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Trial registered on ANZCTR


Registration number
ACTRN12620000745943p
Ethics application status
Submitted, not yet approved
Date submitted
14/02/2020
Date registered
20/07/2020
Date last updated
20/07/2020
Date data sharing statement initially provided
20/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of SGLT-2 inhibitors (Empagliflozin) in treating steroid induced hyperglycaemia in the management of glucocorticoid induced hypoerglycaemia in adults with and without diabetes.
Scientific title
"The role of SGLT-2 inhibitors (Empagliflozin) in the management of glucocorticoid induced hyperglycaemia in adults with and without diabetes"

Secondary ID [1] 300556 0
Nil known
Universal Trial Number (UTN)
U1111-1248-2984
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Steroid induced hyperglycaemia 316277 0
Condition category
Condition code
Metabolic and Endocrine 314555 314555 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot study.

Participants: Adults who meet the trial inclusion criteria. Participants will be prescribed 10mg tablet of empagliflozin daily, taken orally, for a duration of 4weeks.
Participants will have blood and urine test at the start including Hba1c/ full blood count, serum urea and electrolytes and urine albumin excretion. At the end of the trial similar blood and urine tests will be done.
Participants will email their blood glucose levels every week to the investigators until completion of the trial. Participants will be seen in clinic at the end of the study period and sooner if there are any clinical issues related to treatment.
If participants are not able to complete the study period, any excess medications are returned to the investigators for appropriate disposal
Intervention code [1] 316857 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322877 0
Average time spent within target blood glucose range for each subject.
Each participant will email their blood glucose readings on a weekly basis.
Participants will be expected to monitor their blood glucose levels pre-breakfast and 2 hours post breakfast, lunch and dinner each day. Target blood glucose levels are pre-specified and each week the averages are taken for each pre and post breakfast, post lunch and post dinner readings to determine how many participants meet glycemic control while on empagliflozin therapy.
Timepoint [1] 322877 0
7 days post commencement of intervention
Secondary outcome [1] 380119 0
The number of participants with hypoglycaemia. Hypoglycaemia is a blood glucose level of < 4mmol/L. The participant would document this and inform the investigators via email.
Timepoint [1] 380119 0
Assessed on a weekly basis for 4 weeks but the participant will be able to contact the investigator at any point if concerned about hypoglycaemia
Secondary outcome [2] 380120 0
The number of participants requiring additional insulin therapy. This will be assessed via patient's glucose monitoring records and data collected by researcher on a weekly basis.
Timepoint [2] 380120 0
Assessed on a weekly basis for 4 weeks but participants can contact the investigator sooner if they are concerned.
Secondary outcome [3] 380400 0
Genitourinary infections- participant reports symptoms and are then examined and provided with a urine test to exclude an infection. The clinician will specifically ask for any side-effects during each visit.
Timepoint [3] 380400 0
As Empagliflozin may increase the amount of glucose in the urine for some patients, a urine culture test will be available to patients who present with symptoms of a urinary tract infection during the trial. we will contact the patient on a weekly basis but the participant can contact the investigators at any point during the trial should they develop this complication.
Secondary outcome [4] 380401 0
Euglycaemic diabetes ketoacidosis. This requires hospital admission for treatment as the participant would get sick requiring fluids and potentially insulin infusion. The participant will be admitted to hospital should this happen. The investigators will know about this should the participant be admitted to the research hospitals, otherwise the participant will notify the investigators should this happen as the usual treatment would be ceasing the empagliflozin therapy.
Timepoint [4] 380401 0
Assessed weekly for 4 weeks but the participant can contact the investigators at any point during the trial should they develop this complication.
Secondary outcome [5] 380402 0
Fournier's gangrene incidence- this is a severe but rare complication and usually involves admission to hospital for surgery. This would be reported to the research team should it happen at any point during the trial.
Timepoint [5] 380402 0
Assessed weekly for 4 weeks but the participant can contact the investigators at any point during the trial should they develop this complication.

Eligibility
Key inclusion criteria
Inclusion criteria
Informed consent
Adults aged 18 years old and older
Patients on Glucocorticoid therapy equivalent to 10mg prednisolone or more with planned duration of treatment for at
least 4 weeks
Patients without prior history of diabetes
Patients with pre-existing diabetes on single agent metformin therapy
2 blood glucose readings measuring more than 10mmol/L within a 24 hour period OR
1 random blood glucose reading measuring more than 15mmol/L
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Renal impairment eGFR less than 45ml/minute
Poor oral intake or patient on a low carbohydrate or ketogenic diet
• Patient states that they are actively following a low carbohydrate diet which is
less than 130grams of carbohydrates a day

• Patient states that they are actively following a ketogenic diet which is 20-50grams of carbohydrates a day
Patient with active malignancy
History of recurrent genitourinary infections
Need for ICU admission at the time of recruitment
Current use of SGLT-2 inhibitors
Acute CVA in the past 2/12
Pregnancy/ Breast feeding
Volume depletion at the time of recruitment (gastroenteritis, acute kidney injury, fluid restriction of 1.5litres/day)
Inability to consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable (NA)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 15887 0
Gosford Hospital - Gosford
Recruitment hospital [2] 15888 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 29344 0
2250 - Gosford
Recruitment postcode(s) [2] 29345 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 304965 0
Hospital
Name [1] 304965 0
Department of Endocrinology, Gosford Hospital.
Address [1] 304965 0
Endocrine Department
Gosford Hospital
Holden Street, Gosford
NSW 2250
Country [1] 304965 0
Australia
Primary sponsor type
Hospital
Name
Endocrinology Department, Gosford Hospital
Address
Endocrine Department
Gosford Hospital
Holden Street, Gosford
NSW 2250
Country
Australia
Secondary sponsor category [1] 305330 0
None
Name [1] 305330 0
Address [1] 305330 0
Country [1] 305330 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305376 0
Northern Sydney Local Health District Ethics Commitee
Ethics committee address [1] 305376 0
Research Office, Kolling Institute
Level 13, Kolling Building
Royal North Shore Hospital
reserve Road
St Leonards, NSW, 2065
Ethics committee country [1] 305376 0
Australia
Date submitted for ethics approval [1] 305376 0
21/02/2020
Approval date [1] 305376 0
Ethics approval number [1] 305376 0

Summary
Brief summary
Availability of an oral tablet, empagliflozin (EG) is seen as a potential alternative to insulin injections for elevated glucose levels due to steroid treatment. We aim to investigate this. EG is already widely used for treatment in diabetic patients.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100166 0
Dr Flavian Grace Joseph
Address 100166 0
Endocrine Department
Demountable 1
Gosford Hospital
Holden Street, Gosford,NSW
2250
Country 100166 0
Australia
Phone 100166 0
+610243203266
Fax 100166 0
Email 100166 0
Flavian.Joseph@health.nsw.gov.au
Contact person for public queries
Name 100167 0
Dr Flavian Grace Joseph
Address 100167 0
Endocrine Department
Demountable 1
Gosford Hospital
Holden Street, Gosford, NSW
2250
Country 100167 0
Australia
Phone 100167 0
+61 0243203266
Fax 100167 0
Email 100167 0
Flavian.Joseph@health.nsw.gov.au
Contact person for scientific queries
Name 100168 0
Dr Flavian Grace Joseph
Address 100168 0
Endocrine Department
Demountable 1
Gosford Hospital
Holden Street, Gosford, NSW
2250
Country 100168 0
Australia
Phone 100168 0
+61 0243203266
Fax 100168 0
Email 100168 0
Flavian.Joseph@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not for public. Individual data will be de-identified and thereafter results will be presented in an aggregated way to protect participant privacy
What supporting documents are/will be available?
No other documents available
Summary results
No Results