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Pharmacokinetic Profiles of BIOD-123, BIOD-125 and Humalog® |
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Treatment |
Metrics |
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Early 1/2 Tmax (minutes) |
Tmax (minutes) |
Late 1/2 Tmax (minutes) |
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Humalog® |
27.0 +/- 2.7 (25.9) |
65.0 +/- 7.0 (67.5) |
151 +/- 11 (150) |
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BIOD-123 |
9.8 +/- 1.1* (9.6) |
46.4 +/- 14.9 (25.0) |
206 +/- 35 (170) |
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BIOD-125 |
12.4 +/- 2.0* (9.4) |
60.8 +/- 15.2 (30.0) |
179 +/- 41 (140) |
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-- Data represent the Mean +/- SEM; Median Values are presented in parentheses. * p<0.001 vs. Humalog® |
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Injection Site Toleration Profiles of BIOD-123, BIOD-125 and Humalog® |
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Treatment |
Metrics |
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Tolerability (VAS 0 – 100mm) |
Absolute Severity Score |
Relative Severity Score |
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Humalog® |
1.8 +/- 1.1 |
0.17 +/- 0.11 |
2.92 +/- 0.08 |
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BIOD-123 |
3.6 +/- 2.1 |
0.36 +/- 0.15 |
2.91 +/- 0.25 |
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BIOD-125 |
6.8 +/- 2.9* |
0.50 +/- 0.19 |
3.08 +/- 0.26 |
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-- 100 mm Visual Analog Scale: 0=no discomfort, 100=worst possible discomfort -- Absolute Severity Scale: 0=None, 1=Mild, 2=Moderate, 3=Severe -- Relative Severity (compared to usual meal-time injections): 1=Much less, 2=Less, 3=Equal, 4=Increased, 5=Greatly increased * p<0.05 vs. Humalog® |
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