SURPASS-6
Trial question
What is the role of tirzepatide in patients with poorly controlled T2DM treated with basal insulin?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 1425
1425 patients (822 female, 603 male).
Inclusion criteria: patients with poorly controlled T2DM treated with basal insulin.
Key exclusion criteria: diagnosis of T1DM; history of pancreatitis; proliferative diabetic retinopathy; diabetic macular edema; non-proliferative diabetic retinopathy requiring immediate treatment; severe hypoglycemia and/or hypoglycemia unawareness.
Interventions
N=717 tirzepatide (initiated at 2.5 mg SC once weekly and increased by 2.5 mg every 4 weeks until the randomly assigned maintenance dose of 5 mg, 10 mg, or 15 mg once weekly was reached, and continued for a total of 52 weeks).
N=708 insulin lispro (prandial dose of 100 IU/mL TID for 52 weeks).
Primary outcome
Reduction in hemoglobin A1C at week 52
2.11%
1.13%
2.1 %
1.6 %
1.1 %
0.5 %
0.0 %
Tirzepatide
Insulin
lispro
Significant
increase ▲
NNT = 102
Significantly greater reduction in HbA1c at week 52 (2.11% vs. 1.13%; AD 0.98%, 95% CI 0.79 to 1.17).
Secondary outcomes
Significant increase in patients achieving HbA1c target < 7.0% at week 52 (68% vs. 36%; OR 4.2, 95% CI 3.2 to 5.5).
Significantly greater reduction in body weight at week 52 (9 kg vs. -3.2 kg; AD 12.2 kg, 95% CI 10.9 to 13.4).
Safety outcomes
No significant differences in ≥ 1 serious adverse event, death.
Significant difference in severe hypoglycemia (0.4% vs. 4.2%).
Conclusion
In patients with poorly controlled T2DM treated with basal insulin, tirzepatide was superior to insulin lispro with respect to reduction in HbA1c at week 52.
Reference
Julio Rosenstock, Juan P Frías, Helena W Rodbard et al. Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. JAMA. 2023 Nov 7;330(17):1631-1640.
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