Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity

Korábbi kezelés

• Not willing to use a NovoPen 6 to record insulin dosing if currently using multiple daily injections
• Current use of any steroidal medication, or planned long-term steroidal treatment (>4 weeks) during the study period
• Have a pacemaker, or metal implants

Más betegség

• A clinical diagnosis of diabetes type other than T1D
• History of hypersensitivity to investigational medicinal product or related product
• Obesity that is induced by other endocrine disorders
• History of chronic or acute pancreatitis, uncontrolled hypertension, acute cardiovascular condition within 3 months
• History of or plans for bariatric surgery during the study period
• History of severe hypoglycaemia (within 3 months of trial period)
• History of diabetic ketoacidosis (within 3 months of trial period)
• History of stroke (within 3 months of trial period)
• History of heart failure
• History of acute or chronic liver disease
• History of allergy to any form of insulin, GLP-1RA or its excipients
• History of malignancy requiring chemotherapy, surgery, or radiation (within 5 years of trial period)
• History of multiple endocrine neoplasia type 2, familial thyroid cancer, or non-familial medullary thyroid cancer
• Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening
• Existence of any additional health conditions or medical issues, including significant psychiatric disorders, that render a person unfit for the study at the discretion of the investigators

Laborértékek

• HbA1c > 10%
• Use of any glucose lowering medications aside from insulin within 1 month of study screening
• Serum triglycerides >500 mg/dL
• eGFR <45 ml/min/1.73 m2

Életkor

• Age <18 years and >70 years

Egyéb

• Use of GLP-1 receptor agonist within 1 month of study screening
• Pregnancy or positive pregnancy test at time of screening, or unwilling to use effective contraception consistently for the duration of the study which is defined in Appendix 1
• Active proliferative diabetic retinopathy, maculopathy, or severe no proliferative diabetic retinopathy requiring acute treatment
• Known gastric emptying abnormality
• No longer than 12 months of insulin treatment
• Insulin pump, CGM or smart phone devices are not compatible for data transfer
• Not willing to share device data
• Planned coronary, carotid, or peripheral artery revascularisation
• Participation in other intervention trials during the study period

• Age 18-70 years at screening
• A clinical diagnosis of T1D for at least 12 months at time of screening
• Body mass index ≥ 27kg/m2
• HbA1c ≤ 10%
• Capable and willing to self-inject tirzepatide once per week
• In women of childbearing potential, a negative pregnancy test and willing to use effective contraception consistently for the duration of the study
• Able and willing to provide written informed consent for study participation
• Able and willing to use Easy Diet Diary
• Able and willing to keep an exercise log
• Willing to share devices data uploads
• Has current glucagon product to treat severe hypoglycaemia
• Has current ketone meters to check ketones