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

ABSTRACT: 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 Miglyol 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 METHODS: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??g) 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/m2 ; 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 (AEs) 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 AEs 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.

SUBMITTER: Wysham CH 

PROVIDER: S-EPMC5724491 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature