Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide) within the last three months prior to Screening
Repeated episodes of severe hypoglycaemia within the last six months prior to Screening
History of diabetic ketoacidosis, precoma diabetica, or diabetic coma
Treatment with any other investigational drug within the last three months before Screening
Acute infections within the last four weeks prior to Screening
Recurrent urogenital infections
History of pancreatitis
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
History of severe or multiple allergies
Concomitant participation in other clinical trials
Type 1 diabetes
Cardiovascular disease Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs. Percutaneous coronary intervention within the past 6 months. Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery; unstable angina; or stroke.
Malignancy including leukemia and lymphoma within the last 5y.
Liver disease such as cirrhosis or chronic active hepatitis.
Significant renal dysfunction (see also exclusion criteria laboratory abnormalities).
State after kidney transplantation
Endocrine disease:
Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening
History of active substance abuse (including alcohol > 40g/day) within the past 2 years.
Pregnancy or childbearing potential without adequate contraception
Present therapy with systemic steroids
Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI's (selective serotonin reuptake inhibitor)
Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study.
Contraindications for Magnetic resonance (MR) scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia

NCT02965443_exc_T1
Procedure
oral antidiabetic treatment
NCT02965443_exc_T2
Drug
oral antidiabetic
NCT02965443_exc_T3
Negation
except for
NCT02965443_exc_T4
Drug
metformin
NCT02965443_exc_T5
Drug
sulphonylureas
NCT02965443_exc_T6
Drug
DPP-IV inhibitors
NCT02965443_exc_T7
Drug
thiazolidinediones
NCT02965443_exc_T8
Drug
SGLT-2 inhibitors
NCT02965443_exc_T9
Drug
GLP-1 analogues
NCT02965443_exc_T10
Temporal
within the last three months prior to Screening
NCT02965443_exc_T11
Reference_point
Screening
NCT02965443_exc_T12
Scope
sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide)
NCT02965443_exc_T13
Scope
oral antidiabetic treatment except for metformin
NCT02965443_exc_T14
Multiplier
Repeated
NCT02965443_exc_T15
Condition
severe hypoglycaemia
NCT02965443_exc_T16
Temporal
within the last six months prior to Screening
NCT02965443_exc_T17
Reference_point
Screening
NCT02965443_exc_T18
Condition
diabetic ketoacidosis
NCT02965443_exc_T19
Observation
History
NCT02965443_exc_T20
Condition
precoma diabetica
NCT02965443_exc_T21
Condition
diabetic coma
NCT02965443_exc_T22
Scope
diabetic ketoacidosis, precoma diabetica, or diabetic coma
NCT02965443_exc_T23
Drug
investigational drug
NCT02965443_exc_T24
Procedure
Treatment
NCT02965443_exc_T25
Temporal
within the last three months before Screening
NCT02965443_exc_T26
Reference_point
Screening
NCT02965443_exc_T27
Condition
Acute infections
NCT02965443_exc_T28
Temporal
within the last four weeks prior to Screening
NCT02965443_exc_T29
Reference_point
Screening
NCT02965443_exc_T30
Multiplier
Recurrent
NCT02965443_exc_T31
Condition
urogenital infections
NCT02965443_exc_T32
Observation
History
NCT02965443_exc_T33
Condition
pancreatitis
NCT02965443_exc_T34
Observation
Anamnestic history
NCT02965443_exc_T35
Condition
hypersensitivity
NCT02965443_exc_T36
Drug
study drugs
NCT02965443_exc_T37
Drug
drugs with similar chemical structures
NCT02965443_exc_T38
Scope
study drugs or to drugs with similar chemical structures
NCT02965443_exc_T39
Condition
allergies
NCT02965443_exc_T40
Qualifier
severe
NCT02965443_exc_T41
Qualifier
multiple
NCT02965443_exc_T42
Scope
severe or multiple
NCT02965443_exc_T43
Observation
History
NCT02965443_exc_T44
Temporal
Concomitant
NCT02965443_exc_T45
Observation
participation in other clinical trials
NCT02965443_exc_T46
Condition
Type 1 diabetes
NCT02965443_exc_T47
Condition
Cardiovascular disease
NCT02965443_exc_T48
Qualifier
Clinically relevant
NCT02965443_exc_T49
Condition
ventricular tachycardia
NCT02965443_exc_T50
Condition
ventricular fibrillation
NCT02965443_exc_T51
Condition
3rd degree AV block
NCT02965443_exc_T52
Condition
Torsades de Pointes
NCT02965443_exc_T53
Procedure
treatment
NCT02965443_exc_T54
Drug
antiarrhythmic drugs
NCT02965443_exc_T55
Procedure
Percutaneous coronary intervention
NCT02965443_exc_T56
Temporal
within the past 6 months
NCT02965443_exc_T57
Scope
ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs
NCT02965443_exc_T58
Temporal
within the past 6 months
NCT02965443_exc_T59
Condition
myocardial infarction (MI)
NCT02965443_exc_T60
Procedure
coronary artery bypass surgery
NCT02965443_exc_T61
Condition
unstable angina
NCT02965443_exc_T62
Condition
stroke
NCT02965443_exc_T63
Scope
myocardial infarction (MI), coronary artery bypass surgery; unstable angina; or stroke
NCT02965443_exc_T64
Scope
Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs. Percutaneous coronary intervention within the past 6 months. Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery; unstable angina; or stroke
NCT02965443_exc_T65
Condition
Malignancy
NCT02965443_exc_T66
Condition
leukemia
NCT02965443_exc_T67
Condition
lymphoma
NCT02965443_exc_T68
Temporal
within the last 5y
NCT02965443_exc_T69
Scope
leukemia and lymphoma
NCT02965443_exc_T70
Condition
Liver disease
NCT02965443_exc_T71
Condition
cirrhosis
NCT02965443_exc_T72
Condition
chronic active hepatitis
NCT02965443_exc_T73
Scope
cirrhosis or chronic active hepatitis
NCT02965443_exc_T74
Qualifier
Significant
NCT02965443_exc_T75
Condition
renal dysfunction
NCT02965443_exc_T77
Condition
State after kidney transplantation
NCT02965443_exc_T78
Procedure
kidney transplantation
NCT02965443_exc_T79
Condition
Endocrine disease
NCT02965443_exc_T80
Measurement
Systolic blood pressure
NCT02965443_exc_T81
Value
outside the range of 100-160 mmHg
NCT02965443_exc_T82
Measurement
diastolic blood pressure
NCT02965443_exc_T83
Value
above 95 mmHg
NCT02965443_exc_T84
Temporal
at Screening
NCT02965443_exc_T85
Scope
Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg
NCT02965443_exc_T87
Observation
History
NCT02965443_exc_T88
Qualifier
active
NCT02965443_exc_T89
Condition
substance abuse
NCT02965443_exc_T90
Measurement
alcohol
NCT02965443_exc_T91
Value
> 40g/day
NCT02965443_exc_T92
Scope
alcohol > 40g/day
NCT02965443_exc_T93
Temporal
within the past 2 years
NCT02965443_exc_T94
Condition
Pregnancy
NCT02965443_exc_T95
Observation
childbearing potential
NCT02965443_exc_T96
Negation
without
NCT02965443_exc_T97
Qualifier
adequate
NCT02965443_exc_T98
Procedure
contraception
NCT02965443_exc_T99
Procedure
therapy
NCT02965443_exc_T100
Temporal
Present
NCT02965443_exc_T101
Drug
systemic steroids
NCT02965443_exc_T102
Condition
psychiatric disorder
NCT02965443_exc_T103
Drug
ti-psychotic ag tion o
NCT02965443_exc_T104
Drug
anti-psychotic agents
NCT02965443_exc_T105
Negation
with the exception of
NCT02965443_exc_T106
Drug
benzodiazepines
NCT02965443_exc_T107
Drug
SSRIs
NCT02965443_exc_T108
Drug
SNRI's
NCT02965443_exc_T109
Scope
benzodiazepines and SSRIs/SNRI's
NCT02965443_exc_T110
Scope
anti-depressive or anti-psychotic agents
NCT02965443_exc_T111
Scope
anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI's
NCT02965443_exc_T112
Observation
unreliable subjects
NCT02965443_exc_T114
Observation
unsuitable for the study
NCT02965443_exc_T116
Condition
Contraindications
NCT02965443_exc_T117
Procedure
Magnetic resonance (MR) scanning
NCT02965443_exc_T118
Device
cardiac pacemaker
NCT02965443_exc_T119
Device
implants out of metal
NCT02965443_exc_T120
Condition
claustrophobia
NCT02965443_exc_T121
Scope
Contraindications for Magnetic resonance (MR) scanning
NCT02965443_exc_T122
Scope
cardiac pacemaker and implants out of metal or claustrophobia