Vipidia and Vipdomet: two new products for type II diabetes
Takeda has launched Vipidia and Vipdomet, two new products containing alogliptin for the treatment of type II diabetes.
PHARMACOLOGY
Alogliptin is a dipeptidyl peptidase 4 (DPP4) inhibitor. It is available as a single-component tablet (Vipidia) and as a fixed-dose combination tablet (Vipdomet) which also includes the biguanide oral hypoglycaemic agent, metformin.1,2
By inhibiting DPP4, alogliptin prevents degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This leads to enhanced pancreatic insulin secretion and suppression of glucagon secretion, thereby reducing blood glucose levels.1
CLINICAL STUDIES
The efficacy and safety of alogliptin in combination with metformin were assessed in a 26-week double-blind study in 527 adults inadequately controlled on metformin alone who were randomised to receive metformin (≥1.5g daily) plus either alogliptin or placebo.3
Reduction in HbA1c
Significantly greater decreases in HbA1c from baseline to week 26 were observed in patients receiving alogliptin 25mg once daily compared with those given placebo (p<0.001), with significant reductions evident as early as week 4 (p<0.001 vs placebo). Alogliptin plus metformin was generally well tolerated and its safety profile did not differ greatly from that of placebo plus metformin.3
In another placebo-controlled study involving 500 adults with type II diabetes inadequately controlled on sulfonylurea monotherapy, the addition of alogliptin (25mg daily) to glibenclamide (≥5mg daily) resulted in clinically significant reductions in HbA1c without an increase in the incidence of hypoglycaemia (p≤0.001).4
Long-term efficacy and safety
The long-term efficacy and safety of alogliptin when added to metformin was compared with that of glipizide in the two-year ENDURE study involving 2,639 patients with type II diabetes inadequately controlled by metformin alone. Following a stabilisation period, patients were randomised to receive open-label metformin (≥1.5g daily or maximum tolerated dose) plus alogliptin or glipizide (5mg titrated to a maximum of 20mg daily).5
Non-inferior to glipizide
The mean change in HbA1c from baseline to week 104 was -0.72% in the alogliptin 25mg group compared with -0.59% in the glipizide group, indicating non-inferiority to glipizide. The proportion of patients who achieved HbA1c reductions to ≤7.0% and ≤6.5% at week 104 was significantly higher with alogliptin 25mg than glipizide (p<0.01). Alogliptin was well tolerated throughout the study and similar safety profiles were observed in both treatment groups, with the exception of hypoglycaemia which occurred at a greater rate in the glipizide group.5
Cardiovascular events
The cardiovascular safety profile of alogliptin was evaluated in the EXAMINE study involving 5,380 patients with type II diabetes who had either an acute myocardial infarction or unstable angina requiring hospitalisation within the previous 15 to 90 days. Participants were randomised to receive alogliptin (6.25–25mg once daily according to renal function) orplacebo in addition to standard treatment, with up to 40 months of follow-up (median 18 months).6
Analysis showed that the rates of major cardiovascular adverse events (death from cardiovascular causes, nonfatal MI or non-fatal stroke) were not increased with alogliptin compared with placebo (11.3% vs 11.8%, p<0.001 for non-inferiority).6

武田（Takeda）2013年9月25日宣布，3种2型糖尿病新药：二肽基肽酶IV（DPP-4）抑制剂Vipidia（alogliptin）、固定剂量组合Vipdomet（alogliptin+二甲双胍）、Incresync（alogliptin+吡格列酮）均获得了欧盟委员会（EC）批准，用于现有疗法无法控制其血糖水平的2型糖尿病患者。
这3种新药的获批，是基于一项强有力的临床试验项目的数据。该项目涉及超过11000名患者，治疗时间长达4年，以及2项关键性研究的数据、ENDURE研究的一年数据及EXAMINE实验的中期数据。
该项目，将alogliptin作为饮食和运动的辅助（adjunct）疗法、以及将alogliptin作为其他几类降糖药物（如二甲双胍、吡格列酮、胰岛素、磺脲类药物）的附加（add-on）疗法进行了疗效研究。
这些研究中，每日一次25mg剂量alogliptin表现出了临床和统计学意义的HbA1c水平降低，同时表现出良好的整体耐受性和低血糖发生率。
此外，研究表明，与二甲双胍或吡格列酮单药治疗相比，alogliptin与二甲双胍或吡格列酮联合用药能够显着地改善血糖水平的控制。固定剂量组合药物Vipdomet（alogliptin-二甲双胍）和Incresync（alogliptin-吡格列酮）提供了额外的好处，可能有助于患者减少每日必须服用的药丸数量。
Alogliptin是一种选择性二肽基肽酶IV(DPP-4)抑制剂，该药于2010年4月获得日本卫生劳动福利部（MHLW）批准，目前以商品名Nesina销售。固定剂量组合（alogliptin-pioglitazone）于2011年在日本获批，以商品名Liovel销售。