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Humalog
Clinical Pharmacology
Humalog
In 12-month parallel studies in patients with type 1 and type 2 diabetes, HbA1c 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.
Humalog in Combination with Sulfonylurea Agents
In a two-month study in patients with fasting hyperglycemia despite maximal dosing with sulfonylureas (SU), patients were randomized to one of three treatment regimens; Humulin® NPH at bedtime plus SU, Humalog three times a day before meals plus SU, or Humalog three times a day before meals and Humulin NPH at bedtime. The combination of Humalog and SU resulted in an improvement in HbA1c accompanied by a weight gain (see Table 2).
Table 2 : Results of a Two-Month Study in Which Humalog Was Added to Sulfonylurea Therapy in Patients Not Adequately Controlled on Sulfonylurea Alone
| Humulin N h.s. + SUa |
Humalog a.c. + SU |
Humalog a.c. + Humulin N h.s. |
|
| Randomized (n) | 135 | 139 | 149 |
| HbA1c (%) at baseline | 9.9 | 10.0 | 10.0 |
| HbA1c (%) at 2-months | 8.7 | 8.4 | 8.5 |
| HbA1c (%) change from baseline | -1.2 | -1.6 | -1.4 |
| Weight gain at 2-months (kg) | 0.6 | 1.2 | 1.5 |
| Hypoglycemia* (events/mo) | 0.11 | 0.03 | 0.09 |
| Number of injections | 1 | 3 | 4 |
| Total insulin dose (U/kg) at 2-months | 0.23 | 0.33 | 0.52 |
| a a.c.-three times a day before meals. h.s.-at
bedtime. SU-oral sulfonylurea agent. * blood glucose ≤36mg/dL or needing assistance from third party. |
|||
Humalog in External Insulin Pumps
To evaluate the administration of Humalog via external insulin pumps, two open-label cross-over design studies were performed in patients with type 1 diabetes. One study involved 39 patients treated for 24 weeks with Humalog or regular human insulin. After 12 weeks of treatment, the mean HbA1c values decreased from 7.8% to 7.2% in the Humalog-treated patients and from 7.8% to 7.5% in the regular insulin-treated patients. Another study involved 60 patients treated for 24 weeks with either Humalog or buffered regular human insulin. After 12 weeks of treatment, the mean HbA1c values decreased from 7.7% to 7.4% in the Humalog-treated patients and remained unchanged from 7.7% in the buffered regular insulin-treated patients. Rates of hypoglycemia were comparable between treatment groups in both studies. Humalog administration in insulin pumps has not been studied in patients with type 2 diabetes.
Generic Name: Insulin Lispro (Human Analog)
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