Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies
Authors' conclusion
Individuals with longer-standing T1D and low levels of C-peptide at baseline were more likely to discontinue adjunctive liraglutide treatment due to AEs/lack of tolerance than individuals with residual insulin production. Lower BMI predicted a greater likelihood of non-completion for the included participants, regardless of treatment. These new findings may be relevant for clinical practice.
Study context
- Population
- Participants with T1D receiving liraglutide (1.8, 1.2 or 0.6 mg) or placebo as adjunct to insulin therapy in ADJUNCT ONE and ADJUNCT TWO
- Comparison
- Non-completers vs completers
Methodological detailsphase 3, placebo-controlled
- Phase 3
- Placebo-controlled
Primary result
As reported in the abstract
Baseline characteristics, non-completers vs completers
- Body mass index (BMI), ADJUNCT ONE (non-completers vs completers)
- 27.8 kg/m² vs 29.8 kg/m², P < .0001
- BMI, ADJUNCT TWO (non-completers vs completers)
- 26.3 kg/m² vs 29.2 kg/m², P < .0001
- Duration of T1D, ADJUNCT ONE (non-completers vs completers)
- 25.8 years vs 21.0 years, P < .0001
- Duration of T1D, ADJUNCT TWO (non-completers vs completers)
- 24.1 years vs 21.0 years, P = .04
- Daily insulin dose by CSII, ADJUNCT ONE (non-completers vs completers)
- 46.4 U vs 57.3 U, P = .01
- Daily insulin dose by CSII, ADJUNCT TWO (non-completers vs completers)
- 40.9 U vs 57.4 U, P = .12
- Daily insulin dose by MDI, ADJUNCT ONE (non-completers vs completers)
- 58.4 U vs 68.5 U, P = .006
- Daily insulin dose by MDI, ADJUNCT TWO (non-completers vs completers)
- 56.0 U vs 65.8 U, P =.03
- Undetectable C-peptide, ADJUNCT ONE (non-completers vs completers)
- 91.5% vs 81.3%
- Undetectable C-peptide, ADJUNCT TWO (non-completers vs completers)
- 87.0% vs 84.9%
Further findings
Baseline characteristics by treatment group
- Only duration of T1D and C-peptide differed between completers and non-completers among liraglutide (not placebo) participants
Safety
- Adverse event (AE) rates were higher for non-completers
Original publication
Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. J Diabetes Sci Technol. Published 24 December 2024. doi:10. 1177/ 19322968241305647
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