SURPASS-5
Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes
Dahl D et al. · JAMA
Study record
- Population
475 adults with inadequately controlled type 2 diabetes on glargine, with/without metformin.
Read source · Full-text reportParticipants; Figure 1- Formulation
Single-dose tirzepatide pens versus matching placebo devices.
Read source · Full-text reportInterventions- Route
Subcutaneous.
Read source · Full-text reportInterventions- Dose & frequency
2.5 mg weekly initially; 2.5-mg increases every four weeks toward 5/10/15 mg. Glargine reduced 20% at randomization when HbA1c ≤8%, under trial supervision.
Read source · Full-text reportInterventions- Study design
Double-blind, four-arm randomized add-on comparison.
Read source · Full-text reportRandomization and Blinding- Duration
40 weeks treatment; four-week safety follow-up.
Read source · Full-text reportInterventions- Reported findings
Treatment-regimen HbA1c changes: −2.11/−2.40/−2.34 versus −0.86 percentage points. Efficacy analysis excludes rescue/stopping and gives different estimates.
Read source · Full-text reportPrimary Outcome; Table 2- Adverse events
Serious events: 9/116, 13/119, 9/120 versus 10/120. Severe hypoglycemia: 0, 2, 1 versus 0 participants. Gastrointestinal events common.
Read source · Full-text reportTable 3- Monitoring
Supplementary monitoring includes glucose-guided insulin adjustment and laboratory measures. Hypoglycemia analyses exclude events after new antihyperglycemic therapy began; counts and events per patient-year are different measures.
Read source · Supplementary materialSupplement 2 — eTables 1, 7 and 9; PDF pages 9, 17–18 and 20
What it supports
Add-on glycemic benefit with protocol-managed basal insulin.
What it does not establish
Does not establish unsupervised pairing. Hypoglycemia observation is censored after new antihyperglycemic therapy; events during treatment are not necessarily treatment-caused.
Funding
Eli Lilly and Company; see disclosures.
Literature search cutoff: 2026-09-08 · Not independently clinically reviewed
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