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.

"The role of SGLT-2 inhibitors (Empagliflozin) in the management of glucocorticoid induced hyperglycaemia in adults with and without diabetes"

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000745943

Enrollment

Registered

2020-07-20

Start date

2020-10-01

Completion date

2021-10-01

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results