SGLT2-inhibition with Empagliflozin reduces progression of diabetic retinopathy in patients with high risk of diabetic macular edema (The SUPER-Trial) - Empagliflozin and microangiopathy

Hannover Medical School0 sites80 target enrollmentJuly 29, 2016

Overview

No summary available.

Registry

who.int

Start Date

July 29, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.women and men between 18 \- 80 years of age
•2\.type 2 diabetes mellitus
•3\.early to moderate stage diabetic retinopathy (ETDRS: 20 (microaneurysms only) to 35 (microaneurysms/emorrhages and/or hard exsudates) in one or both eyes
•4\.stable HbA1c (± 0\.5%) for at least 12 weeks
•5\.antidiabetic treatment with either diet, metformin, DPP4, GLP1, pioglitazone, acarbose, or respective combinations
•6\.HbA1c \= 6\.5 and \= 10\.0 %
•7\.body mass index \< 46 kg/m2
•8\.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
•9\.either women without childbearing potential defined by:
•oat least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy

•1\.Type 1 diabetes
•2\.uncontrolled diabetes mellitus type 2 with fasting glucose \> 13\.3 mmol/l confirmed on a second day
•3\.known or suspected hypersensitivity to empagliflozin, glimepiride, or any excipients; and / or known or suspected hypersensitivity to sulfonylureas, sulfonamides or SGLT2 inhibitors in general
•4\.history of multiple severe hypoglycemic episodes within the last two years
•5\.use of Insulin, SGLT2\-inhibitor, sulfonylurea derivate or a glinide within past 3 months
•6\.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.
•7\.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
•8\.history of ketoacidosis or metabolic acidosis
•9\. use of loop diuretics
•10\.history of \> 1 urogenital infection/year