SURPASS-2 (tirzepatide 5 mg)
Trial question
What is the role of tirzepatide in patients with T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 939
939 patients (509 female, 430 male).
Inclusion criteria: adult patients with T2DM.
Key exclusion criteria: T1DM; eGFR < 45 mL/min/1.73 m²; history of pancreatitis; history of non-proliferative diabetic retinopathy warranting urgent treatment, proliferative diabetic retinopathy, or diabetic maculopathy.
Interventions
N=470 tirzepatide (initiated at 2.5 mg SC once weekly and increased by 2.5 mg every 4 weeks to a maintenance dose of 5 mg once weekly, continued for a total of 40 weeks).
N=469 semaglutide (initiated at 0.25 mg SC once weekly, titrated every 4 weeks to the maintenance dose of 1 mg once weekly, and continued for a total of 40 weeks).
Primary outcome
Mean reduction in hemoglobin A1C level at week 40
2.01%
1.86%
2.0 %
1.5 %
1.0 %
0.5 %
0.0 %
Tirzepatide
Semaglutide
Significant
increase ▲
NNT = 666
Significantly greater reduction in mean HbA1c level at week 40 (2.01% vs. 1.86%; ARD 0.15, 95% CI 0.03 to 0.28).
Secondary outcomes
Significantly greater reduction in mean body weight at week 40 (7.6 kg vs. 5.7 kg; ARD 1.9, 95% CI 1 to 2.8).
Borderline significantly greater reduction in HbA1c level < 7.0% (82% vs. 79%; AD 3%, 95% CI -0.01 to 6.01).
Significantly greater reduction in HbA1c level < 5.7% (27% vs. 19%; AD 8%, 95% CI 3.25 to 12.75).
Safety outcomes
No significant differences in hypoglycemia, ≥ 1 adverse event.
Conclusion
In adult patients with T2DM, tirzepatide was superior to semaglutide with respect to mean reduction in HbA1c level at week 40.
Reference
Juan P Frías, Melanie J Davies, Julio Rosenstock et al. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515.
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