A randomized, controlled, multicentre trial regarding the safety and feasibility of treatment with empagliflozin compared with NPH insulin treatment in patients with newly onset diabetes following initiation of glucocorticoid treatment. - EANITIATE

ordsjællands Hospital0 sites74 target enrollmentSeptember 13, 2018

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 13, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ordsjællands Hospital

Eligibility Criteria

Inclusion Criteria

•1\.Written signed informed consent prior to any study specific procedures
•2\.Recent (within a week) diagnosis of GIDM (defined as non\-fasting plasma glucose measured \> 11\.1 mmol/l at two different occasions, OR at one occasion above 11\.1 mmol/L with classical hyperglycaemia symptoms, OR a fasting plasma glucose of \>7 mmol/L).
•3\.Hospitalized at the time of screening.
•4\.Patients \>18 years at the time of consent.
•5\.eGFR \= 60 ml/min/1\.73 m2 (estimated by CKD\-EPI formula) at visit 1
•6\.Female patients must use contraception. The following contraceptives are considered as safe contraception in drug trials: Intra\-uterine\-device or hormonal contraception (birth control pills, implant, transdermal patch, vaginal ring or depot injection). Sterile or non\-fertile subjects are exempted from the requirement for contraception. In order to be considered sterile or non\-fertile, one must generally be surgically sterilized (bilateral oophorectomy or hysterectomised at least six months prior to screening) or be postmenopausal, defined as non\-menstrual period for at least 12 months before studying. For some individuals or special populations, there may be relationships that speak against the use of the above methods. Examples may be severely impaired hospitalized patients. Such an assessment is taken by the investigator and is his responsibility
•7\.Must be able to communicate with the study personnel.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•Exclusion criteria
•1\.Known diabetes (treated or not treated) prior to initiation of glucocorticoid treatment.
•2\.Use of any blood glucose\-lowering medication for the last 30 days prior to the trial for any reason, except up to 2 doses of insulin prior to screening
•3\.Hyperglycaemia with a glucose level \>20mmol/L
•4\.Any former or ongoing pancreatic disorder.
•5\.Known or suspected hypersensitivity to trial product(s) or products with the same content/known cross\-reactivity.
•6\.Females of childbearing potential who are pregnant, breast\-feeding, intend to become pregnant or are not using adequate contraceptive methods.
•7\.The receipt of any investigational product 30 days prior to this trial
•8\.Known or suspected abuse of alcohol or drugs.
•9\.Suspected non\-compliance with the protocol (as judged by the investigator).