Type 2 & other diabetes

Long‐term efficacy and safety of tirzepatide in participants with type 2 diabetes with inadequate glycaemic control on metformin and/or sulfonylurea: Post‐hoc analysis of SURPASS ‐4

Diabetes Obes MetabPublished Post-hoc analysis of the SURPASS-4 randomised trial

Authors' conclusion

Tirzepatide significantly improved glycaemic control and body weight reduction compared to insulin glargine over 104 weeks in participants with type 2 diabetes inadequately controlled on metformin and/or sulfonylurea. The safety profile of tirzepatide was acceptable, with a lower incidence of hypoglycaemia than insulin glargine.

Study context

Population
Participants with T2D with inadequate glycaemic control on metformin and/or SU
Participants
1,500 participants
Comparison
Tirzepatide vs insulin glargine
Primary endpoint
Change in HbA1c from baseline
Follow-up
104 weeks
Methodological detailsmulticentre, phase III
  • Multicentre
  • Phase III

Primary result

As reported in the abstract

Mean change in HbA1c · Week 104

Tirzepatide 5 mg

−2.3

mean · %

Tirzepatide 10 mg

−2.5

mean · %

Tirzepatide 15 mg

−2.6

mean · %

Insulin glargine

−1.0

mean · %

P < 0.001

Secondary outcomes

kg

OutcomeTirzepatide 5 mgTirzepatide 10 mgTirzepatide 15 mgInsulin glargineP value
Change in body weight · Week 104Tirzepatide (all doses) vs Insulin glargine · significantly greater reduction with tirzepatide−7.6−10.0−11.42.1P < 0.001
HbA1c <7.0% · Week 104 · Tirzepatide vs Insulin glargine · significantly more participants with tirzepatide
P < 0.001

Safety

Incidence of hypoglycaemia was lower with tirzepatide
Gastrointestinal adverse events (AEs) were mild or moderate in severity

Original publication

Long‐term efficacy and safety of tirzepatide in participants with type 2 diabetes with inadequate glycaemic control on metformin and/or sulfonylurea: Post‐hoc analysis of SURPASS ‐4. Diabetes Obes Metab. Published 9 September 2025. doi:10.1111/dom.70047

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