SURPASS J-mono

Study record

Population

636 Japanese adults with type 2 diabetes, age at least 20 and BMI at least 23. Oral-medication-naive participants or eligible monotherapy users after an eight-week washout; eligibility HbA1c thresholds differed before washout.

Read source · Supplementary materialEligibility p2; Tables S15-S16

Formulation

Single-use pens for study injections.

Read source · Supplementary materialFigure S1 p26

Route

Once-weekly subcutaneous tirzepatide or dulaglutide.

Read source · Supplementary materialFigure S1 p26

Dose & frequency

Tirzepatide began at 2.5 mg weekly, increasing by 2.5 mg every four weeks to assigned 5, 10 or 15 mg. Comparator dulaglutide was 0.75 mg weekly. This is a reported study schedule, not a personal treatment plan.

Read source · Supplementary materialFigure S1 p26

Study design

Randomized, double-blind phase 3 comparison with dulaglutide 0.75 mg. Primary efficacy analysis excluded observations after rescue or premature discontinuation; a separate treatment-regimen analysis included those observations.

Read source · Supplementary materialAdditional statistical methods p5; Figure S1

Duration

52 weeks of treatment, then four weeks of follow-up. The trial does not establish cycling or restart schedules.

Read source · Supplementary materialFigure S1 p26

Reported findings

Primary efficacy analysis: HbA1c changes of −2.37, −2.55 and −2.82 percentage points versus −1.29 with dulaglutide; weight changes of −5.8, −8.5 and −10.7 kg versus −0.5. Week-52 HbA1c denominators were 142/135/134/138 and weight denominators 143/135/134/138. These are adjusted estimates, distinct from the treatment-regimen analysis.

Read source · Supplementary materialTables S3-S4 pp8-9; S9 p15

Adverse events

Serious adverse events were reported in 8/159, 10/158 and 7/160 tirzepatide participants versus 14/159 with dulaglutide. Individual event categories can overlap. These counts do not by themselves rank overall safety. The corrected appendix retains numerical inconsistencies; complete main-report ascertainment remains unverified.

Read source · Supplementary materialTable S16 pp23-24

Monitoring

The protocol specifies site physician review of ECGs, blood pressure and heart rate, laboratory tests, and anti-tirzepatide antibody sampling. Clinically significant post-dose ECG, vital-sign or laboratory findings resulting in a diagnosis were to be recorded as adverse events. Central cardiologist ECG overreading was optional, not guaranteed. These are planned trial assessments, not a personal monitoring schedule. The separate addendum describes additional assessments at selected sites; these should not be assumed for the entire trial.

Read source · Study protocolSection 9.4.1–9.4.4, printed pp48–50