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继日本中央社会保险医疗委员会批准了Victoza®（利拉鲁肽）的定价之后，诺和诺德制药公司计划将尽快在当地市场推出这种产品。诺和诺德表示，Victoza®是首个在日本获准上市的GLP-1类药物，既可以单独用药，也可以作为辅助药物与磺脲类降糖药(SU)联用。
Liraglutide(利拉鲁肽)安全性、有效性3期临床研究LEAD的6个随机对照研究介绍
Liraglutide Monotherapy Versus Glimepiride (LEAD-3)
The LEAD-3 trial demonstrated the efficacy and safety of liraglutide as monotherapy in 746 patients with type 2 diabetes, 272 (36%) of whom had been previously treated only with diet and exercise. In this randomized, double-blind, 52-week study, treatment with liraglutide 1.2 mg and 1.8 mg resulted in superior glycemic control compared with maximal glimepiride monotherapy. Mean reductions in HbA1c from baseline were 0.51% with glimepiride compared with 0.84% with liraglutide 1.2 mg (P = 0.0014) and 1.14% with liraglutide 1.8 mg (P < 0.0001). The subgroup of patients previously treated with only diet and exercise had a reduction in HbA1c of 1.6% with liraglutide 1.8 mg, 1.19% with liraglutide 1.2 mg, and 0.88% with glimepiride. The percentage of patients reaching the ADA target HbA1c < 7% was also significantly higher in both liraglutide groups. Among patients treated with liraglutide 1.2 and 1.8 mg, 43% and 51%, respectively, reached HbA1c < 7%, while only 28% of glimepiride-treated patients reached this target. Reductions in mean fasting plasma glucose were significantly greater with liraglutide compared with glimepiride (P = 0.027 for liraglutide 1.2 mg and P = 0.001 for liraglutide 1.8 mg). Mean body weight decreased with both liraglutide doses, but increased with glimepiride, resulting in a 3.2- to 3.6-kg mean weight difference between liraglutide and glimepiride. Homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly versus the comparator for both doses of liraglutide (P = 0.0249, P = 0.0011). Systolic BP was significantly reduced with liraglutide 1.8 mg compared with glimepiride (P < 0.0118). Minor hypoglycemia was significantly less frequent in liraglutide-treated patients compared with glimepiride-treated patients (P < 0.0001). No major hypoglycemic episodes were seen during the study. Most adverse events were transient and mild or moderate in severity (Table 2). A slightly higher rate of withdrawal from treatment due to gastrointestinal adverse events was seen in liraglutide-treated patients. An ongoing extension up to 5 years is in progress.
Liraglutide Added to Metformin (LEAD-2)
In the LEAD-2 study, liraglutide added to metformin was shown to be more effective than metformin alone and comparable to metformin plus glimepiride in achieving glycemic control. Additionally, change in body weight significantly differed between the liraglutide groups and the metformin + glimepiride group (P < 0.0001), and weight loss was significantly (P ≤ 0.01) greater in the 1.2- and 1.8-mg liraglutide groups compared with the metformin monotherapy group.
The LEAD-2 trial was a randomized, double-blind, 26-week study involving 1091 patients. The efficacy and safety of 3 doses of liraglutide in combination with metformin were compared with metformin monotherapy and metformin/glimepiride combination therapy. All 3 liraglutide doses (0.6 mg, 1.2 mg, and 1.8 mg) administered in combination with metformin resulted in superior glycemic control compared with metformin monotherapy (P < 0.0001), while the 1.2- and 1.8-mg liraglutide doses produced equal reductions in HbA1c to metformin/glimepiride combination therapy (–1%). The percentage of patients reaching ADA target HbA1c < 7% was significantly (P < 0.02) higher with all 3 liraglutide doses compared with metformin monotherapy, and was similar in the 1.2- and 1.8-mg liraglutide groups compared with the metformin/glimepiride combination therapy group (Table 2). Body weight decreased in the liraglutide groups and the metformin monotherapy group and increased in the metformin ++glimepiride combination therapy group. β-Cell function, as assessed by proinsulin-to-insulin ratio improved significantly versus placebo in all 3 liraglutide groups (P < 0.0001). Systolic BP was reduced in all 3 liraglutide groups and increased in the metformin/glimepiride group (Table 2). Minor hypoglycemia was significantly (P < 0.001) less frequent in the liraglutide groups (~3% in all groups combined) compared with the metformin + glimepiride group (17%). An extension of this trial (up to 2 years) has been completed, but the results have not yet been published.
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