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

Launched by ROYAL NORTH SHORE HOSPITAL · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tirzepatide to see if it can help people with Type 1 Diabetes (T1D) who are also overweight or obese. The trial will involve 40 participants who will be randomly assigned to either receive insulin treatment alone or insulin plus tirzepatide for 32 weeks. The main goal is to find out if adding tirzepatide can help reduce body weight and improve blood sugar control in these patients compared to those who only receive insulin. Participants will also be monitored for 6 months after the treatment to see how they continue to do.

To join the trial, participants need to be between 18 and 70 years old, diagnosed with T1D for at least a year, and have a body mass index (BMI) of 27 or higher. They should also be able to self-inject tirzepatide once a week and be willing to keep track of their diet and exercise. However, there are some restrictions, such as not having other types of diabetes, certain health conditions, or recent treatments that could affect the study. If eligible, participants can expect regular check-ins and support throughout the trial, as well as the opportunity to contribute to important research that could improve treatment options for those with T1D and obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Age \<18 years and \>70 years
• • A clinical diagnosis of diabetes type other than T1D
• • HbA1c \> 10%
• • Use of GLP-1 receptor agonist within 1 month of study screening
• • Use of any glucose lowering medications aside from insulin within 1 month of study screening
• • History of hypersensitivity to investigational medicinal product or related product
• • Obesity that is induced by other endocrine disorders
• • 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
• • History of chronic or acute pancreatitis, uncontrolled hypertension, acute cardiovascular condition within 3 months
• • No longer than 12 months of insulin treatment
• • Not willing to use a NovoPen 6 to record insulin dosing if currently using multiple daily injections
• • Insulin pump, CGM or smart phone devices are not compatible for data transfer
• • Not willing to share device data
• • Current use of any steroidal medication, or planned long-term steroidal treatment (\>4 weeks) during the study period
• • Serum triglycerides \>500 mg/dL
• • History of or plans for bariatric surgery during the study period
• • eGFR \<45 ml/min/1.73 m2
• • 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
• • Planned coronary, carotid, or peripheral artery revascularisation
• • 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
• • Have a pacemaker, or metal implants
• • Participation in other intervention trials during the study period
• • 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