None listed
Conditions
Brief summary
Type-2 diabetes (T2DM), a disease of abnormal blood sugar control, is known to contribute to poor immune function, impaired wound healing and increased risk of heart disease, kidney disease and stroke. When patients who have T2DM are admitted to intensive care they receive a range of routine therapies to support their condition. However, the effectiveness of these current therapies is affected by abnormal blood sugar levels and it would be desirable to restore a normal blood state quickly. Over the last few years, evidence has emerged that Dapagliflozin, a blood sugar lowering drug that can be administered as a tablet, may help to return blood sugar levels to normal with minimal or no side effects. This drug has also been shown to slow the progression of heart and kidney related complications of diabetes. This makes treatment with Dapagliflozin potentially desirable in patients with T2DM who are admitted to the intensive care unit. However, the effect of Dapagliflozin in such complex and very sick patients has not yet been studied. For this reason, we are planning to perform a clinical research project, known as a randomised controlled trial. We aim to evaluate whether giving oral Dapagliflozin (10mg daily for up to 28-days while in ICU) compared to placebo (a dummy tablet), normalises blood sugar levels and \ or decreases the need for insulin in 40 patients with T2DM admitted to intensive care. Importantly, should our findings demonstrate safety and potential benefit, it will allow this treatment to be studied in larger groups and, perhaps become a standard of care for the many patients with T2DM who are admitted to the intensive care unit each year in Australia and potentially worldwide.
Interventions
Once daily oral administration of 10mg Dapagliflozin for a maximum of 28 days from the time of enrolment while the participant is admitted to the intensive care unit with adherence of study intervention via audit of hospital medication charts.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult aged 18 years or greater Expected to be admitted to the ICU until the day after tomorrow Pre-existing diagnosis of Type-2 diabetes mellitus Estimated Glomerular Filtration rate (eGFR) of less than 45 ml/min/1.73m2 Able to take medication enterically
Exclusion criteria
Diagnosis of Type-1 diabetes mellitus (T1DM) Documented SGLT2 inhibitor intolerance Hepatic impairment with aspartate transaminase [AST] or alanine transaminase [ALT] greater than 3x the upper limit of normal [ULN]; or total bilirubin greater than 2x ULN at time of enrolment No enteric route for medication administration Pregnancy Death is deemed to be imminent or inevitable during this admission Patients with diabetic ketoacidosis Pre-existing urinary tract infection Hypernatraemia defined as a serum sodium levels equal to or greater than 150 mmol/L at the time of screening Clinician deems enrolment in the study is not in the patient’s best interests
Outcome results
None listed