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Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials

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  • Thomas Fremming Dejgaard
  • Bernt Johan von Scholten
  • Erik Christiansen
  • Frederik Flindt Kreiner
  • Lars Bardtrum
  • Matthias von Herrath
  • Chantal Mathieu
  • Sten Madsbad
  • ADJUNCT ONE and ADJUNCT TWO Investigators
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AIM: To evaluate 26 weeks of liraglutide treatment in type 1 diabetes (T1D) by subgroups in the ADJUNCT ONE and ADJUNCT TWO trials.

MATERIALS AND METHODS: ADJUNCT ONE and ADJUNCT TWO were randomized controlled phase 3 trials in 1398 and 835 participants with T1D treated with liraglutide (1.8, 1.2, or 0.6 mg) or placebo (adjuncts to insulin). This post hoc analysis evaluated treatment effects by subgroups: HbA1c (< or ≥8.5%), body mass index (BMI; < or ≥27 kg/m2 ), and insulin regimen (basal bolus or continuous subcutaneous insulin infusion).

RESULTS: In both trials at week 26, reductions in HbA1c, body weight, and daily insulin dose did not differ significantly (P > .05) by baseline HbA1c or BMI. Risk of clinically significant hypoglycaemia or hyperglycaemia with ketosis did not differ significantly (P > .05) by baseline HbA1c, BMI, or insulin regimen. At week 26 in ADJUNCT ONE, these risks did not differ (P > .05) between treatment groups. Placebo-adjusted reductions in HbA1c, body weight, and insulin dose (-0.30%-points, -5.0 kg, and -12%, respectively, with liraglutide 1.8 mg), were significant (P < .05), greater than at week 52, and similar to those in ADJUNCT TWO (-0.35%, -4.8 kg, and -10%, respectively, with liraglutide 1.8 mg).

CONCLUSIONS: In ADJUNCT ONE and ADJUNCT TWO, the efficacy and glycaemic safety of liraglutide did not depend on subgroups, leaving residual beta-cell function as the only identified variable impacting the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in T1D. These findings support a role for GLP-1 RAs as adjuncts to insulin in T1D, warranting further study.

Original languageEnglish
Article number14532
JournalDiabetes, Obesity and Metabolism
Volume23
Issue number12
Pages (from-to)2752-2762
Number of pages11
ISSN1462-8902
DOIs
Publication statusPublished - Dec 2021

    Research areas

  • clinical trial, incretin therapy, liraglutide, type 1 diabetes

ID: 67446263