Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial

摘要: Summary Background Most patients with type 2 diabetes begin pharmacotherapy metformin, but eventually need additional treatment. We assessed the safety and efficacy of once weekly exenatide, a glucagon-like peptide 1 receptor agonist, versus maximum approved doses dipeptidyl peptidase-4 inhibitor, sitagliptin, or thiazolidinedione, pioglitazone, in treated metformin. Methods In this 26-week randomised, double-blind, double-dummy, superiority trial, who had been at baseline mean glycosylated haemoglobin (HbA 1c ) 8·5% (SD 1·1), fasting plasma glucose 9·1 mmol/L (2·6), weight 88·0 kg (20·1), were enrolled 72 sites USA, India, Mexico. Patients randomly assigned to receive: mg injected exenatide plus oral placebo daily; 100 sitagliptin daily weekly; 45 pioglitazone weekly. Primary endpoint was change HbA between week 26. Analysis by intention treat, for all received least one dose study drug. This trial is registered ClinicalTrials.gov, number NCT00637273. Findings 170 receive 172 pioglitazone. 491 drug included intention-to-treat analysis (160 on 166 165 pioglitazone). Treatment reduced (least square −1·5%, 95% CI −1·7 −1·4) significantly more than did (−0·9%, −1·1 −0·7) (−1·2%, −1·4 −1·0). differences −0·6% (95% −0·9 −0·4, p Interpretation The goal many clinicians manage achieve optimum control alongside loss minimum hypoglycaemic episodes. Addition metformin achieved often addition either Funding Amylin Pharmaceuticals Eli Lilly.