Obesity Treatment to Improve Diabetes

Korábbi kezelés

• Have been treated with GLP-1 or SGLT2i within the last 3 months and/or have a history of GLP1RA or SGLT2i intolerance
• Treatment with anti-obesity drugs within 12 weeks prior to randomisation
• Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to randomisation, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)
• Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
• Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.

Más betegség

• Diagnosis of T2D or any other type of diabetes (other than type 1)
• Have terminal illness or are not primarily responsible for their own care
• Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant's ability to participate
• Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
• Personal history of non-familial medullary thyroid carcinoma
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
• History of other severe psychiatric disorders
• History of known or suspected abuse of alcohol and/or narcotics
• History of major depressive episode during the last 2 years
• History of dementia or cognitive impairment

Laborértékek

• eGFR ≤15 mL/min/1.73m2
• Any of the following laboratory values at screening (liver chemistry > 3X upper limit of normal, high Tg (. 5.7 mmol/L)

Egyéb

• Participants will be excluded if:
• Significant changes in the lifestyle (Diet or exercise pattern in within 3 months of the screening visit)
• Any self reported changes (gain or loss) in body weight >5% within 3 months of screening visit
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods during the study period
• Experienced diabetic ketoacidosis within 6 months of screening visit
• Experienced sever hypoglycaemia within 6 months of screening visit
• Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone >6 mIU/litre or <0.4 mIU/litre
• Amylase levels three times higher than the upper normal range
• Initiation of antidepressants during the last 12 weeks

• To be considered eligible to participate in this study, a patient must:
• Be aged between 21-65 years,
• Have a BMI ≥ 25 kg/m2,
• Have established diagnosis of Type 1 Diabetes for at least 1 year before screening visit
• Insulin treatment for T1D - may be either via any FDA approved insulin pump (CSII) for at least 6 months prior to screening visit or via multiple daily insulin injections. All participants must be stable on insulin doses/ regimen for at least 3 months
• Have established diagnosis of Chronic Kidney Disease stage 1-4
• Able to give informed consent