SURPASS-2

Study record

Population

1,879 patients with type 2 diabetes randomized; 1,878 received treatment. Mean baseline HbA1c 8.28%.

Read source · Full-text reportResults — Trial patients, page 506 (primary report archived by USPTO)

Formulation

Tirzepatide single-dose pen versus semaglutide single-patient-use pen. Planned background therapy: stable metformin ≥1,500 mg/day for at least 3 months before screening; continued during treatment, with protocol-defined exceptions.

Read source · Study protocolSections 7.1, 6.1 and 5.1, pages 37, 32 and 29

Route

Subcutaneous injection

Read source · Full-text reportProcedures, page 505 (primary report archived by USPTO)

Dose & frequency

Planned weekly escalation: tirzepatide began at 2.5 mg, increasing by 2.5 mg every 4 weeks to the assigned 5, 10, or 15 mg. Semaglutide began at 0.25 mg for 4 weeks, then 0.5 mg for 4 weeks, then 1 mg. Supervised trial treatment.

Read source · Study protocolSection 7.1, page 37

Study design

Randomized, open-label active-comparator trial. The appendix corrects two erroneous connections in the SAP V2 multiplicity-testing graph and explains the testing sequence. For the treatment-regimen analysis, the 5-mg comparison for achieving HbA1c below 7% was not significant (adjusted p=0.158); this differs from the mean HbA1c-change endpoint.

Read source · Supplementary materialStatistical analyses, printed pages 12–13; Figure S2; Table S2, page 28 (PDF pages 13–14, 16 and 29)

Duration

40-week treatment period, followed by a safety visit approximately 4 weeks after the last treatment visit. Follow-up was without study drug; this is not a repeatable dosing cycle.

Read source · Study protocolSection 5.1, page 28

Reported findings

At 40 weeks, mean HbA1c change: −2.01, −2.24, −2.30 percentage points for tirzepatide 5, 10, 15 mg; semaglutide 1 mg −1.86. Treatment-regimen analysis accounts for discontinuation and rescue medication; inadvertently enrolled patients were excluded from efficacy analyses.

Read source · Full-text reportStatistical analysis and Glycemic end points, pages 505–506 (primary report archived by USPTO)

Adverse events

Mostly mild-to-moderate gastrointestinal events. Serious adverse events: 5–7% with tirzepatide; 3% with semaglutide. Glucose below 54 mg/dL occurred in 0.6%, 0.2%, and 1.7% of the 5-, 10-, and 15-mg tirzepatide groups versus 0.4% with semaglutide. Two severe hypoglycemia events occurred with tirzepatide. These trial rates do not predict individual risk.

Read source · Full-text reportResults — Adverse events and safety; Table 2 (cached publisher text)

Monitoring

Planned monitoring included baseline laboratory tests and ECG, weekly four-point blood-glucose profiles, and seven-point profiles before specified visits. See the full schedule for visit-specific assessments.

Read source · Study protocolSection 5.1, pages 28–29; Section 2 schedule of activities