Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial
Authors' conclusion
Tirzepatide added to basal insulin improved glycaemic control and was generally well tolerated, providing evidence to support its potential therapeutic use in patients with type 2 diabetes in China.
Study context
- Population
- Adults aged ≥18 years with uncontrolled T2D on once-daily insulin glargine alone or with metformin ± SGLT2i, 26 hospitals in China255 in efficacy analysis
- Participants
- 257 adults
- Comparison
- Once-weekly tirzepatide 5 mg, 10 mg or 15 mg vs placebo, added to basal insulin
- Tirzepatide 5 mgn = 65
- Tirzepatide 10 mgn = 65
- Tirzepatide 15 mgn = 63
- Placebon = 64reference
- Primary endpoint
- Change in HbA1c from baseline for tirzepatide 10 mg or 15 mg vs placebo
- Follow-up
- Week 40
Methodological detailsdouble-blind, multicentre, placebo-controlled, phase 3, 40-week, stratified by HbA1c and SGLT2i use
- Double-blind
- Multicentre
- Placebo-controlled
- Phase 3
- 40-week
- Stratified by HbA1c and SGLT2i use
Primary result
As reported in the abstract
Change in HbA1c from baseline
Tirzepatide 10 mg
−2.39
SE 0.13 · %
Tirzepatide 15 mg
−2.37
SE 0.13 · %
Placebo
−0.91
SE 0.12 · %
Each group vs placeboDifference, % (97.5% CI)P value
Tirzepatide 10 mg
−1.48(−1.87 to −1.08)
P < 0.0001Tirzepatide 15 mg
−1.45(−1.85 to −1.06)
P < 0.0001Safety
| Outcome | Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Placebo |
|---|---|---|---|---|
| Diarrhoea (TEAE) | 26% (95% CI 17–38) | 37% (95% CI 26–49) | 37% (95% CI 26–49) | 8% (95% CI 3–17) |
| Decreased appetite (TEAE) | 29% (95% CI 20–41) | 25% (95% CI 16–36) | 32% (95% CI 22–44) | 0% (95% CI 0–6) |
| Upper respiratory tract infection (TEAE) | 20% (95% CI 12–31) | 17% (95% CI 10–28) | 18% (95% CI 10–29) | 16% (95% CI 9–26) |
| Nausea | 5% (95% CI 2–13) | 11% (95% CI 5–21) | 11% (95% CI 5–21) | 3% (95% CI 1–11) |
| VomitingGI AEs predominantly mild or moderate in severity | 6% (95% CI 2–15) | 9% (95% CI 4–19) | 6% (95% CI 3–15) | 0% (95% CI 0–6) |
Original publication
Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. Published 27 October 2025. doi:10.
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