HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® a drug based on insulin lispro + insulin lispro protamine

THERAPEUTIC GROUP: Biphasic insulin for injectable use - insulins and analogues

Indications HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® is indicated in the treatment of diabetes mellitus which requires insulin therapy to ensure good glycemic control.

Mechanism of action HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® is a drug based on insulin analogues with different timing of action, and consisting of insulin lispro and insulin lispro protamine.
These two different forms of insulin respectively allow a rapid action intervention, therefore useful for the control of postprandial hyperglycemia, and an intermediate one, necessary for the prolonged maintenance of the hypoglycemic action.
In principle, therefore, insulin lispro is rapidly absorbed reaching maximum plasma concentrations within about 50 minutes, although the onset of its biological effect is decidedly anticipated 15 minutes after its intake, while insulin lispro protamine can maintain the own therapeutic effect even for 18 hours.
It is evident that although the two different insulin forms have very different absorption profiles and action times, the molecular mechanism of action remains the same for both, acting on the sensitive insulin tissues allowing a better uptake and utilization of blood glucose.

Studies carried out and clinical efficacy

1. BIPHASIC INSULIN AND INFLAMMATORY MARKERS

Diabet Med. 2011 Apr 25.

Meal-induced increases in C-reactive protein, interleukin-6 and tumor necrosis factor α are attenuated by prandial + basal insulin in patients with Type 2 diabetes.

Beisswenger PJ, Brown WV, Ceriello A, Le NA, Goldberg RB, Cooke JP, Robbins DC, Sarwat S, Yuan H, Jones CA, Tan MH; for the IOOI Study Investigators.

The administration of biphasic insulin in second type diabetic patients for 24 weeks has been shown to be particularly useful in reducing some inflammatory markers such as C reactive protein, interleukin 6 and TNF alpha in the immediate postprandial period, evidently allowing a better metabolic control.

2. BIPHASIC INSULIN AND TYPE SECOND DIABETIC PATIENTS

Diabetes Care. 2011 Feb; 34: 249-55.

The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine.

Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL.

The administration of insulin lispro / insulin lispro protamine, according to the percentages present in HUMALOG MIX, in diabetic patients of the second type ensured better glycemic control with a longer duration of action of the drug, compared to the combined insulin glargine - oral hypoglycemic therapy. These effects were most significant in the diabetic patient with good starting glycemic control.

3. BIPHASIC THERAPY AND WEIGHT INCREASE

J Diabetes. 2010 Dec; 2: 250-5. doi: 10.1111 / j.1753-0407.2010.00080.x.

Evaluation of the weight-increasing effects of biphasic analog and regular NPH insulin mixtures in patients with Type 2 diabetes mellitus.

Temizel M, Mert M, Bozbey C, Arman Y, Cevizci E, Altintaş N, Cetin Ölek A.

Unfortunately, biphasic insulin therapy has not shown particular advantages in the management of the body weight of the diabetic patient compared to classic insulin therapies. This remains an important issue to be carefully considered as it is detrimental to the patient's physical and psychological health.

Method of use and dosage

HUMALOG MIX ® 100 IU / ml insulin consisting of 25% insulin lispro and 75% insulin lispro protamine or 50% insulin lispro and 50% insulin lispro protamine, packs of 3 ml:
The correct formulation and the relative dosage to be used varies significantly from patient to patient therefore, even if it is possible to define an optimal therapeutic range, it is advisable that the doctor formulates the correct dose based on the therapeutic needs of the patient, his glycemic levels and his physio-pathological state.
Generally, subcutaneous administration should take place about 15 minutes before main meals.

Warnings HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

In order for insulin therapy to achieve maximum therapeutic success it is advisable for the diabetic patient, adequately instructed by their doctor, to actively participate in the entire treatment.
The correct preparation and administration of insulin represent in fact the first step towards the correct management of the disease, while the ability to recognize the signs of hypoglycemia and to implement adequate remedies protects the patient from potentially dangerous adverse reactions.
Although the patient is the nerve center of the treatment, it is advisable that the doctor carefully supervises his work, guiding the patient and possibly correcting the dosages used in case of incidence of infectious diseases, surgical interventions, lifestyle changes and eating habits and all those other conditions capable of altering the normal insulin requirement.
The possible onset of hypoglycemia could be accompanied by a significant decrease in the patient's perceptive abilities, making the use of machinery and driving cars dangerous.

PREGNANCY AND BREASTFEEDING

The different clinical trials seem to agree on the excellent safety profile of insulin lispro when taken during pregnancy, for the health of the fetus.
It is of fundamental importance to adequately treat the diabetic pregnant woman to safeguard the pregnancy and the correct development of the fetus.

Interactions

The concomitant intake of oral hypoglycemic agents, octreotide, anti-MAO, beta blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids could potentiate the therapeutic effect of insulin lispro, requiring a reduction in the dosage used.
On the contrary, the concomitant administration of oral contraceptives, thiazides, glucorticoids, thyroid hormones and sympathomimetics could reduce the hypoglycemic effect of HUMALOG MIX ® by increasing the need for this hormone.
It is known from the literature that sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.

Contraindications HUMALOG MIX ® - Insulin lispro + insulin lispro protamine

HUMALOG MIX ® contraindicated in case of hypoglycemia and hypersensitivity to human insulin or its excipients.

Undesirable Effects - Side Effects

Subcutaneous insulin intake could be responsible for different local and systemic side effects.
It is in fact possible that bruises, edema, redness and intense itching may occur transiently at the injection site as an index of hypersensitivity to the drug, while clinically more relevant with a classic clinical course is the condition of lipoatrophy which can generally be observed following the failure to rotate the injection sites.
The side effects observed on the gastrointestinal system, the visual system and the haematological picture, present above all in the initial phase of therapy and easily regressed, were rare and without particular complications.
The most frequent and most significant adverse reaction is the condition of hypoglycemia accompanied by the classic symptoms that could rapidly evolve towards loss of consciousness and coma.

Note

HUMALOG MIX ® sold only under medical prescription.
HUMALOG MIX ® falls within the doping class: Hormones and related substances (prohibited in and out of competition)

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