Insulin glulisine

Apidra (insulin glulisine) Yes 3-mL pen cartridge or OptiClik pen system... 

Injection 100 units/mL (insulin glulisine [rDNA]) Rx) Apidra (Aventis)... 

INSULIN GLULISINE Give within 15 minutes before a meal or within 20 minutes after starting a meal. Insulin glulisine is intended for subcutaneous administration and for use by external infusion pump. 

Insulin aspart, insulin glulisine - Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient. 

Lactation Lactating women may require adjustments in insulin dose and diet. It is unknown whether insulin glargine, insulin aspart, or insulin glulisine are excreted in significant amounts in breast milk. 

Insulin lispro, insulin aspart, insulin detemir, insulin glargine and insuline glulisine are human in-sullin analogues with the same mechanism of action. It should be noted however that the potency of insulin detemir was decreased four fold compared to human insulin. By changing amino acids on some locations absorption rates and the duration of action may be changed compared to human insulin. 

Disposable insulin pens are also available for selected formulations. These are regular insulin, insulin lispro, insulin aspart, insulin glulisine, insulin glargine, insulin detemir, and several mixtures of NPH with regular, lispro, or aspart insulin (Table 41-4). They have been well accepted by patients because they eliminate the need to carry syringes and bottles of insulin to the workplace and while traveling. 

Insulin glulisine Insulin Separate CV and respiratory No, but the 12-month Standard Recombinant FDA-2004... 

Insulin Glulisine. Summary Basis for Approval, Pharmacology Review, 2004. http // www.fda.gov/cder/foi/nda/2004/21-629 Apidra.htm... 

Pharmacokinetics of HMR1964 (insulin glulisine) syringe-mixed versus simultaneosly injected 0.1 lU/kg HMR1964 (insulin glulisine) and 0.2 lU/kg NPH insulin in healthy subjects using the euglycemic clamp technique. 

To investigate the pharmacokinetics of insulin glulisine following subcutaneous (s.c.) administration of insulin glulisine immediately premixed in a syringe with NPH insulin versus separate simultaneous injections of insulin glulisine and NPH insulin. 

Design, Treatment and Sample Size This was a single-dose, randomized, open-label, two-way, crossover study. 0.1 lU/kg insulin glulisine and 0.2 lU/kg NPH insulin separate and simultaneous s.c. injections in the abdominal area or 0.1 lU/kg insulin glulisine and 0.2 lU/kg NPH insulin by s.c. injection in the abdominal area, immediately after being premixed in the syringe. 

The interpretation of the pharmacokinetic variables Cmax, AUCs and MRT of insulin glulisine was based on 95 % confidence intervals, after ln-transformation of the data. These 95 % confidence intervals were calculated for the respective mean ratios of pair-wise treatment comparisons. In addition, the test treatment was compared to the reference treatment with respect to the pharmacokinetic variables using an ANOVA with subject, treatment and period effects, after ln-transformation of the data. The subject sum of squares was partitioned to give a term for sequence (treatment by period interaction) and a term for subject within sequence (a residual term). Due to the explorative nature of the study, no adjustment of the a-level was made for the multiple testing procedure. 

The time to maximum insulin glulisine concentration (Tmax) was analyzed by non-parametric analyses. 95% non-parametric confidence intervals for the respective median difference in treatment ( test-reference ) were calculated according to the literature. Pair-wise treatment comparison was made for the pharmacokinetic variables. 

HMR1964 (INN insulin glulisine) is a human insulin analogue for the treatment of Type I and Type II patients with diabetes mellitus. Combinations of insulin preparations that differ both in their time of onset and duration of action are used optimally to control blood glucose in patients with diabetes mellitus. The most commonly used insulin regimens include a long-acting in-... 

The insulin glulisine concentration-time profiles are reflected in the following results ... 

Table 15 Pharmacokinetic parameters of HMR1964 (insulin glulisine). Separate simultaneous (Treatment A) versus immediately premixed (Treatment B).

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