Home > For Consumers > Insulin degludec (Tresiba) for diabetes...

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.

Informed Health Online [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-.

Informed Health Online [Internet].

Insulin degludec (Tresiba) for diabetes in teenagers and children: Overview

Created: June 1, 2015; Next update: 2018.

Introduction

In 2015 insulin degludec (trade name: Tresiba) was approved in Germany for the treatment of type 1 and type 2 diabetes in teenagers and children over the age of one. This drug is a long-acting insulin analogue. It is used to regulate blood sugar levels for up to 24 hours.

Diabetes is a metabolic disease that affects many different parts of the body. In people with type 1 diabetes, the pancreas can only produce insulin in small quantities or not at all. Regular injections are needed to supply the body with enough insulin. In type 2 diabetes, the pancreas produces enough insulin at first, but the cells of the body become increasingly unable to absorb and use it. If blood sugar levels cannot be lowered enough by changes in diet and exercise, blood-sugar-lowering drugs are used.

This new treatment is supposed to prevent strong fluctuations in blood sugar levels and the unpleasant effects of high and low blood sugar in children and teenagers with diabetes. It is also meant to help prevent complications that may arise if blood sugar levels are too high.

In people with type 1 diabetes, the long-acting insulin degludec is taken at mealtimes in combination with a short-acting insulin. In children and teenagers with type 2 diabetes, it can be used on its own or together with a different short-acting insulin (taken with meals) or blood-sugar-lowering tablets. A triple combination with insulin and tablets is also possible.

Application

Insulin degludec is injected into the skin once a day using an insulin pen. The drug is available in ready-to-use pens or cartridges in various doses: The dose depends on a number of factors, including the additional blood-sugar-lowering treatment, current blood sugar levels and the future blood sugar level goal. It must be adjusted on an individual basis.

Other treatments

Human insulin is used as a standard treatment for children and teenagers with type 1 diabetes. Human insulin or a combination of human insulin and the drug metformin are possible options for children and teenagers with type 2 diabetes.

Assessment

In 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed the possible advantages and disadvantages of insulin degludec for children over the age of one and teenagers with type 1 or type 2 diabetes, used either on its own or in the approved combinations with other medications, when compared to established standard therapies.

The manufacturer did not provide any suitable data about children and teenagers with type 2 diabetes, so it is not possible to determine whether insulin degludec provides any added benefits in comparison with standard therapies for these groups of people.

For children and teenagers with type 1 diabetes, the manufacturer provided a study involving 350 participants. One group of participants received the insulin analogues insulin degludec and insulin aspart, and the other group received the insulin analogues insulin detemir and insulin aspart. Based on this study, conclusions can be drawn regarding the comparison with the standard therapy (human insulin). The results of these studies are presented below.

What are the disadvantages of insulin degludec?

  • Severe side effects: There is weak evidence that treatment with insulin degludec may have disadvantages for girls with type 1 diabetes. Girls who used insulin degludec had more severe side effects than girls who used insulin detemir. About 15 out of 100 girls who used insulin degludec had severe side effects over the course of 52 weeks. This was the case in about 3 out of 100 girls who had the standard therapy. Severe side effects were equally common in both groups of boys with type 1 diabetes.

Where was there no difference?

  • Life expectancy: No participants died during the study.
  • Complications: The study did not last long enough to assess the effect of insulin degludec on microvascular complications such as retinopathy (retinal damage), neuropathy (nerve damage), or nephropathy (kidney damage). A measurement known as the HbA1c level shows the average blood sugar level over the last two to three months. It is currently believed that HbA1c levels influence the risk of developing the above-mentioned complications, so IQWiG considers favorable HbA1c levels to be an indication of a possible added benefit. The HbA1c levels were the same in both treatment groups in the study.
  • Treatment stopped because of side effects: Very few children and teenagers stopped treatment due to side effects. There was no noticeable difference between insulin degludec and insulin detemir here.
  • Changes in metabolism: Acidosis due to ketone bodies (ketoacidosis) and severe or symptomatic hypoglycemia were equally common in both treatment groups.

What remains unanswered?

  • Quality of life: The study did not look into effects on quality of life, so the advantages and disadvantages of the drug are not clear here.
  • Symptomatic hyperglycemia: It was not possible to tell how often hyperglycemia was caused by insulin degludec treatment compared with insulin detemir. The study did not provide any data on this side effect.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of insulin degludec (Tresiba).

Sources

  • Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Insulin degludec (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V. Dossier assessment A15-10. Cologne: IQWiG. May 28, 2015.
  • IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

    Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. We do not offer individual consultations.

    Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

© IQWiG (Institute for Quality and Efficiency in Health Care)

Download

IQWiG (Institute for Quality and Efficiency in Health Care)

PubMed Health Blog...

read all...

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...