Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses

Richard E. Pratley, Vanita R. Aroda, Andrei Mircea Catarig, Ildiko Lingvay, Jorg Ludemann, Emre Yildirim, Adie Viljoen

Research output: Contribution to journalArticlepeer-review

Abstract

Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA 1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide. Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5-10, >10 years), HbA 1c (≤7.5, >7.5-8.5, >8.5% (≤58, >58-69, >69 mmol/mol)) and body mass index (BMI) (<30, 30-<35, ≥35 kg/m 2). Setting 194 sites; 16 countries. Participants Subjects with T2D (n=1199) exposed to treatment. Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly. Primary and secondary outcome measures Change in HbA 1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA 1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety. Results HbA 1c and BW reductions (estimated treatment difference ranges: -0.22 to -0.70%-point; -1.76 to -3.84 kg) and proportion of subjects achieving HbA 1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA 1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI. Conclusions Consistently greater improvements in HbA 1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D. Trial registration number NCT02648204.

Original languageEnglish (US)
Article number037883
JournalBMJ Open
Volume10
Issue number11
DOIs
StatePublished - Nov 16 2020

Keywords

  • clinical trials
  • diabetes & endocrinology
  • general diabetes

ASJC Scopus subject areas

  • Medicine(all)

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