Diabetes Mellitus that is induced by the use of glucocorticoids MedDRA version: 20.0 Level: LLT Classification code 10012628 Term: Diabetes steroid-induced System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Jardiance
Pharmaceutical Form:
INN or Proposed INN: empagliflozin
CAS Number: 864070-44-0
Other descriptive name: EMPAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Nordsjællands Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
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). 10.Involvement in the planning/or conduct of the study 11.Previous randomisation in the study 12.Participation in another study with an investigational product during the last 30 days prior to enrolment 13. Age > 85 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if empagliflozin can be used as a safe alternative to NPH insulin in patients with GIDM, with a tolerated significant difference in mean daily glucose (mean of CGM measurements) of up to 3mmol/L to the higher side. ;Secondary Objective: To determine if Empagliflozin is non-inferior compared with NPH insulin in treating GIDM. ;Primary end point(s): Mean glucose difference between the empagliflozin and NPH insulin group (calculated mean of CGM glucose profiles over the 2 first weeks of treatment). The data will be downloaded directly from the patients CGM sensors. For calibration purposes capillary glucoses are to be taken: 1) morning fasting and 2) postprandial dinner. The values will be written down by the patient in a study diary. 70 % of possible data (10 out of 14 days) should be available for the patient to be included in the statistical analysis. ;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated after the end of the trial period which is a minimum of 30 days after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Between group differences in Time spent In Range (TIR) Between group differences of time glucose is above range Between group differences of time glucose is below range Between group differences in AUC for blood glucose during periods when blood glucose levels reach hyperglycemia level 1 2 and 3*. Between group differences in AUC for blood glucose during periods when blood glucose levels reach hypoglycemia level 1 and 2*. Between group differences in mean daytime blood glucose levels Between group differences in mean nocturnal blood glucose levels Between group differences in eHBA1c Between group differences in SD of 24-hour blood glucose values Between group differences in the SD of daytime blood glucose values Between group differences in SD of nocturnal blood glucose values Between group differences of MAGE (mean amplitude of glycemic excursions) Between group difference in glucose variability measured by the coefficient of variation (CV) Between group differences in number of hypoglycemic events* in total and divided into levels and nighttime/daytime Between group differences in number of hyperglycemic events* in total and divided into levels and nighttime/daytime Number of patients in each group that reach a daily mean glucose level of 6-12 mmol/L during treatment for at least 7 out of the first 14 days of treatment. Outcome measure: CGM and SMBG mean glucose levels Mean plasma glucose difference between the empagliflozin and NPH insulin group Number of events of mild hypoglycaemia and severe hypoglycaemia (need for third party assistance to restore blood glucose) ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after the end of the trial period which is a minimum of 30 days after inclusion. | — |
Countries
Denmark
Contacts
Public ContactPeter Lommer Kristensen
Nordsjællands Hospital
Outcome results
None listed