We investigated the use, in a short period, of Humalog Mix25 (Mix25) in a twice-daily administration regimen compared to a twice-daily injection therapy with Humulin 30/70 (30/70) in diabetic patients with Italian dietary habits. We studied 33 type 2 diabetic patients aged 59.1 +/- 8.1 years, BMI 29.8 +/- 2.7 kg/m2, duration of diabetes and insulin therapy of 14.4 +/- 9.8 and 4.2 +/- 4.6 years, respectively. After a 4-day lead-in period of twice-daily human insulin 30/70 treatment, patients were randomized to one of two treatment sequences: (1) a twice-daily regimen with Mix25 just 5 minutes before the morning and evening meals for 12 days, followed by a twice-daily therapy with human insulin 30/70 given 30 minutes before the morning and evening meals for an additional 12 days; or (2) the alternate sequence. Each patient underwent a mixed meal test: Humulin 30/70 was administered 30 minutes before the meal, while Mix25 was given 5 minutes before. The 2-hour post-prandial glucose concentration after breakfast was significantly lower during treatment with Mix25 than with Humulin 30/70 (157 +/- 43.2 vs. 180 +/- 43.2 mg/dl, p<0.05). The glycemic excursion after dinner on Mix25 treatment was significantly lower than with Humulin 30/70 (12.2 +/- 48.01 vs. 35.5 +/- 36.92 mg/dl, p<0.05). AUCglucose after Mix25 was lower than after Humulin 30/70. Glycemia after test meal was significantly lower with Mix25 than with Humulin 30/70. Insulin and free insulin concentrations after the test meal were significantly higher with Mix25 in comparison to Humulin 30/70. AUC serum insulin and free insulin curves after Mix25 were significantly higher than after Humulin 30/70 (p=0.028 and p=0.005, respectively). Twice-daily injections of Humalog Mix25, compared to human insulin 30/70 in type 2 diabetic patients with Italian dietary habits, provide improved and lasting post-prandial glycemic control, with the great convenience of the injection just before the meal.
"Humalog Mix25 (Mix25), a manufactured premixed insulin analogue containing 25% lispro insulin and 75% basal component insulin lispro-protamine, and humalog Mix50 (Mix50) containing 50% lispro and 50% NPL are widely used as a twice-daily insulin regimen.4 Compared to the human insulin mixture, twice-daily injection of Mix25 or Mix50 provided improved glycemic control with a more convenient injection just before a meal.5-7 In addition, twice-daily Mix25 therapy was reported to achieve better glycemic control than basal insulin (glargine) therapy;8 however, it is difficult to make appropriate use of Mix25 and Mix 50 for particular subjects. "
[Show abstract][Hide abstract] ABSTRACT: Premixed insulin is effective to improve glycemic control; however, clinicians may be less likely to know which premixed insulin is appropriate for which patients. This study aimed to evaluate the effects of twice-daily injections of premixed insulin lispro on glycemic control in type 2 diabetic patients.
Forty type 2 diabetic patients, who had been treated with twice-daily injections of human protamine mixture 30/70 insulin for at least 12 months, were divided into two groups; one group whose blood glucose 2 hours after breakfast was greater than 200 mg/dL, was switched to lispro mix50, and the other group whose blood glucose 2 hours after breakfast < 200 was switched to lispro mix25.
Glycated haemoglobin (HbA1c) significantly improved in the Mix50 group from 8.3% to 7.5% (at 12 weeks; p < 0.05), and to 7.5% (at 24 weeks; p < 0.05). On the other hand, HbA1c levels in the Mix25 group were slightly decreased from 8.1% to 7.7% at 12 weeks (p < 0.05), and to 7.9% at 24 weeks (not significant). Both postprandial plasma glucose and fasting plasma glucose levels were significantly improved in the Mix50 group, but not in the Mix25 group. Overall, 95% of subjects preferred premixed lispro insulin from human insulin in the viewpoint of the timing of insulin injection by questionnaire analysis.
Switching from human protamine mixture 30/70 insulin to lispro mix50 twice-daily injection therapy in patients with high postprandial plasma glucose could improve their glycemic control and quality of life.
Yonsei medical journal 11/2010; 51(6):845-9. DOI:10.3349/ymj.2010.51.6.845 · 1.29 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Insulin therapy may eventually be required to maintain glycemic control in many patients with type 2 diabetes mellitus. Premixed insulin analogues offer relatively physiologic and predictable time-action profiles and are available in more convenient delivery systems with finer needles than in the past. They also increase the convenience of administration with respect to mealtimes compared with premixed human insulin, and reduce the number of injections compared with basal-bolus therapy.
This manuscript describes the development of premixed insulin analogues, reviews efficacy and safety data from randomized trials of premixed insulin analogues compared with human insulin 70/30 or basal insulins, and discusses their use for the management of type 2 diabetes.
English-language randomized clinical trials comparing premixed insulin analogues with either premixed human insulin formulations or basal insulins for the treatment of type 2 diabetes, published through May 2005, were identified using PubMed. Pharmacokinetic and pharmacodynamic studies were also included. Abstracts presented at the meetings of the American Diabetes Association, International Diabetes Federation, and the European Association for the Study of Diabetes in 2003 and 2004 were also reviewed.
Premixed insulin analogues allow delivery of both basal and prandial insulin in 1 injection and are more convenient than premixed human insulin formulations. The rapid-acting component is absorbed and cleared more quickly, thereby allowing mealtime administration and providing better postprandial glycemic control. Although there is an increased risk of minor hypoglycemia, 3 comparative, randomized trials have shown that patients using premixed analogues twice daily are more likely to reach glycosylated hemoglobin (HbA(1c)) goals compared with those using only insulin glargine once daily. Premixed insulin analogues are available in vials, pens, and dosers.
Premixed insulin analogues have a more physiologic time-action profile, can be administered closer to mealtime, and produce greater reductions in the magnitude of postprandial glucose excursions than human insulin 70/30. Despite these advantages, no consistent differences in HbA(1c) reduction or the incidence of hypoglycemia versus human insulin 70/30 have been found in most short-term trials. Although there is an increased risk of minor hypoglycemia, patients using premixed insulin analogues twice daily are more likely to reach HbA(1c) goals than those using only insulin glargine once daily. Further studies are necessary to examine whether these advantages improve patient outcomes in clinical practice.
[Show abstract][Hide abstract] ABSTRACT: Premixed insulin analogues, consisting of rapid-acting and intermediate-acting insulin analogues, were developed to more closely mimic physiological endogenous insulin secretion and meet the needs of patients who require both basal and prandial insulin but wish to limit the number of daily injections. There is considerable variability in onset and duration of action, as well as peak insulin levels, obtained with human insulin formulations such as premixed human insulin 70/30. To overcome these limitations, premixed insulin analogues were developed. Peak insulin levels are twice as high and reached in half the time with the rapid-acting insulin component of a premixed insulin analogue. In the US, two premixed insulin analogue formulations are currently available: insulin lispro 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro) and biphasic insulin aspart 70/30 (BIAsp 70/30; 70% insulin aspart protamine suspension and 30% insulin aspart). They are generally administered twice daily, just before breakfast and dinner. Data from various randomised trials show that both insulin lispro 75/25 and BIAsp 70/30 provide more effective postprandial control of blood glucose than premixed human insulin 70/30 or human insulin isophane suspension (NPH insulin). Longer-term glycaemic control, evaluated as changes in glycosylated haemoglobin, is comparable for premixed insulin analogues and premixed human insulin 70/30 in most studies. Three comparative, randomised trials have shown that patients with type 2 diabetes mellitus using premixed insulin analogues twice daily are more likely to reach glycaemic goals than those using only insulin glargine once daily. Some patients can also reach glycaemic goals with once-daily administration of a premixed insulin analogue. Although the incidence of hypoglycaemia is low, direct comparison across trials of premixed insulin analogues is difficult because of inconsistencies in reporting. Within trials, the incidence of both major (rare) and minor hypoglycaemic episodes during treatment with premixed insulin analogues is low and comparable with rates found with human insulin 70/30. Premixed insulin analogues can be safely used, and are effective and convenient for achieving overall glycaemic control in patients with diabetes. In addition, given the convenience of mealtime dose administration, compliance with insulin therapy may increase with premixed insulin analogues.
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