None listed
Conditions
Brief summary
People with type 2 diabetes or pre-diabetes respond differently to medications. This study aims to understand why, and whether certain features of metabolism can help predict which diabetes medicines may work best for different people. In this study we will assess how blood glucose and insulin levels change during treatment with three commonly used diabetes medicines: metformin, tirzepatide and empagliflozin.
Interventions
An open-label, three-treatment randomised crossover trial. Participants receive metformin, empagliflozin (SGLT2 inhibitor) and tirzepatide (GLP-1/GIP receptor agonist) in random order. Each treatment period is 12 weeks, followed by a 6-week washout.
• Metformin: Commenced at 500 mg daily week 1, 500 mg twice daily week 2, 1000 mg morning and 500 mg evening week 3 and 1000 mg twice daily weeks 4-12
• Empagliflozin: 10 mg daily (weeks 1-12)
• Tirzepatide: 2.5 mg weekly (weeks 1-4), 5 mg weekly (w
An open-label, three-treatment randomised crossover trial. Participants receive metformin, empagliflozin (SGLT2 inhibitor) and tirzepatide (GLP-1/GIP receptor agonist) in random order. Each treatment period is 12 weeks, followed by a 6-week washout. • Metformin: Commenced at 500 mg daily week 1, 500 mg twice daily week 2, 1000 mg morning and 500 mg evening week 3 and 1000 mg twice daily weeks 4-12 • Empagliflozin: 10 mg daily (weeks 1-12) • Tirzepatide: 2.5 mg weekly (weeks 1-4), 5 mg weekly (weeks 5-12) Adherence will be monitored through drug return.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• 50-80 years of age • Diagnosed with T2D or pre-diabetes • Managed with diet alone or diet plus metformin
Exclusion criteria
• Chronic liver disease, viral hepatitis, chronic kidney disease (eGFR <30 mL/min/1.73 m²), polycystic ovary syndrome • Relevant medical history or contraindications to study treatment: Personal or family history of medullary thyroid carcinoma, History of pancreatitis, Prior intolerance to metformin, empagliflozin, or tirzepatide • Prior or planned bariatric surgery. • Psychiatric or behavioural problems (e.g., history of drug and alcohol abuse, eating disorder). • Breastfeeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention. • Concurrent participation in any other interventional study.
Outcome results
None listed