How to start patients on Humalog and Humalog Mixture insulins.
Humalog Mix75/25 Helps Provide Improved Control
Two open-label, randomized, crossover trials compared the glycemic response to Humalog Mix75/25 BID + metformin with that of glargine QD + metformin.
- PAIR-IN: Insulin-naive patients with type 2 diabetes1
- 105 patients; 67 patients included in efficacy analysis (29 patients excluded, since they may have received expired study drug)
- Baseline A1C: 8.7%
- PAIR-PI: Inadequately controlled patients with type 2 diabetes on once- or twice-daily insulin alone or in combination with oral agents2
- 97 patients
Confirmatory evidence: real-world results
A retrospective observational analysis involved the review of a national medical records database with 112,862 patients with type 2 diabetes.3
- Patients selected for analysis had multiple A1C records and used Humalog Mix75/25 or glargine with or without oral agents between 1998 and 20043
- Primary measures were baseline A1C values and the mean A1C values in 1 of 4 post-baseline quarters3
Note: PAIR-IN average daily dose of insulin 0.62 (0.37) U/kg for Humalog Mix75/25 vs 0.57 (0.37) U/kg glargine (P<.001). PAIR-PI average daily dose of insulin 0.42 (0.20) U/kg for Humalog Mix75/25 vs 0.36 (0.18) U/kg glargine (P<.001).
Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not demonstrate a difference in the overall rate of hypoglycemia between the two treatments. The clinical significance of improvement in postmeal hyperglycemia has not been established.
For important safety information and other prescribing considerations, please see Humalog Mix75/25 Prescribing Information.
References:
1. Malone JK, Kerr LF, Campaigne BN, et al. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther. 2004;26(12):2034-2044.
2. Malone JK, Bai S, Campaigne BN, et al. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycemic control in patients with Type 2 diabetes. Diabet Med. 2005;22(4):374-381.
3. Sun P, Wang R, Jacober SJ. Therapeutic effectiveness of insulin initiation regimens among patients with type 2 diabetes: once-daily basal insulin or twice-daily premixed insulin? Poster presented at 2006 Annual Conference of American Diabetes Association; June 9-13, 2006; Washington, DC. Abstract No. 427-P.
1. Malone JK, Kerr LF, Campaigne BN, et al. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther. 2004;26(12):2034-2044.
2. Malone JK, Bai S, Campaigne BN, et al. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycemic control in patients with Type 2 diabetes. Diabet Med. 2005;22(4):374-381.
3. Sun P, Wang R, Jacober SJ. Therapeutic effectiveness of insulin initiation regimens among patients with type 2 diabetes: once-daily basal insulin or twice-daily premixed insulin? Poster presented at 2006 Annual Conference of American Diabetes Association; June 9-13, 2006; Washington, DC. Abstract No. 427-P.
Important Safety Information
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing mothers.
Potential side effects associated with the use of all insulins include hypoglycemia, weight gain, hypokalemia, lipodystrophy, and hypersensitivity. Because of the difference in action of Humalog, care should be taken in patients in whom these conditions may be clinically relevant (e.g., those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level). Patients should be advised not to mix Humalog Mix75/25 or Humalog Mix50/50 with another insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.
When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Humalog Mix75/25 and Humalog Mix50/50 are not indicated for use in external insulin pumps.
Humalog differs from regular human insulin by its rapid onset of action, as well as a shorter duration of activity. Therefore, Humalog and Humalog Mixtures should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. The short duration of action of Humalog means that patients such as those with type 1 diabetes, whose basal insulin levels are inadequate, will also require a longer-acting insulin to give optimal glucose control (except when using an insulin pump).
Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not show a difference in the overall rate of hypoglycemia between the two treatments. The overall rate of hypoglycemia did not differ between type 1 and type 2 patients treated with Humalog, as compared with regular human insulin. The lower rate of hypoglycemia with Humalog may be related to higher nocturnal blood glucose levels, as reflected by a small increase in the mean fasting blood glucose levels.
The clinical significance of improvement in postmeal hyperglycemia has not been established. In 12-month clinical studies, A1C did not differ between patients treated with regular human insulin and those treated with Humalog.
Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.
For other important safety information and prescribing considerations, please see Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.
Humalog is a registered trademark of Eli Lilly and Company. Humalog Mix75/25 and Humalog Mix50/50 are trademarks of Eli Lilly and Company.
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing mothers.
Potential side effects associated with the use of all insulins include hypoglycemia, weight gain, hypokalemia, lipodystrophy, and hypersensitivity. Because of the difference in action of Humalog, care should be taken in patients in whom these conditions may be clinically relevant (e.g., those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level). Patients should be advised not to mix Humalog Mix75/25 or Humalog Mix50/50 with another insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.
When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Humalog Mix75/25 and Humalog Mix50/50 are not indicated for use in external insulin pumps.
Humalog differs from regular human insulin by its rapid onset of action, as well as a shorter duration of activity. Therefore, Humalog and Humalog Mixtures should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. The short duration of action of Humalog means that patients such as those with type 1 diabetes, whose basal insulin levels are inadequate, will also require a longer-acting insulin to give optimal glucose control (except when using an insulin pump).
Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not show a difference in the overall rate of hypoglycemia between the two treatments. The overall rate of hypoglycemia did not differ between type 1 and type 2 patients treated with Humalog, as compared with regular human insulin. The lower rate of hypoglycemia with Humalog may be related to higher nocturnal blood glucose levels, as reflected by a small increase in the mean fasting blood glucose levels.
The clinical significance of improvement in postmeal hyperglycemia has not been established. In 12-month clinical studies, A1C did not differ between patients treated with regular human insulin and those treated with Humalog.
Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.
For other important safety information and prescribing considerations, please see Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.
Humalog is a registered trademark of Eli Lilly and Company. Humalog Mix75/25 and Humalog Mix50/50 are trademarks of Eli Lilly and Company.
