Obesity Treatment to Improve Diabetes (OTID)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes Mellitus, Obesity, Chronic Kidney Disease
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
Participants will be excluded if:
- Have been treated with GLP-1 or SGLT2i within the last 3 months and/or have a history of GLP1RA or SGLT2i intolerance
- Diagnosis of T2D or any other type of diabetes (other than type 1)
- Treatment with anti-obesity drugs within 12 weeks prior to randomisation
- 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
- eGFR ≤15 mL/min/1.73m2
- 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
- Any of the following laboratory values at screening (liver chemistry > 3X upper limit of normal, high Tg (. 5.7 mmol/L)
- 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
- Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone >6 mIU/litre or <0.4 mIU/litre
- 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
- Amylase levels three times higher than the upper normal range
- Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
- 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)
- Initiation of antidepressants during the last 12 weeks
- Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
- 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
- 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.
- History of dementia or cognitive impairment
Sites / Locations
- Dasman Diabetes InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
GLP1RA alone
SGLT2i alone
GLP1RA/SGLT2i combination
GLP1RA/SGLT2i combination with intensive lifestyle changes
Usual Care
Participants in the GLP1RA will be prescribed either Liraglutide 3.0mg or Semaglutide 1.0mg, whichever is licensed and available locally. The dose and titration will follow the usual clinical practice. The treatment will continue for 6 months.
Participants in the SGLT2i group will be prescribed dapagliflozin 5-10mg once daily for 6 months.
Participants in the combination GLP1RA and SGLT2i group will be prescribed liraglutide 3mg once daily or semaglutide1mg once weekly subcutaneous injection plus dapagliflozin 5-10mg for 6 months.
Participants in the combination GLP1RA and SGLT2i and intensive weight loss groupwill be prescribed liraglutide 3mg once daily or semaglutide 1mg once weekly subcutaneous injection plus dapagliflozin 5-10mg together with an intensive dietary and lifestyle approach for 6 months. This typically involves dietary advice to reduce energy intake (and may includea period of partial or total meal replacement), accompanied -if available -by a physical activity programme, both supported by behavioural change techniqueswith regular professional contacts.
Participants in the usual care arm will follow the best medical care by following the international guidelines for 6 months. This usually involves diet and exercise advice.