None listed
Conditions
Brief summary
Background: Glucagon-like peptide 1 (GLP-1) receptor agonists are incretin-mimetic agents that are increasingly used in diabetes. The benefits of this class of medications include improvement in glycaemic control, weight loss, modifying cardiovascular risk. Patients with end stage renal disease (ESRD) on dialysis are largely excluded from the seminal large, randomized trials. Cardiovascular disease remains the main cause of mortality and morbidity in patients with ESRD. This study aims to investigate the safety, efficacy and feasibility of investigating GLP-1 agonists in dialysis patients. Aims This pilot study aims to assess the feasibility, safety, tolerability and efficacy of dulaglutide (one type of GLP-receptor agonist) in dialysis patients. Hypothesis It is feasible and safe to use dulaglutide in dialysis patients with diabetes. This will lead to improvement in HbA1c, weight and cardiovascular outcomes.
Interventions
This pilot study aims to assess the feasibility, safety, tolerability and efficacy of dulaglutide (one type of GLP-receptor agonist) in dialysis patients.
All dialysis patients, including both haemodialysis and peritoneal dialysis under the care of Te Whatu Ora Te Toka Tumai Auckland City Hospital will be screened for diabetes with HbA1c of more than 53mmol/mol, or who are already on anti-diabetic therapies. They will be assessed by the investigators if they fulfil the inclusion criteria. They
This pilot study aims to assess the feasibility, safety, tolerability and efficacy of dulaglutide (one type of GLP-receptor agonist) in dialysis patients. All dialysis patients, including both haemodialysis and peritoneal dialysis under the care of Te Whatu Ora Te Toka Tumai Auckland City Hospital will be screened for diabetes with HbA1c of more than 53mmol/mol, or who are already on anti-diabetic therapies. They will be assessed by the investigators if they fulfil the inclusion criteria. They will then be approached by study investigators to see if they are willing to participate in this trial. If they are willing to participate in the study, they will be given dulaglutide in accordance with recommendations from New Zealand Society of Diabetes. For the intervention drug, the dose administered is dulaglutide 1.5mg weekly, with duration of treatment for 12 months. This is a subcutaneous injection. In patients who dialyses in units that can administer subcutaneous medications, this would be administered in the unit when they attend for dialysis. In other patients, they will be asked about adherence during clinic and study visits.
Sponsors
Auckland City Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes. 2. Stable on either haemodialysis, peritoneal dialysis or hybrid therapy (both haemodialysis and peritoneal dialysis) for at least 3 months. 3. Aged 18 years old or older 4. Able to give informed consent. 5. HbA1c >53mmol/mol
Exclusion criteria
Exclusion criteria 1. Known allergy or adverse drug effect to GLP-1 receptor agonists 2. Known severe hepatic dysfunction such as portal hypertension or cirrhosis, acute or chronic hepatitis, signs or symptoms of other liver disease, or an alanine transaminase (ALT) level >3 times the upper limit of normal 3. Have a past history of acute, chronic or idiopathic pancreatitis 4. Excessive alcohol intake above recommended levels 5. Type 1 diabetes 6. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B 7. Malnutrition 8. Pregnancy 9. Planning for coronary, carotid or peripheral artery revascularisation 10. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or had undergone gastric bypass (bariatric) surgery 11. Acute coronary syndrome or cerebrovascular event within 14 days prior to screening 12. In the judgement of the investigator, have any other condition that is likely to limit protocol compliance or reporting of adverse events
Outcome results
None listed