Report on Insulin Degludec Tresiba

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Report on Insulin Degludec Tresiba

This document summarizes the European Evaluation Public Report (EPAR) of Tresiba.In it I know
Explain how the Human Use Medicines Committee (CHMP) has evaluated this medication and
issued a favorable opinion for its marketing authorization and some recommendations on
the conditions of its use.

What is Tresiba?
Tresiba is a medicine that contains the active substance insulin swallow.It is presented in solution
injectable in a cartridge (100 units/ml) and in preloaded pen (100 units/ml and
200 units/ml).

Why is threeiba used?
Tresiba is used to treat type 1 diabetes and type 2 in adults and in children between 1 and 18
years.
This medicine can only be dispensed with a medical recipe.

How is threeiba used?
Tresiba must be injected once a day, preferably at the same time every day.Tresiba se
administers subcutaneously by injection into the thigh, the upper arm or wall area
abdominal (on the front of the waist).The injection point should always be changed
within the same area to reduce the risk of lipodystrophy (alterations in the distribution of the
body fat) under the skin, which can affect the amount of insulin that is absorbed.
The correct dose is determined individually for each patient.In type 1 diabetes,
Tresiba should always be used in combination with a rapid action insulin that is injected
During meals.In type 2 diabetes, Tresiba can be administered in monotherapy or in combination with antidiabetics administered orally, agonists of the GLP-1 receiver and a rapid action insulin in meals.

How does Tresiba act?
Diabetes is a disease in which the organism does not produce sufficient insulin to control
Blood glucose concentrations or is unable to use insulin effectively.Tresiba is
A substitute for insulin that resembles natural insulin with the difference that it is
absorbed more slowly in the body and needs more time to achieve its objective.This
It means that Tresiba has a long period of action.Tresiba acts in the same way as
insulin produced naturally and contributes to glucose pass from blood to the interior of the
CellsControlling blood glucose concentration allows you to reduce symptoms and complications
of diabetes.

What kind of studies have been done with Tresiba?
Tresiba has been studied in three main studies in which 1,578 adults with diabetes participated
of type 1 in which Tresiba was compared (in combination with a rapid action insulin in the
meals) with the insulin Glargina or the Insulin Detemir (other prolonged action insulins).
In six other main studies in which 4 076 adults participated with type 2 diabetes
compared threeiba with glargine insulin, hensulin detemir or sigliptin (a medication that is
Take orally for type 2 diabetes).If necessary, it could also be administered to
Patients other diabetes medications or fast -acting insulin during meals.Other
main study in which 177 adults participated with type 2 diabetes investigated the effectiveness of
Combine Tresiba and Liraglutida (a GLP-1 receiver agonist).
Tresiba also compared to the insulin to stop in a main study in which 350 participated
Children between 1 and 18 years with type 1 diabetes. Patients were also administered insulin
fast action during meals.After 26 weeks of treatment, patients could well
Interrupt the treatment or continue it for a maximum period of one year.
AllThe studies measured the blood concentrations of a substance called hemoglobin
glycosilada (HBA1C), which is the percentage of blood hemoglobin linked to glucose.HBA1C
It provides an indication of to what extent glycemia is well controlled.The studies lasted six
months or a year.

What benefits has shown to have threeiba during the studies?
The studies have shown that threeiba was at least as effective as the other insulins of
Prolonged action for glycemia control in adults with type 1 and type 2 diabetes
that sigliptin in adults with type 2 diabetes. In all studies the average reduction of
HBA1C levels with Tresiba was 0.6 % in adults with type 1 diabetes and 1.2 % in adults
with type 2 diabetes.

In children, the effects of Tresiba on glycemia control were similar to those of insulin
Count.After 26 weeks of treatment with Tresiba, the average reduction of HBA1C levels was
of 0.2 % (HBA1C went from 8.2 % to 8.0 %) compared to the 0.3 % reduction in the case of
Insulin Detemir (HBA1C went from 8.0 % to 7.7 %).

What is the risk associated with Tresiba?
The most frequent adverse effect of threeiba (observed in more than one patient of every 10) is the
Hypoglycemia (low blood glucose concentrations).
To consult the complete list of adverse effects and restrictions of Tresiba, see the prospect.

Why has Tresiba been approved?
The CHMP concluded that Tresiba is effective in controlling blood glucose concentrations in
Patients with type 1 diabetes and type 2. With regard to their safety, the committee concluded that
Tresiba is, in general, safe and that its adverse effects are comparable to those observed in others
Analogues of insulin, without unexpected adverse effects.It also fits
Highlight that Tresiba reduces the risk of night hypoglycemia in patients with type 1 diabetes and
of type 2. The CHMP indicated that the formulation of greater concentration of threeiba satisfied a
medical need in patients who require higher doses of insulin (such as patients with
overweight), which would allow these patients to take the daily dose in a single injection instead of
in two.For teenagers with type 2 diabetes, the CHMP concluded that although security and
Effectiveness had only been shown for type 1 diabetes, the results of the studies in
teenagers with type 1 and other studies in adults with type 2 could be applied to adolescents with
Type 2 diabetes. The CHMP decided that the benefits of threeiba are greater than their risks and
recommended authorizing its commercialization.

What measures have been adopted to guarantee a safe and effective use of Tresiba?
A risk management plan has been developed to ensure that Tresiba is administered in a way
as sure as possible.Based on this plan, it has been included in the summary of the characteristics of the
Product and the three -year prospect for security information that includes precautions
relevant to health professionals and patients.

The company that markets threeiba will provide educational material to health professionals
responsible for treating or dispensing medications to diabetics, intended in particular to increase
Information on the formulation of the new concentration of threeiba to ensure that
The right dose is prescribed to the patient.It will also provide patients with training material with
Instructions on the correct use of Tresiba, which must be delivered by the doctor, in addition to
Receive adequate training.

Other information about Tresiba
The European Commission issued a valid marketing authorization throughout the European Union for
Tresiba on 21January 2013.

The complete EPAR of Tresiba can be consulted on the agency's website: Ema.europa.eu/find
Medicine/Human Medicines/European Public Assessment Reports.For more information about the
TRUEBA TREATMENT, READ THE PROSPECT (also included in EPAR) or consult your doctor or
pharmacist.