Semaglutide and body muscle and fat in type 1 diabetes with obesity

Who can take part

• Age 18-65 years old
• Clinical diagnosis of T1D (type 1 diabetes) for ≥ 1 year, as per clinician judgement
• BMI (Body mass index) ≥ 27 kg/m2
• Use of multi-daily injections or insulin pump therapy
• Use of CGM (continuous glucose monitoring)
• Agreement to the use of a highly effective method of birth control in persons of child-bearing age (if sexually active) and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause or have a disclosed medical condition causing sterility (e.g. hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause
• Diabetic retinopathy assessment performed within the last 2 years, as per participant history

Who cannot take part

• Prior hypersensitivity reaction to GLP1-RA (glucagon-like-peptide-1 receptor agonist)
• Any prior diagnostic history of eating disorder or suicidal attempts, or feelings of suicidal thoughts or behaviours in the last month**
• Pre-existing conditions limiting physical activity, specifically inability to walk for 6 minutes
• Active proliferative diabetic retinopathy requiring surgery or laser/injectable therapy within the last 3 months; *If a history of proliferative retinopathy is present within the last year, written permission from the eligible participant's ophthalmologist or optometrist is required*
• History of bariatric surgery
• Personal history of acute/chronic pancreatitis or gallstone disease without cholecystectomy
• Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
• Unstable angina, or myocardial infarction/ cardiovascular surgery / coronary stenting in the last month
• Any serious medical or psychiatric illness likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia)
• HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months
• Severe hypoglycemic episode within the last 3 months, defined as an event where glycemia was < 4 mmol/L, resulting in seizure, loss of consciousness, or need for third-party assistance in treatment
• Severe impairment of renal function with eGFR <30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months
• Current use of non-insulin anti-hyperglycemic agents within the last month
• Diabetic ketoacidosis (DKA) within the last 3 months (DKA refers to the need to present to medical attention and the requirement of intravenous insulin due to ketones)
• Use of supraphysiological doses of glucocorticoids in the last 3 months, and/or expected use at some point in the next 6 months
• Planned or ongoing pregnancy
• Breastfeeding individuals
• Clinically significant gastroparesis, defined as persistent symptoms despite pharmacotherapy such as domperidone