SUMMARY
HUMALOG® Mix50/50TM
50% INSULIN LISPRO PROTAMINE SUSPENSION AND
50% INSULIN LISPRO INJECTION
(rDNA ORIGIN)
UNITS PER ML (U-100)
Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid–acting blood glucose–lowering agent and insulin lispro protamine suspension, an intermediate–acting blood glucose–lowering agent.
Humalog Mix50/50, a mixture of 50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Based on cross–study comparisons of the pharmacodynamics of Humalog Mix50/50 and Humulin 50/50, it is likely that Humalog Mix50/50 has a more rapid onset of glucose–lowering activity compared with Humulin 50/50 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.
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NEWS HIGHLIGHTS
Published Studies Related to Humalog Mix50 / 50 (Insulin Lispro Subcutaneous)
Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study. [2009.07]
CONCLUSIONS: In unselected people with type 1 diabetes naive to CSII or insulin glargine, glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy.
Effect of a local heating device on insulin and glucose pharmacokinetic profiles in an open-label, randomized, two-period, one-way crossover study in patients with type 1 diabetes using continuous subcutaneous insulin infusion. [2009.05]
BACKGROUND: Reducing postprandial hyperglycemia and hypoglycemia is a major challenge in the treatment of patients with diabetes. Studies suggest that heating the insulin injection site may accelerate insulin absorption. InsuPatch (InsuLine Medical Ltd., Petach-Tikva, Israel) is a device intended to accelerate subcutaneous insulin delivery using an insulin pump by locally warming the infusion site. OBJECTIVE: The aim of this study was to assess the effect of the InsuPatch device on the pharmacokinetics of short-acting insulin analogues and on postprandial glycemia... CONCLUSION: In this pilot study, use of the InsuPatch was associated with significant decreases in T(max) and T(50%max) and increases in insulin AUC and C(max) of subcutaneous infused rapid-acting insulin analogues, resulting in a lower postprandial glucose excursion in these patients with type 1 diabetes mellitus treated with CSII.
Better postprandial glucose stability during continuous subcutaneous infusion with insulin aspart compared with insulin lispro in patients with type 1 diabetes. [2008.12]
BACKGROUND: Persistent glucose variability is a frequent condition in type 1 diabetes. Continuous subcutaneous insulin infusion (CSII) is a rational option to overcome this clinical issue; however, no comparative studies have been reported for aspart and lispro insulin when used in CSII. This study compare the effects of aspart and lispro delivered by CSII on glycemic stability as measured using a continuous glucose monitoring system... CONCLUSIONS: Postprandial glucose was more stable when insulin aspart was infused as a pre-meal bolus compared with insulin lispro, indicating a more favorable effect of insulin aspart on postprandial glucose. No differences in overall daily glucose stability were observed between insulin aspart and insulin lispro when infused as basal rate insulin.
AIR inhaled insulin versus subcutaneous insulin: pharmacokinetics, glucodynamics, and pulmonary function in asthma. [2008.04]
CONCLUSIONS: This study suggests that pulmonary disease severity and asthma treatment status influence the metabolic effect of AIR insulin in individuals with asthma but do not affect AIR insulin pulmonary safety or tolerability. In view of the potential interactions between diabetes treatment and pulmonary status, it is prudent to await the results of ongoing clinical trials in diabetic patients with comorbid lung disease before considering the use of inhaled insulin in such patients.
Effects of smoking cessation, acute re-exposure and nicotine replacement in smokers on AIR inhaled insulin pharmacokinetics and glucodynamics. [2008.04]
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: * Only one other study (Becker et al.) has reported on the influence of smoking cessation and smoking resumption on inhaled insulin pharmacokinetics and glucodynamics, concluding that the rapid changes associated with smoking resumption carry the risk for hypoglycaemia and thus should not be used by active smokers. WHAT THIS STUDY ADDS: * This is the first euglycaemic clamp study on the impact of smoking cessation, acute smoking re-exposure and nicotine replacement on AIR((R)) inhaled insulin pharmacokinetics and glucodynamics. * We demonstrate clinically and statistically significant shifts in glucodynamic response to acute re-exposure to a single cigarette, leading us to conclude that active smokers should be advised against inhaled insulin therapy until smoking abstinence is stable. * Additionally, these results are also the first to demonstrate an apparent independent effect of nicotine replacement therapy on insulin exposure and glucodynamic response. AIMS: To explore the effects of smoking cessation and acute smoking re-exposure on the pharmacokinetic (PK) and glucodynamic (GD) profiles of AIR inhaled insulin (AIR Insulin) with or without nicotine replacement therapy (NRT)... CONCLUSION: Smoking, smoking cessation and acute re-exposure with a single cigarette are associated with clinically significant alterations in AIR Insulin pharmacokinetics and glucodynamics. AIR Insulin should not be used by smokers or those at risk for recidivism.
Clinical Trials Related to Humalog Mix50 / 50 (Insulin Lispro Subcutaneous)
A Clinical Trial Comparing Efficacy and Safety of Exubera and Humalog [Recruiting]
To compare efficacy and safety of Exubera vs Humalog in patients with type 1 diabetes
mellitus
Local Registration Trial in China Humalog Mix 50 [Completed]
The primary objective of this study is to compare the 2-hour PPBG excursion following a
standard test meal in insulin-requiring diabetic patients treated twice daily with human
insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with
insulin lispro mix 50/50.
Lyspro Insulin vs Regular Insulin in Cirrhotic Patients [Completed]
OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients
with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver
cirrhosis and type 2 diabetes were randomly treated with regular insulin or lispro. After
122 weeks a cross-over was carried out and patients followed-up for 122 weeks. Then, all
patients received a standard breakfast of 145 kcal following 12 U. I. of regular insulin or
lispro, and C-peptide and insulin serum levels were determined over 300 minutes.
Comparison of Insulins Aspart and Lispro in Insulin Pumps [Active, not recruiting]
The purpose of the study is to study compare the glycemic control between insulins aspart and
lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes
using an insulin pump.
Phase II PK Study With Humalog and Humulin R With and Without rHuPH20 in T1DM [Recruiting]
Humalog and Humulin R are FDA approved medications for the treatment of diabetes mellitus.
Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption
and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with
both Humalog and Humulin R in order to determine if it improves the absorption of these
insulins to more closely mimic the body's natural increase in insulin in response to a meal.
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