SURPASS-PEDS

Study record

Population

99 participants aged 10–<18 with type 2 diabetes on metformin and/or basal insulin; weight ≥50 kg, BMI >85th percentile.

Read source · Full-text reportp3 Participants; p5 Figure1

Formulation

Single-dose pens; volume-matched placebo.

Read source · Full-text reportp3 Randomisation and masking

Route

Subcutaneous.

Read source · Full-text reportp3 Randomisation and masking

Dose & frequency

Weekly 2.5 mg initially; +2.5 mg every four weeks to assigned 5 or 10 mg. No dose modification.

Read source · Full-text reportp3 Procedures

Study design

Randomized, double-blind placebo comparison; 32/33/34 participants in 5 mg/10 mg/placebo arms.

Read source · Full-text reportpp3–5 Methods; Figure1

Duration

30 weeks controlled, then 22 weeks open-label; 30-day post-treatment safety follow-up.

Read source · Full-text reportp3 Procedures

Reported findings

Pooled HbA1c difference −2.28 percentage points excluding stopping/rescue data; −1.80 including those events.

Read source · Full-text reportpp4,8 Statistical analysis; Results

Adverse events

At 30 weeks: serious events 1/32, 1/33, 1/34; adverse-event discontinuations 2/32, 0/33, 0/34. Glucose <54 mg/dL: 5/32, 5/33, 2/34; no severe hypoglycemia.

Read source · Full-text reportp10 Table2 — order 5 mg, 10 mg, placebo

Monitoring

Glucose checks three times weekly and with symptoms; baseline HbA1c <8% required a 20% basal-insulin reduction when used. Hypoglycemia counts exclude events after new antihyperglycemic therapy.

Read source · Full-text reportp3 Procedures; p10 Table2 footnote