Renal effects of treatment with Empagliflozin alone or in combination with Semaglutide in patients with type 2 diabetes and albuminuria- A double blinded, randomised, placebo controlled, parallel, single center study - EmpaSema

Steno Diabetes Center Copenhagen0 sites80 target enrollmentOctober 2, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 2, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Given written informed consent
•2\.Male or female patients \= 18 years with type 2 diabetes (WHO criteria).
•3\.UACR \> 100 mg/g within a year of informed consent documented in the medical files.
•4\.eGFR \= 30 ml/min/1\.73 m2 (estimated by CKD\-EPI formula) within 3 months of informed consent documented in the medical files. The eGFR measured at visit 0 has to meet the criteria as well.
•5\.Fertile female must use chemical, hormonal and mechanical contraceptives, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening
•6\.Treated with maximal tolerated dose of an angiotensin\-converting\-enzyme inhibitor or an angiotensin II receptor blocker, 4 weeks prior to randomisation. If the participants are not treated with maximal tolerated dosis the investigator will increase the dose 4 weeks prior randomisation if tolerated.
•7\.Ability to communicate with the investigator and understand informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\.Type 1 diabetes
•2\.Known or suspected hypersensitivity to trial product(s) or related products
•3\.Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
•4\.Cardiac disease defined as: Decompensated heart failure (NYHA class III\-IV) and or diagnosis of unstable angina pectoris and/or myocadial infarction within the last 6 months.
•5\.Previous bowel resection
•6\.Body mass index \< 18\.5 kg/m2
•7\.Females of childbearing potential who are pregnant, breast\-feeding, intend to become pregnant or are not using adequate contraceptive methods
•8\.Known or suspected abuse of alcohol or narcotics.
•9\.Participant in another intervention study