None listed
Conditions
Brief summary
Cardiovascular disease and its risk factors are prominent issues in T1D. There is a need to identify therapies that can address weight, glycaemia and other cardiometabolic indices in T1D. In T1D, whether tirzepatide, a dual gastric inhibitory polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist improves weight, glycaemia and cardiometabolic health has not been previously studied. The TIRTLE study is a randomised controlled clinical trial in adults with type 1 diabetes.
Interventions
subcutaneous tirzepatide injection 2.5mg once weekly for 4 weeks, then 5.0mg once weekly (or maximum tolerated dose) for 12 weeks post initiation of treatment
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• age 18-60 years • 2 years since diagnosis of type 1 diabetes • BMI greater than or equal to 30 kg/m2 • Willingness to give written informed consent, participate and comply with the study.
Exclusion criteria
• treatment with a glucagon-like peptide-1 (GLP1) receptor agonist, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor in the last 6 weeks • treatment with glucocorticoids in the last 6 weeks • previous bariatric surgery or planned during the trial period • diabetic ketoacidosis or severe hypoglycaemia in the last 3 months • eGFR <45 ml/min/1.73m2 • evidence of significant liver disease (known cirrhosis, LFTs > 3x upper limit of normal) • known gastroparesis • history of pancreatitis or cholecystitis • pregnant, breastfeeding or female of childbearing potential not using adequate contraception • coronary event or stroke in the last 3 months • history of active proliferative diabetic retinopathy or macular oedema • cognitive impairment or significant psychiatric illness which impairs ability to understand study requirements
Outcome results
None listed