Safety and efficacy of the combination of the glucagon‐like peptide‐1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post‐hoc analysis of a randomized, 52‐week,open‐label,parallel‐group trial |
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| Authors: | Arihiro Kiyosue Yutaka Seino Keiji Nishijima Heidrun Bosch‐Traberg Kohei Kaku |
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| Affiliation: | 1. Department of Internal Medicine, Tokyo‐Eki Center‐Building Clinic, Tokyo, Japan;2. Kansai Electric Power Hospital, Osaka, Japan;3. Clinical Operations Department, Novo Nordisk Pharma Ltd, Tokyo, Japan;4. Novo Nordisk A/S, S?borg, Denmark;5. Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan |
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| Abstract: | Aims/Introduction The aim of the present post‐hoc analysis was to investigate the safety and efficacy of liraglutide in combination with one oral antidiabetic drug (OAD) across different OAD classes. Materials and Methods This was a post‐hoc analysis using data from a 52‐week, open‐label, parallel‐group trial, in which patients with type 2 diabetes inadequately controlled with a single OAD (α‐glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group). The primary outcome investigated in this post‐hoc analysis was the incidence of adverse events. Results The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α‐glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively). Minor hypoglycemia was infrequent (seven episodes in two patients randomized to liraglutide, and two episodes in two patients randomized to additional OAD). The mean reduction in glycated hemoglobin appeared greater with liraglutide therapy, with the estimated mean treatment difference (95% confidence interval [CI]) for liraglutide vs additional OAD ranging from ?0.14%, 95% CI: ?0.48 to 0.21 (?1.5 mmol/mol, 95 CI: ?5.2 to 2.3) to ?0.44%, 95% CI:?0.79 to ?0.09 (?4.8 mmol/mol, 95% CI: ?8.6 to ?1.0). Conclusions The present analysis suggests that Japanese patients on OAD monotherapy might benefit from a greater improvement in glycemic control, without impacting tolerability, by combining their OAD with liraglutide rather than another OAD, regardless of which OAD monotherapy they are receiving. |
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| Keywords: | Glucagon‐like peptide‐1 receptor agonist Liraglutide Type 2 diabetes |
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