None listed
Conditions
Brief summary
Cystic fibrosis related diabetes (CFRD) is the most common comorbidity in cystic fibrosis (CF), and is primarily managed with insulin. Evidence for use of adjunctive agents used in other forms of diabetes have been relatively less well studied in CFRD. Sodium-glucose cotransporter 2 inhibitors (SLGT2i) may have benefits to management of CFRD alongside metabolic and respiratory benefits in CF. This will be a randomised placebo controlled trial of empagliflozin 10 mg in those with CFRD. Outcomes will be an assessment of glycaemia including HbA1c, as well as BMI and respiratory outcomes.
Interventions
Randomised controlled trial of empagliflozin 10 mg daily oral tablet, duration 6 months. Adherence monitored via drug tablet return.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 or older, with a documented diagnosis of cystic fibrosis Documented diagnosis of CFRD Women of child bearing potential must agree to take precautions to prevent pregnancy (including abstinence from sexual intercourse, hormonal contraception)
Exclusion criteria
Current use of a SGLT2i or used in the past 4 weeks Previous intolerance to SGLT2i Type 1 diabetes Positive GAD 65 antibody or low fasting C-peptide if previously performed (below the reference range of the lab) History of diabetic ketoacidosis (DKA) Previous severe hypoglycaemic events with hypoglycaemic unawareness History of recurrent genital or urinary tract infections Pregnancy or lactation BMI 7.5 mg daily) in the month prior
Outcome results
None listed