dxy

Liraglutide Added to Glimepiride (LEAD-1)

Liraglutide added to a sulfonylurea was more effective than a sulfonylurea alone or a sulfonylurea combined with rosiglitazone in the randomized, double-blind, 26-week LEAD-1 study. The efficacy and safety of 3 doses of liraglutide (0.6 mg, 1.2 mg, and 1.8 mg) in combination with glimepiride were compared with glimepiride monotherapy and glimepiride + rosiglitazone combination therapy in 1041 patients with type 2 diabetes. All 3 doses of liraglutide administered in combination with glimepiride resulted in superior glycemic control compared with glimepiride monotherapy (P < 0.0001), and the 1.2- and 1.8-mg liraglutide doses resulted in superior glycemic control compared with the combination of glimepiride and rosiglitazone (P < 0.0001) (Table 2). The percentage of patients reaching HbA1c < 7% was significantly higher in the 1.2- and 1.8-mg liraglutide groups compared with the glimepiride monotherapy group (P < 0.0001) and the glimepiride + rosiglitazone group (P ≤ 0.0003). The greatest increase in body weight was seen in the glimepiride + rosiglitazone group, while a decrease was seen in the liraglutide 1.8-mg group (P < 0.0001). β-cell function, assessed by proinsulin-to-insulin ratio and HOMA-β, significantly increased in the liraglutide 1.2-mg and 1.8-mg groups compared with the glimepiride + rosiglitazone group, and significantly increased in the liraglutide 1.2-mg group compared with the glimepiride monotherapy group. Changes in BP did not significantly differ between groups (Table 2). One major hypoglycemic episode occurred in a patient in the 1.8-mg liraglutide group; the episode was thought to be related to glimepiride. The majority of adverse events were gastrointestinal, and most were mild or moderate.