Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes

摘要

Aims To simplify administration of aqueous exenatide once weekly, which requires reconstitution, the exenatide microspheres have been reformulated in a ready‐to‐use autoinjector with a M iglyol diluent (exenatide QWS‐AI ). This study compared the efficacy and safety of exenatide QWS‐AI with the first‐in‐class glucagon‐like peptide‐1 receptor agonist exenatide twice daily ( BID ). Materials and M ethods This randomized, open‐label, controlled study in patients with type 2 diabetes using diet and exercise or taking stable oral glucose‐lowering medication randomized patients 3:2 to either exenatide QWS‐AI (2?mg) or exenatide BID (10?μg) for 28?weeks. The primary outcome was the 28‐week change in glycated haemoglobin ( HbA1c ). A subset of patients completed a standardized meal test for postprandial and pharmacokinetic assessments. Results A total of 375 patients (mean HbA1c , 8.5% [69?mmol/mol]; body mass index, 33.2?kg/m 2 ; diabetes duration, 8.5?years) received either exenatide QWS‐AI (n?=?229) or exenatide BID (n?=?146); HbA1c was reduced by ?1.4% and ?1.0%, respectively (least‐squares mean difference, ?0.37%; P ?=?.0072). More patients achieved HbA1c ?7.0% with exenatide QWS‐AI (49.3%) than with exenatide BID (43.2%; P ?=?.225). Body weight was reduced in both groups ( P ?=?.37 for difference). Gastrointestinal adverse events ( AE s) were reported in 22.7% (exenatide QWS‐AI ) and 35.6% (exenatide BID ) of patients; fewer patients in the exenatide QWS‐AI group withdrew because of AE s than in the exenatide BID group. Minor hypoglycaemia occurred most often with concomitant sulfonylurea use. Conclusions Exenatide QWS‐AI was associated with a greater reduction in HbA1c , similar weight loss and a favorable gastrointestinal AE profile compared with exenatide BID .