women and men between 18 - 80 years of age
type 2 diabetes mellitus
early to moderate stage diabetic retinopathy (ETDRS: 20 (microaneurysms only) to 35 (microaneurysms/ hemorrhages and/or hard exsudates)) in one or both eyes
stable HbA1c (± 0.5%) for at least 12 weeks
antidiabetic treatment with either diet, metformin, DPP4, GLP1, pioglitazone, acarbose, or respective combinations
HbA1c = 6.5 and = 10.0 %
body mass index < 46 kg/m2
office blood pressure = 150/95 mmHg (confirmed on a second day; 24h ambulatory blood pressure measurement (ABPM) is allowed to check accuracy of office values; inclusion with 24h mean blood pressure = 145/90 mm Hg is possible); patients with hypertension should be treated according to current treatment guidelines
at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy
hysterectomy
= 50 years and in postmenopausal state > 1 year
< 50 years and in postmenopausal state > 1 year with serum follicle stimulating hormone (FSH) > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening or women of childbearing potential with a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of 4 days following the last administration of study medication:
correct use of one of the following accepted contraception methods: hormonal contraceptives (combined oral contraceptives, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUD/IUS) or a double barrier method, e.g. condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
sexual relationship only with female partners
sterile male partners
signed written informed consent and willingness to comply with treatment and follow-up procedures
capability of understanding the investigational nature, potential risks and benefits of the clinical trial

NCT02985242_inc_T1
Person
women
NCT02985242_inc_T2
Person
men
NCT02985242_inc_T3
Person
age
NCT02985242_inc_T4
Value
between 18 - 80 years
NCT02985242_inc_T5
Condition
type 2 diabetes mellitus
NCT02985242_inc_T6
Condition
diabetic retinopathy
NCT02985242_inc_T7
Qualifier
early
NCT02985242_inc_T8
Qualifier
moderate stage
NCT02985242_inc_T9
Scope
early to moderate stage
NCT02985242_inc_T10
Measurement
ETDRS
NCT02985242_inc_T11
Value
20
NCT02985242_inc_T12
Value
35
NCT02985242_inc_T13
Scope
20 (microaneurysms only) to 35
NCT02985242_inc_T14
Qualifier
eyes
NCT02985242_inc_T15
Measurement
HbA1c
NCT02985242_inc_T16
Value
± 0.5%
NCT02985242_inc_T17
Temporal
at least 12 weeks
NCT02985242_inc_T18
Procedure
antidiabetic treatment
NCT02985242_inc_T19
Observation
diet
NCT02985242_inc_T20
Drug
metformin
NCT02985242_inc_T21
Drug
DPP4
NCT02985242_inc_T22
Drug
GLP1
NCT02985242_inc_T23
Drug
pioglitazone
NCT02985242_inc_T24
Drug
acarbose
NCT02985242_inc_T25
Scope
diet, metformin, DPP4, GLP1, pioglitazone, acarbose
NCT02985242_inc_T26
Measurement
HbA1c
NCT02985242_inc_T27
Value
= 6.5 and = 10.0 %
NCT02985242_inc_T28
Person
body mass index
NCT02985242_inc_T29
Value
< 46 kg/m2
NCT02985242_inc_T30
Measurement
blood pressure
NCT02985242_inc_T31
Value
= 150/95 mmHg
NCT02985242_inc_T33
Procedure
surgical sterilization
NCT02985242_inc_T34
Procedure
bilateral tubal ligation
NCT02985242_inc_T35
Procedure
bilateral oophorectomy
NCT02985242_inc_T36
Scope
bilateral tubal ligation or bilateral oophorectomy
NCT02985242_inc_T37
Temporal
at least 6 weeks
NCT02985242_inc_T38
Procedure
hysterectomy
NCT02985242_inc_T39
Person
years
NCT02985242_inc_T40
Value
= 50
NCT02985242_inc_T41
Observation
postmenopausal state
NCT02985242_inc_T42
Temporal
> 1 year