SURPASS-CN-MONO

Study record

Population

Adults with type 2 diabetes, HbA1c 7.0–9.5%, BMI ≥23 and stable weight. No antihyperglycemic medication in the preceding 90 days, with a specified short-term insulin exception. Participants agreed not to start a separate weight-reduction program.

Read source · Study protocolProtocol section 5.1, printed page 28

Formulation

Single-dose injection pens containing tirzepatide or matched placebo. Compounded preparations were not evaluated.

Read source · Study protocolProtocol section 6.1.1, printed page 33

Route

Once-weekly subcutaneous injection.

Read source · Study protocolProtocol section 6.1.1, printed page 33

Dose & frequency

Assigned maintenance doses were 5, 10 or 15 mg weekly. The protocol began at 2.5 mg weekly for four weeks, increasing by 2.5 mg every four weeks to the assigned dose. These are trial procedures, not a personal dosing cycle.

Read source · Study protocolProtocol section 6.1.1, printed page 33

Study design

Randomized placebo comparison. The SAP distinguishes a treatment-regimen ANCOVA analysis, including rescue or treatment interruption, from an efficacy MMRM analysis. Planned multiple imputation for the former uses retrieved dropouts with a placebo-reference fallback; the SAP does not prove which fallback was implemented.

Read source · Study protocolSAP sections 4.8.2–4.8.3, printed pages 18–19

Duration

40 weeks of treatment; registry adverse-event observation extends through week 44.

Read source · Registry resultsRegistry arm descriptions and adverse-event timeframe

Reported findings

Registry week-40 HbA1c changes were −2.19/−1.75/−2.03/−0.77 percentage points for 5/10/15 mg/placebo, with posted denominators 52/44/48/47. This ANCOVA analysis includes data irrespective of adherence or rescue; it must not be merged with the publication’s efficacy-estimand results.

Read source · Registry resultsPrimary outcome — analysis, population, denominators and estimates

Adverse events

Through week 44, serious events affected 5/52, 6/51, 3/52 and 5/51 in the 5/10/15 mg/placebo groups; deaths were zero. Nonserious diarrhea affected 12/52, 12/51, 15/52 and 0/51. The nonserious table has a 5% reporting threshold. Counts are all-cause observations, not proof of treatment causation. Full publication safety reconciliation remains incomplete.

Inspect extraction gap · Registry resultsRegistry adverse events — systematic assessment, timeframe, threshold and participant counts

Monitoring

Protocol procedures included fasting glucose four times weekly and two seven-point glucose profiles before randomization, week 24 and week 40. Participants recorded glucose and hypoglycemia in diaries and checked glucose when symptoms were suspected. Baseline laboratories and ECG preceded the first injection in clinic.

Read source · Study protocolProtocol section 4.1, printed pages 24–25