Humalog

[Insulin Lispro]

Figure 3 Blood glucose levels after subcutaneous injection of human regular insulin or Humalog (0.2 U/ kg) immediately before a high carbohydrate meal in 10 patients with type 1 diabetes.*

*Baseline insulin concentration was maintained by infusion of 0. 2 mU/ min/ kg human insulin.
In open-label, crossover studies of 1008 patients with type 1 diabetes and 722 patients with type 2 (non-insulin-dependent) diabetes, Humalog reduced postprandial glucose compared with human regular insulin (see Table 1). The clinical significance of improvement in postprandial hyperglycemia has not been established.

Time, minutes
0 60 120 180 240 300 360 420 480

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Blood
Glucose,

mg/ dL

0
50
100
150

200
250
Humalog (n= 10) Humulin R (n= 10)

(Mean dose: 15. 4 U)

Table 1 Comparison of Means of Glycemic Parameters at the End of Combined Treatment Periods. All Randomized Patients in Cross-over Studies (3 months for each treatment) Type 1, N= 1008
Glycemic Parameter, (mg/ dL) Humalog a Humulin R a * Fasting Blood Glucose
1-Hour Postprandial 2-Hour Postprandial HbA1c (%)

209.5 ± 91.6 232.4 ± 97.7
200.9 ± 95.4 8.2 ± 1.5
204.1 ± 89.3 250.0 ± 96.7
231.7 ± 103.9 8.2 ± 1.5
Type 2, N= 722 Glycemic Parameter, (mg/ dL) Humalog a Humulin R a
Fasting Blood Glucose 1-Hour Postprandial
2-Hour Postprandial HbA1c (%)
192.1 ± 67.9 238.1 ± 79.7
217.4 ± 83.2 8.2 ± 1.3
183.1 ± 66.1 250.0 ± 75.2
236.5 ± 80.6 8.2 ± 1.4
a Mean ± Standard Deviation
* Humulin R (human insulin [rDNA origin] injection)

In 12-month parallel studies in patients with type 1 and type 2 diabetes, HbA 1c did not differ between patients treated with human regular insulin and those treated with Humalog.

Hypoglycemia--

While the overall rate of hypoglycemia did not differ between patients with type 1 and type 2 diabetes treated with Humalog compared with human regular insulin, patients with type 1 diabetes treated with Humalog had fewer hypoglycemic episodes between midnight and 6 a. m. The lower rate of hypoglycemia in the Humalog-treated group may have been related to higher nocturnal blood glucose levels, as reflected by a small increase in mean fasting blood glucose levels.

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