20100828埼玉糖尿病先進治療研究会オープニング

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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)
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*
Metformin
n=1393: グリメピリド 最大6 mg 1日1回+ メトフォルミン
1-year interim
analysis
4 weeks
Ferrannini E, et al. Diabetes Obes Metab. 11,2009,, 157
104 weeks
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)
NI: 97.5% CI (0.02,0.16)
Body Weight (kg)
Vilda 50 mg bid + Met
Glim up to 6 mg qd + Met
−1.8 kg
difference
Time (Weeks)
Time (Weeks)
Incidence (%)
n=
Ferrannini E, et al. Diabetes Obes Metab. 11,2009,, 157
Patients with
>1 Hypos (%)
Number of
Hypoglycemic
Events
(Grade 2 and
Suspected Grade 2)
1389 1383
1389 1383
1389 1383
No. of Events
Duration: 52 weeks
Add-on to met:
vilda vs glim
Severe Events
No. of Events
Mean HbA1c (%)
Between-group difference in adjusted mean
change from BL at 52 weeks: 0.09%
Vildagliptin 50 mg twice daily + metformin
Glimepiride up to 6 mg once daily + metformin
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
Odds Ratio
・CCV events: ACS, TIA, Stroke, and CCV death
ビルダグリプチン
n / N (%)
All comparators
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)
M-H RR(95% CI)
0.1
1
10
Vildagliptin better
Vildagliptin worse
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
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)
グルカゴン AUC0-2hr(pmol.hr/L)
5
4
3
2
1
0
ビルダグリプチン
(n=137)
グリメピリド
-1
(n=121)
-2
-3
-4
Baseline glucagon AUC0-2hr:66.6±2.3 pmol.hr/L
-5
*
P<0.001(vs グリメピリド)
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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