT02985242_exc_T73
Condition
volume depletion
NCT02985242_exc_T74
Measurement
hematocrit
NCT02985242_exc_T75
Value
> 48 %
NCT02985242_exc_T76
Person
women
NCT02985242_exc_T77
Value
> 53 %
NCT02985242_exc_T78
Person
men
NCT02985242_exc_T79
Measurement
hematocrit
NCT02985242_exc_T80
Scope
hematocrit > 48 % (women) and > 53 % (men)
NCT02985242_exc_T81
Observation
risk for volume depletion,
NCT02985242_exc_T82
Qualifier
elevated
NCT02985242_exc_T83
Condition
chronic liver disease
NCT02985242_exc_T84
Condition
active hepatitis
NCT02985242_exc_T85
Measurement
alanine transaminase
NCT02985242_exc_T86
Measurement
ALT
NCT02985242_exc_T87
Measurement
aspartate transaminase
NCT02985242_exc_T88
Measurement
AST
NCT02985242_exc_T89
Value
> 3 x upper limit of normal
NCT02985242_exc_T90
Scope
alanine transaminase (ALT) or aspartate transaminase (AST)
NCT02985242_exc_T91
Measurement
human immunodeficiency virus
NCT02985242_exc_T92
Value
seropositivity
NCT02985242_exc_T94
Condition
alcohol abuse
NCT02985242_exc_T95
Condition

ps r psy
NCT02985242_exc_T96
Condition
psychiatric diseases
NCT02985242_exc_T97
Condition
iatric diseas pitaliza
NCT02985242_exc_T98
Visit
hospitalization
NCT02985242_exc_T99
Temporal
last 12 months
NCT02985242_exc_T100
Scope
psychosomatic or psychiatric diseases
NCT02985242_exc_T101
Condition
malignancy
NCT02985242_exc_T102
Negation
exception
NCT02985242_exc_T103
Condition
cell carci and cervi al intraepi
NCT02985242_exc_T104
Condition
squamous cell carcinoma of the skin
NCT02985242_exc_T105
Condition
cervical intraepithelial neoplasia
NCT02985242_exc_T106
Temporal
5 years prior to randomization
NCT02985242_exc_T107
Reference_point
randomization
NCT02985242_exc_T108
Scope
basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia