Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): A randomized, open-label, parallel-group, phase 3 trial
The Lancet Aug 18, 2021
Ludvik B, Giorgino FG, Jódar E, et al. - Tirzepatide (5, 10, and 15 mg) was identified as superior to titrated insulin degludec in people with type 2 diabetes inadequately controlled by metformin with or without SGLT2 inhibitors, with greater reductions in HbA1c and bodyweight at week 52 and a lower risk of hypoglycemia. It had a safety profile similar to that of GLP-1 receptor agonists.
This is an open-label, parallel-group, multicenter (122 sites), multinational (13 countries), phase 3 study.
A total of 1,444 patients were randomly assigned to receive treatment with once-weekly subcutaneous injection of tirzepatide (5, 10, or 15 mg) or once-daily subcutaneous injection of titrated insulin degludec.
Initially, tirzepatide was administered at 2·5 mg and escalation of the dose was done by 2·5 mg every 4 weeks until the assigned dose was reached.
Initially, insulin degludec was administered at 10 U per day and its titration was done once weekly to a fasting self-monitored blood glucose of less than 5·0 mmol/L (< 90 mg/dL), following a treat-to-target algorithm, for 52 weeks.
The most common adverse events experienced by tirzepatide-treated participants were mild to moderate gastrointestinal events that reduced over time.
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