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Head-to-head Study: ビルダグリプチン vs グリメピリド メトフォルミンへの追加投与（ 1 年中間解析）

Head-to-head Study: ビルダグリプチン vs グリメピリド メトフォルミンへの追加投与（ 1 年中間解析）.

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Head-to-head Study: ビルダグリプチン vs グリメピリド メトフォルミンへの追加投与（ 1 年中間解析）

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  1. Head-to-head Study: ビルダグリプチン vs グリメピリドメトフォルミンへの追加投与（1年中間解析） Study purpose: to demonstrate long-term efficacy and safety of add-on therapy with vildagliptin vs glimepiride in patients with T2DM inadequately controlled with ongoing metformin monotherapy in a randomized, double-blind, multicenter study Interim analysis: to demonstrate non-inferiority of vildagliptin vs glimepiride at 1 year Target population: patients with T2DM inadequately controlled on a stable metformin monotherapy (metformin minimum dose 1500 mg/day; baseline HbA1c 6.5–8.5%) n=1396: ビルダグリプチン 50 mg 1日2回+ メトフォルミン N=2789* n=1393: グリメピリド最大6 mg 1日1回+ メトフォルミン Metformin 1-year interim analysis 4 weeks 104 weeks Ferrannini E, et al. Diabetes Obes Metab. 11,2009,, 157

  2. Head-to-head Study: ビルダグリプチン vs グリメピリドメトフォルミンへの追加投与（1年中間解析） Vilda 50 mg bid + Met Vildagliptin 50 mg twice daily + metformin Glim up to 6 mg qd + Met Glimepiride up to 6 mg once daily + metformin Duration: 52 weeksAdd-on to met: vilda vs glim Patients with>1 Hypos (%) Number of Hypoglycemic Events Severe Events (Grade 2 and Suspected Grade 2) n = 1389 1383 1389 1383 1389 1383 Incidence (%) No. of Events No. of Events Between-group difference in adjusted mean change from BL at 52 weeks: 0.09% NI: 97.5% CI (0.02,0.16) Body Weight (kg) −1.8 kgdifference Mean HbA1c (%) Time (Weeks) Time (Weeks) Ferrannini E, et al. Diabetes Obes Metab. 11,2009,, 157

  3. Vildagliptin better Vildagliptin worse ビルダグリプチン　心・脳血管安全性評価メタ解析（PⅢ-25試験 50mg qd N=1393, 50mg bid N=6116） Incidences and Odds Ratios for Adjudicated CCV Events by Treatment 　・CCV events: ACS, TIA, Stroke, and CCV death Odds Ratio 　ﾋﾞﾙﾀﾞｸﾞﾘﾌﾟﾁﾝAll comparators M-H RR(95% CI) n / N (%) n / N (%) Vilda 50 mg qd 10/1393 (0.72) 14/1555 (0.90) 0.88 (0.37 - 2.11) Vilda 50 mg bid 81/6116 (1.32) 80/4872 (1.64) 0.84 (0.62 - 1.14) 0.1 1 10 Data were pooled from 25 Phase III studies of vildagliptin, used either as monotherapy or combination therapy, with durations of 12 weeks to ≥2 years. The safety of vildagliptin [50 mg qd (N = 1393) or 50 mg bid (N = 6116)] was assessed relative to a pool of all comparators [both placebo and active comparators (N = 6061)]. Diabetes, Obesity and Metabolism 2010 12: 485

  4. ビルダグリプチンとグリメピリドの グルカゴンへの影響（2年間の検討） 5 4 3 2 ビルダグリプチン (n=137) 1 0 グリメピリド (n=121) グルカゴン AUC0-2hr(pmol.hr/L) -1 -2 -3 Baseline glucagon AUC0-2hr：66.6±2.3 pmol.hr/L -4 * -5 P<0.001（vs ｸﾞﾘﾒﾋﾟﾘﾄﾞ） メトホルミンでコントロール不十分な2型糖尿病患者を対象に、グルカゴンへの影響をグリメピリドとビルダグリプチン50mg1日2回とで比較検討した。 Ahren B, et al. Diabetes Care 33:730–732, 2010

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