None listed
Conditions
Brief summary
Empagliflozin is used to treat type 2 diabetes. It works by promoting loss of glucose in the urine. Recent evidence suggests this drug might help preserve pancreas function in people with diabetes. This study will assess the feasibility and safety of this approach in people who are within 100 days of being diagnosed with type 1 diabetes.
Interventions
Empagliflozin 25mg orally daily for 6 months. Compliance will be monitored by assessing drug packets returned.
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Age between 18 and 40 years at time of consent Type 1 diabetes diagnosed within 100 days of the month 0 visit with antibodies against at least one of the GAD, IA2, ZnT8 or insulin antigens, measured by an accredited clinical laboratory Demonstrated ability to comply with insulin prescription and to record home glucose readings at least four times a day A meal-stimulated C-peptide >0.07nmol/l (>0.2ng/ml)
Exclusion criteria
Contra-indication to empagliflozin Serious co-morbidity deemed by the study clinician to pose unacceptable risk Unwilling to accept the rigors of the study, including four meal tolerance tests and frequent sustained periods of home glucose and ketone monitoring If female: pregnancy, breast feeding or a desire for pregnancy during the study If female with reproductive potential, refusal to use contraception during the study
Outcome results
None listed