Two active ingredients in a single weekly injection: the combination of insulin and semaglutide has received a positive opinion from the EMA scientific committee. Here’s how it works, what results have been evaluated in clinical trials and what changes for patients.
Fifty-two injections in a year, one every week, instead of a therapy that may require much more frequent administrations. For those who live with the type 2 diabetesthe difference may not just be a question of convenience, but a way to make a treatment that is destined to last over time easier. The news comes from Europe, where the EMA scientific committee expressed a positive opinion on the combination of insulin and semaglutidetwo drugs combined in a single weekly formulation. The objective is ambitious: to keep blood sugar under control, also act on body weight and reduce the daily burden of therapy. An important perspective for a chronic disease that requires constant attention and in which the complexity of treatment can become an obstacle.
Diabetes, two drugs in one injection
The new formulation, developed by the pharmaceutical company Novo under the name IcoSema, combines insulin icodec, which helps control blood sugar, with semaglutidea drug that acts on the mechanisms that regulate blood sugar and contributes to appetite and weight control.
The European opinion represents an important step, but the actual availability in Italy depends on the national access procedures. «Management of type 2 diabetes – explains Francesco Giorgino, full professor of Endocrinology at the University of Bari Aldo Moro – today it cannot be assessed exclusively through the achievement of glycemic targets. The increasing age of the people involved and the frequent presence of cardiovascular, renal, hepatic comorbidities and weight-related problems require an overall approach, oriented towards clinical outcomes and the person’s daily experience. In this context, the new combination takes on importance because it combines complementary mechanisms of action in a single weekly formulation, with the aim of promoting glycemic control and simplifying treatment.”
Type 2 diabetes, the problem of late treatment
In Italy, over four million adults live with diabetes and more than 90 percent of cases concern type 2. Insulin remains a pillar of treatment, but the start of therapy can be delayed for fear of hypoglycemia, concern about weight gain and complexity of treatment plans. It is the phenomenon oftherapeutic inertia: The delay in starting or intensifying treatment when the disease is not adequately controlled. If prolonged, it can compromise the achievement of therapeutic objectives and increase the risk of complications.
A simpler therapy could help overcome some of these barriers. It does not, however, eliminate the need for periodic checks and personalized care, built on the clinical conditions of the individual person.
Clinical studies: blood sugar, weight and hypoglycemia
The combination was evaluated in four international late-stage studies, involving more than 3,000 adults with type 2 diabetes. The trials examined efficacy and safety in people who are not adequately monitored with basal insulin, GLP-1 class drugs or oral antidiabetics.
According to data reported by the company, the studies achieved the primary objective of glycemic control. The effects on body weight and the frequency of hypoglycemic episodes were also evaluated.
The number of administrations is one of the most immediate elements of the novelty: 52 injections per year. However, the comparison with other therapies must be put into context, because the frequency of injections varies based on the treatment prescribed. The results on weight and hypoglycemia must also be read in light of the individual studies and patient characteristics. Security remains central. Insulin can cause hypoglycemia, while semaglutide can cause side effects, especially gastrointestinal. The new formulation is therefore not suitable for all people with diabetes without distinction.
Fewer injections, more quality of life?
Simplifying a treatment also means trying to make it more sustainable in daily life. Fewer administrations could improve adherencebut this benefit will also have to be evaluated in clinical practice, as well as in controlled studies.
«This new therapeutic option is part of the evolution of the management of type 2 diabetes. The achievement of glycemic targets remains essential, but the evaluation of the treatment must also consider the clinical complexity of the person, the frequent presence of cardiovascular, renal and hepatic comorbidities, the body weight and the daily impact of the therapy»adds the diabetologist. «In this context, the integration of basal insulin and a GLP-1 receptor agonist in a single weekly formulation represents an option of interest, because it combines complementary mechanisms of action and can help reduce some barriers to the initiation and intensification of therapy, including the number of administrations and the complexity of the therapeutic schemes. Reducing injection load could support adherence and improve quality of life. Innovation in diabetes care must therefore be evaluated considering, together with effectiveness and safety, the simplicity of the treatment, the clinical appropriateness and the centrality of the person.”
Italy could be among the first European countries to make this innovation available. The actual times will depend on regulatory procedures and decisions by health authorities.
«In this picture – concludes the professor. Giorgio – Italy can once again play an important role in promoting timely and appropriate access to an innovation intended for people with type 2 diabetes, in compliance with the assessments of the competent authorities and the sustainability of the Health Service. In this sense, the hope is that the health authorities of our country will carefully consider this new therapeutic formulation to offer a concrete response to the still unmet needs of people with type 2 diabetes”
