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
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
| Outcome | Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Insulin glargine | P value |
|---|---|---|---|---|---|
| Change in body weight · Week 104Tirzepatide (all doses) vs Insulin glargine · significantly greater reduction with tirzepatide | −7.6 | −10.0 | −11.4 | 2.1 | P < 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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