In the phase 3 ADJUNCT ONE and TWO studies, the glucagon-like peptide-1 receptor agonist liraglutide has previously been shown to improve HbA1c, body weight and insulin requirements when used as an adjunct to insulin therapy in people with type 1 diabetes. The present post hoc analysis of these trials sought to determine whether the benefits were consistent across different levels of baseline HbA1c, BMI and insulin regimens.
Data from a total of 2233 participants were analysed. In general, there was a dose–response relationship between liraglutide (0.6 mg, 1.2 mg and 1.8 mg) and outcomes. At 26 weeks, significant reductions in HbA1c (~3.5 mmol/mol), body weight (~5 kg) and daily insulin requirements (~10%) were observed with the highest dose of liraglutide (1.8 mg) compared with placebo in the two trials.
In both trials, the reductions in HbA1c, body weight and insulin dose were found to be independent of baseline HbA1c (< or ≥69 mmol/mol), BMI (< or ≥27 kg/m2) or insulin regimen (multiple daily injections or insulin pump). There were no significant differences in hypoglycaemia rates between the liraglutide and placebo groups. Thus, the authors conclude that the efficacy and safety of liraglutide does not differ according to baseline HbA1c, BMI or insulin regimen in people with type 1 diabetes.
Beta-cell function remains the only clinically relevant parameter to significantly impact the effects of liraglutide, with residual beta-cell function (as measured by C-peptide levels) leading to greater reductions in HbA1c and lower risk of hypoglycaemia.
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