Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial
Errata to this article were published (JAMA, 21 Nov 2023 ↗ · 22 Apr 2025 ↗)
Primary result · HbA1c change from baselineResult — go to the resultEstimated treatment difference −0.98 % 95% CI −1.17% to −0.79%Authors' conclusion
In people with inadequately controlled type 2 diabetes treated with basal insulin, weekly tirzepatide compared with prandial insulin as an additional treatment with insulin glargine demonstrated reductions in HbA1c and body weight with less hypoglycemia.
Study context
- Population
- Adults with T2D with inadequate glycemic control on basal insulin; 57.7% women, mean age 58.8 years, mean hemoglobin A1c (HbA1c) 8.8%1,304 completed
- Participants
- 1,428 adults
- Comparison
- Once-weekly tirzepatide vs prandial thrice-daily insulin lispro, both added to insulin glargine
- Tirzepatide 5 mgn = 243
- Tirzepatide 10 mgn = 238
- Tirzepatide 15 mgn = 236
- Insulin lispron = 708reference
- Primary endpoint
- HbA1c change from baseline, tirzepatide (pooled) vs insulin lispro, noninferiority margin 0.3%
- Follow-up
- Week 52
Methodological detailsopen-label, phase 3b, noninferiority, multicentre (135 sites in 15 countries), Enrolled October 19, 2020, to November 1, 2022, Randomized 1:1:1:3
- Open-label
- Phase 3b
- Noninferiority
- Multicentre (135 sites in 15 countries)
- Enrolled October 19, 2020, to November 1, 2022
- Randomized 1:1:1:3
Primary result
HbA1c change from baseline
Estimated treatment difference
−0.98 %
95% CI −1.17% to −0.79%
P < 0.001
Change by group
Tirzepatide (pooled)
−2.1
mean · %
Insulin lispro
−1.1
mean · %
Tirzepatide (pooled)vs Insulin lispro
estimated treatment difference −0.98 % (95% CI −1.17% to −0.79%); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Insulin lispro | Estimated treatment difference (kg) (95% CI) | |
|---|---|---|---|
| Body weight change from baseline · week 52Tirzepatide (pooled)vs Insulin lispro | mean 3.2 kg | −12.2 (−13.4 to −10.9) | |
| −20−10010Difference, kg (linear scale) |
| Outcome | Insulin lispro | OR (95% CI) | |
|---|---|---|---|
| HbA1c <7.0%Tirzepatide (pooled)vs Insulin lispro | 36% | 4.2 (3.2–5.5) | |
| 0.20.5125Odds ratio (log scale) |
- Body weight change from baseline: Tirzepatide (pooled) mean −9.0 kg
- HbA1c <7.0%: Tirzepatide (pooled) 68%
Safety
- Hypoglycemia (<54 mg/dL or severe) — Insulin lispro
- 4.4 events per patient-year
- Hypoglycemia (<54 mg/dL or severe): Tirzepatide (pooled) 0.4 events per patient-year
GI adverse events with tirzepatide (mild to moderate)
- Nausea
- 14%-26%
- Diarrhea
- 11%-15%
- Vomiting
- 5%-13%
Original publication
Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. JAMA. Published 7 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →