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AIM: To evaluate the real-world effectiveness and safety of insulin glargine 300 U/ml (Gla-300) in achieving glycaemic goals in insulin-naïve people with type 2 diabetes (T2D) in Mexico, Colombia and Peru (Latin America region) in the A Toujeo Observational Study (ATOS). MATERIALS AND METHODS: ATOS was a multicentre, prospective, 12-month observational study, which included 4422 insulin-naïve adults (age ≥ 18 years) with T2D uncontrolled (HbA1c > 7% and ≤11%) on at least one oral antidiabetic drug (OAD) who initiated Gla-300 treatment as per routine practice. The primary endpoint was the percentage of participants achieving their predefined individualized HbA1c goal at month 6. Key secondary endpoints included change from baseline in HbA1c, fasting plasma glucose (FPG), fasting self-monitored blood glucose (SMBG), body weight and incidence of hypoglycaemia. RESULTS: In this subgroup analysis, a total of 314 participants with T2D received Gla-300. At baseline, mean ± SD age was 56.0 ± 11.6 years, duration of diabetes was 9.7 ± 6.6 years and 65.9% of participants were on at least two OADs. The individualized HbA1c target was achieved by 25.8% of participants (95% confidence interval [CI]: 20.3-31.9) at month 6 and by 35.3% (95% CI: 28.5-42.5) at month 12. Gla-300 treatment improved glycaemic control with meaningful reductions in mean HbA1c, FPG and fasting SMBG. The incidence of hypoglycaemia reported was low and body weight remained stable. CONCLUSIONS: In a real-world setting in the Latin America region, the initiation of Gla-300 in people with T2D uncontrolled on OADs resulted in improved glycaemic control with a low incidence of hypoglycaemia and no change in body weight.

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Abstract Background Studies show that among the drugs most commonly used in judicial litigation in Brazil, are those used to treat diabetes mellitus, especially insulin analogues. Objective Evaluate the use of the Unified Health System (SUS) by patients with type 1 diabetes mellitus (T1DM), who receive insulin analogues through judicial action, before and after this process. Method In a retrospective longitudinal observational study, secondary data was used from these patients in Minas Gerais, Brazil, in 2018. Socio-demographic information was collected and related to the follow-up of these patients in the SUS. The McNemar χ2 test was used to compare the proportions of the variables. Results Of the 89 patients analyzed, women (53.9%) were predominant. Most patients were aged between 20 and 39 years (52.8%), and more than half, 55.1%, use only a private health system. After the judicial action, there was a significant increase (p <0.05) in the number of patients who had consultations in primary health care (from 19.1% to 30.3%) and emergency medical appointments (from 1.1% to 9.0%). Conclusion It is observed that the majority of patients with T1DM via judicial action in the SUS are not monitored by this health system through examinations, consultations, and hospitalizations.

Resumo Introdução Estudos mostram que, dentre os medicamentos mais adquiridos via ação judicial, estão os utilizados para o tratamento do Diabetes Mellitus, especialmente os análogos de insulina. Objetivo Avaliar a utilização do Sistema Único de Saúde (SUS) pelos pacientes com Diabetes Mellitus tipo 1 (DM1), que recebem insulina por meio de judicialização, antes e após este processo. Método Em um estudo observacional longitudinal retrospectivo, foram utilizados dados secundários de pacientes com DM1, que adquiriram insulinas por processos judiciais em Divinópolis-MG, Brasil, em 2018. Foram coletadas informações sociodemográficas e referentes ao acompanhamento destes pacientes no SUS Realizou-se o teste χ2 de McNemar para a comparação das proporções das variáveis utilizadas para a avaliação do acompanhamento antes e após a judicialização. Resultados Dos 89 pacientes analisados, predominou-se o sexo feminino (53,9%), com idade entre 20 e 39 anos (52,8%). 55,1% destes utilizam apenas o sistema privado de saúde. Após a judicialização, houve um aumento significativo (p< 0,05) no número de pacientes que realizaram consultas na atenção primária à saúde (de 19,1% para 30,3%) e consultas médicas de emergência (de 1,1% para 9,0%). Conclusão A maioria dos pacientes com DM1 que judicializam medicamentos no SUS não são acompanhados por este sistema de saúde através de realização de exames, consultas e hospitalizações.

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BACKGROUND: Insulin therapy regimens for people with type 1 diabetes (PWT1D) should mimic the physiological insulin secretion that occurs in individuals without diabetes. Intensive insulin therapy, whether by multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII), constitutes the fundamental therapy from the initial stages of type 1 diabetes (T1D), at all ages. This review is an authorized literal translation of part of the Brazilian Diabetes Society (SBD) Guidelines 2021-2022. This evidence-based guideline supplies guidance on insulin therapy in T1D. METHODS: The methods were published elsewhere in earlier SBD guidelines and was approved by the Internal Institutional Steering Committee for publication. Briefly, the Brazilian Diabetes Society indicated fourteen experts to constitute the Central Committee, designed to regulate the method review of the manuscripts, and judge the degrees of recommendations and levels of evidence. SBD Type 1 Diabetes Department drafted the manuscript selecting key clinical questions to do a narrative review using MEDLINE via PubMed, with the best evidence available, including high-quality clinical trials, metanalysis, and large observational studies related to insulin therapy in T1D, by using the Mesh terms [type 1 diabetes] and [insulin]. RESULTS: Based on extensive literature review the Central Committee defined ten recommendations. Three levels of evidence were considered: A. Data from more than one randomised clinical trial (RCT) or one metanalysis of RCTs with low heterogeneity (I2 < 40%). B. Data from metanalysis, including large observational studies, a single RCT, or a pre-specified subgroup analysis. C: Data from small or non-randomised studies, exploratory analysis, or consensus of expert opinion. The degree of recommendation was obtained based on a poll sent to the panellists, using the following criteria: Grade I: when more than 90% of agreement; Grade IIa if 75-89% of agreement; IIb if 50-74% of agreement, and III, when most of the panellist recommends against a defined treatment. CONCLUSIONS: In PWT1D, it is recommended to start insulin treatment immediately after clinical diagnosis, to prevent metabolic decompensation and diabetic ketoacidosis. Insulin therapy regimens should mimic insulin secretion with the aim to achieve glycemic control goals established for the age group. Intensive treatment with basal-bolus insulin therapy through MDI or CSII is recommended, and insulin analogues offers some advantages in PWT1D, when compared to human insulin. Periodic reassessment of insulin doses should be performed to avoid clinical inertia in treatment.

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Introducción: La insulina es un importante fármaco que puede ser empleado en el tratamiento del paciente diabetes mellitus tipo 2. Objetivo: Describir algunas de las características del tratamiento con insulina en el paciente con diabetes mellitus tipo 2. Métodos: La información necesaria para redactar el presente artículo se obtuvo en el trimestre octubre-diciembre de 2020. Se utilizó como motores de búsqueda de información científica a Google Académico, Pubmed y Scielo. Se evaluaron diferentes trabajos de revisión, de investigación y páginas web, que en general tenían menos de 10 años de publicados, en idioma español, portugués o inglés. Fueron utilizadas como palabras clave: tratamiento; insulina; análogos de insulina; diabetes mellitus. Fueron excluidos los artículos que no reunían las condiciones señaladas. Esto permitió el estudio de 80 artículos, de los cuales 43 fueron referenciados. Conclusiones: La insulina es una hormona polipeptídica sintetizada por las células β de los islotes de Langerhans del páncreas. Su efecto es ejercido fundamentalmente a nivel del hígado, tejido adiposo y músculo, y es una opción terapéutica en cualquier fase evolutiva de la diabetes mellitus tipo 2, cuando los agentes orales no logran las metas o si se presentan ciertas complicaciones. Se dispone de una amplia gama de tipos de insulina con distintos perfiles de acción y concentración, lo que permite clasificarlas de diferentes maneras. Se han establecido diferentes criterios sobre cuándo se debe comenzar y cómo orientar el tratamiento con insulina en la persona con diabetes mellitus tipo 2, lo que hacen posible un mejor control glucémico(AU)

Introduction: Insulin is an important drug that can be used for providing treatment to the patient with type 2 diabetes mellitus. Objective: To describe some of the characteristics of insulin treatment in patients with type 2 diabetes mellitus. Methods: The necessary information for writing this article was obtained in the trimester October-December 2020. As search engines for scientific information, Google Scholar, Pubmed and SciELO were used. Different review papers, research papers and web pages were assessed, generally less than ten years old and published in Spanish, Portuguese or English. The following keywords were used: tratamiento [treatment], insulina [insulin]; análogos de insulina [insulin analogues], diabetes mellitus. The articles not meet the above conditions were excluded. This allowed the study of eighty articles, of which 43 were referenced. Conclusions: Insulin is a polypeptide hormone synthesized by the β cells of the islets of Langerhans of the pancreas. Its effect is produced primarily at the liver, adipose tissue and muscle levels. It is a therapeutic option in any evolutionary phase of type 2 diabetes mellitus, when oral agents fail to achieve goals or if certain complications occur. A wide range of insulin types with different action and concentration profiles are available, allowing them to be classified in different ways. Different criteria have been established about when to start and how to guide insulin treatment in the person with type 2 diabetes mellitus, making better glycemic control possible(AU)

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OBJECTIVE: The aim of this study was to evaluate the frequency of hypoglycemia and the treatment satisfaction in patients with type 1 diabetes (T1D) using insulin analogues. METHODS: This observational retrospective study included 516 adult patients with T1D from 38 cities in Southern Brazil. Demographics and clinical data were collected using a self-report questionnaire. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and with a specific question with scores ranging from 0-10. Common mental disorders were assessed using the General Health Questionnaire (GHQ-12). RESULTS: Overall, the mean age was 38 ± 14 years and 52% of the participants were women. The median diabetes duration was 18 years. The scores for insulin analogue treatment satisfaction were higher than those for previous treatments. DTSQ scores had a median value of 32 (interquartile range 29-35) and remained unchanged over time. The percentage of patients with hypoglycemia (including severe and nocturnal) was comparable across groups divided according to duration of use of insulin analogues. Most patients (n=395, 77%) screened positive for common mental disorders. CONCLUSION: Patient satisfaction with insulin analogue treatment was high and remained unchanged with time. Episodes of hypoglycemia also remained unchanged over time among patients using insulin analogues.

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ABSTRACT Objective: The aim of this study was to evaluate the frequency of hypoglycemia and the treatment satisfaction in patients with type 1 diabetes (T1D) using insulin analogues. Subjects and methods: This observational retrospective study included 516 adult patients with T1D from 38 cities in Southern Brazil. Demographics and clinical data were collected using a self-report questionnaire. Hypoglycemia was defined as an event based on either symptoms or self-monitored blood glucose < 70 mg/dL. Treatment satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and with a specific question with scores ranging from 0-10. Common mental disorders were assessed using the General Health Questionnaire (GHQ-12). Results: Overall, the mean age was 38 ± 14 years and 52% of the participants were women. The median diabetes duration was 18 years. The scores for insulin analogue treatment satisfaction were higher than those for previous treatments. DTSQ scores had a median value of 32 (interquartile range 29-35) and remained unchanged over time. The percentage of patients with hypoglycemia (including severe and nocturnal) was comparable across groups divided according to duration of use of insulin analogues. Most patients (n=395, 77%) screened positive for common mental disorders. Conclusions: Patient satisfaction with insulin analogue treatment was high and remained unchanged with time. Episodes of hypoglycemia also remained unchanged over time among patients using insulin analogues.

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AIM: To investigate the external validity of recent antihyperglycaemic trials evaluating cardiovascular outcomes in a multimorbid population. MATERIALS AND METHODS: Selection criteria of 15 randomized controlled trials from the 2020 American Diabetes Association Standard of Care statement were applied in a stepwise manner to tertiary care patients with type 2 diabetes. Primary outcomes were the number of patients eligible per individual trial and for the aggregate of trials. Secondary outcomes included patient predictors of trial eligibility. RESULTS: Of 1059 patients, the mean (SD) age was 66 (10.74) years, the median (IQR) Charlson index was 2 (2, 3) and 458 (43%) had documented cardiovascular disease. The median (IQR) number of patients included in individual trials was 263 (174.25-308.75) and 795 (75.1%) of them were eligible for at least one trial. Among those 264 ineligible, 127 (48.1%) had an HbA1c level of 7% or less and no cardiovascular disease; 53.5% and 34.4% of the patients were eligible for two and three different classes of drugs, respectively. The strongest predictor of trial eligibility was cardiovascular disease (risk ratio 2.17, 95% CI 2.01-2.35). CONCLUSIONS: A considerable proportion of multimorbid patients would be eligible for recent antihyperglycaemic trials. This positive finding can be attributed to development guidance in diabetes trials and the different approach we took, in which we evaluated inclusion by trials as an aggregate.

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Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec, which provides long-lasting basal insulin coverage, and insulin aspart, which targets postprandial glycaemia. This review provides expert opinion on the practical clinical use of IDegAsp, including: dose timings relative to meals, when and how to intensify treatment from once-daily (OD) to twice-daily (BID) dose adjustments, and use in special populations (including hospitalized patients). IDegAsp could be considered as one among the choices for initiating insulin treatment, preferential to starting on basal insulin alone, particularly for people with severe hyperglycaemia and/or when postprandial hyperglycaemia is a major concern. The recommended starting dose of IDegAsp is 10 units with the most carbohydrate-rich meal(s), followed by individualized dose adjustments. Insulin doses should be titrated once weekly in two-unit steps, guided by individualized fasting plasma glucose targets and based on patient goals, preferences and hypoglycaemia risk. Options for intensification from IDegAsp OD are discussed, which should be guided by HbA1c, prandial glucose levels, meal patterns and patient preferences. Recommendations for switching to IDegAsp from basal insulin, premixed insulins OD/BID, and basal-plus/basal-bolus regimens are discussed. IDegAsp can be co-administered with other antihyperglycaemic drugs; however, sulphonylureas frequently need to be discontinued or the dose reduced, and the IDegAsp dose may need to be decreased when sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists are added. Considerations around the initiation or continuation of IDegAsp in hospitalized individuals are discussed, as well as in those undergoing medical procedures.

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BACKGROUND: Diabetes treatment requires specialized multi-professional teams, supplies for blood glucose monitoring and training for self-injections of human insulin or insulin analogues. The State Health Secretariat of the Federal District (SHS-FD) has dispensed insulin analogues by means of clinical validated protocols since 2004. However, data on outcomes of follow-up are still unknown. OBJECTIVE: To evaluate the results of glycated hemoglobin (HbA1c) among diabetic patients treated with insulin analogues. METHODS: It is a retrospective cohort study involving data of type 1(DM1) and type 2 diabetes (DM2) patients 18 years old and above who were registered to participate at the insulin analogues dispense program of the SHS-FD. Evaluation of criteria of insulin treatment continuity was based on HbA1c values achieved in the follow-up period: in the target, <7 %, patients between 18 and 65 years old; <8 % for those above 65 years old; out of target, when values were superior these cut off points for both age groups; and minimum 0.5 % reduction of two HbA1c values during follow-up. RESULTS: Two hundred and fifteen formularies were analyzed: Type 2 patients (63.7 %) and female sex were the most prevalent (63.7 %), (p < 0.05). Mean age and SD were 41.5 ± 23.5 years among DM1 and 60.5 ± 28.5 in those with DM2. HbA1c in the target was found in 26 %, 48 % were out of target and 26 % achieved 0.5 % minimum reduction in HbA1c value (p < 0.05). The main clinical characteristics associated with HbA1c found to be in the target were older age (>65 years), more than three medical appointments in the follow-up and lower mean HbA1c in the patient selection for inclusion criteria in the dispense program (p < 0.05). CONCLUSION: The low number of patients using insulin analogues in the target group, considered to be in good control, implies the need to reevaluate both level of patients self-care knowledge and glucose monitoring prior their inclusion in the insulin analogue dispense program. Reinforcement and training of health professional teams in enrollment procedures should be on mandatory basis to avoid protocol failure or deviations.

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The development of extended-action insulin analogues was motivated by the unfavorable pharmacokinetic (PK) profile of the conventional long-acting insulin formulations, generally associated with marked inter and intra patient variability and site- and dose-dependent effect variation. The new ultra-long insulin analogue degludec (IDeg) has the same amino acid sequence as human insulin except for the removal of threonine in the position 30 of the B chain (Des-B30, "De") and the attachment, via a glutamic acid linker ("glu"), of a 16-carbon fatty diacid (hexadecanoic diacid, "dec") to lysine in the position 29 of the B chain. These modifications allow that, after changing from the pharmaceutical formulation to the subcutaneous environment, IDeg precipitates in the subcutaneous tissue, forming a depot that undergoes a highly predictable gradual dissociation. Thus, once-daily dosing of IDeg results in a low peak: trough ratio, with consequent low intra-individual variability and plasmatic concentrations less critically dependent upon the time of injections. The clinical development program of IDeg (BEGIN) was comprised of 9 therapeutic confirmatory trials of longer duration (26-52 weeks) and showed that the efficacy of IDeg is comparable to insulin glargine in type 1 (T1D) and type 2 (T2D) diabetes patients across different age, body mass index and ethnic groups. This new ultra-long insulin analogue presents as advantages flexibility in dose timing and lower risk of hypoglycemia.

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Los análogos de la insulina se han usado en el tratamiento de la diabetes asociada al embarazo, aún sin la aprobación de instancias reguladoras. Con el fin de conocer su eficacia y seguridad materno-fetal, se realizó la revisión bibliográfica sobre el tema. En cuanto a la Glulisina, no hay reporte de su uso en la gestación. Con Lispro, hay pocos estudios aleatorios donde se compare su uso con insulina humana regular, pero hay variados estudios observacionales en su mayoría retrospectivos, que no revelan aumento de riesgo. Referente a Aspart, se ha investigado en mujeres con diabetes tipo 1 durante el embarazo mediante un ensayo clínico aleatorio controlado, donde se compara con insulina humana regular, cuyos resultados sirvieron de base para la aprobación de su uso en gestantes. Con Glargina, se han llevado a cabo estudios observacionales, pero no aleatorios controlados y con Detemir, se finalizó el año 2011 un estudio aleatorio controlado, comparando con insulina humana NPH, cuyos resultados sustentaron la reciente aprobación por la Federal Drug Administration para su uso en embarazadas. En conclusión, Lispro y Aspart constituyen las opciones de análogos de acción rápida a usar durante el embarazo cuando no sea posible controlar las elevaciones postprandiales de la glucemia o prevenir hipoglucemias nocturnas y severas con insulina humana. El análogo de acción larga Detemir podrá ser usado durante el embarazo, una vez aprobado por los organismos nacionales correspondientes. Se requieren estudios aleatorios controlados en embarazadas para Glargina y de costo-efectividad para todos los análogos de la insulina.

Insulin analogues have been used in the treatment of diabetes in pregnancy and some of them off-label. To know the efficacy and safety of insulin analogues concerning mother and fetus, a literature review on the subject was carried out. Regarding Glulisine, there are no reports on its use on gestation. On Lispro, there are few randomized studies comparing its use to regular human insulin, however, there are several observational studies, mostly retrospective, that do not reveal an increased risk. On Aspart, research has been done on women with type 1 diabetes during pregnancy with a randomized controlled clinical trial comparing it to regular human insulin; its results were used as a basis for its approval in pregnant women. On Glargine, observational studies have been carried out, but none were randomized controlled. On Detemir, a randomized controlled trial that ended in 2011 was carried out, comparing it to NPH human insulin; its results supported the recent approval by the Federal Drug Administration (FDA) to be used in pregnant women. In conclusion, Lispro and Aspart are the options of fast-action analogues for use during pregnancy when the control of glucose postprandial elevations or the prevention of nocturnal and severe hypoglycemia with human insulin is not possible. The long-lasting analogue Detemir may be used during pregnancy, once it has been approved by national drug regulations. Randomized controlled studies during pregnancy are required for Glargine and cost-efficacy studies for all insulin analogues.

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Pregnancy affects both maternal and fetal metabolism, and even in non-diabetic women, it exerts a diabetogenic effect. Among pregnant women, 2% to 14% develop gestational diabetes. Pregnancy can also occur in women with preexisting diabetes, which may predispose the fetus to many alterations in organogenesis, restrict growth, and the mother, to some diabetes-related complications, such as retinopathy and nephropathy, or to acceleration of the course of these complications, if they are already present. Women with gestational diabetes generally start their treatment with diet and lifestyle changes; when these changes are not enough for optimal glycemic control, insulin therapy must then be considered. Women with type 2 diabetes using oral hypoglycemic agents are advised to change to insulin therapy. Those with preexisting type 1 diabetes should start intensive glycemic control. As basal insulin analogues have frequently been used off-label in pregnant women, there is a need to evaluate their safety and efficacy. The aim of this review is to report the use of both short- and long-acting insulin analogues during pregnancy and to enable clinicians, obstetricians, and endocrinologists to choose the best insulin treatment for their patients.

A gravidez afeta tanto o metabolismo materno quanto o fetal e, mesmo em mulheres não diabéticas, apresenta um efeito diabetogênico. Entre as mulheres grávidas, 2% a 14% desenvolvem o diabetes gestacional. A gravidez pode ocorrer também em mulheres já diabéticas, o que pode predispor o feto a muitas alterações na organogênese, restrição de crescimento e a mãe a algumas complicações relacionadas ao diabetes, tais como retinopatia e nefropatia, ou acelerar o curso dessas complicações se já estiverem presentes. Pacientes com diabetes gestacional geralmente iniciam seu tratamento com dieta e mudanças no estilo de vida; porém, quando essas medidas falham em atingir um controle glicêmico adequado, a insulinoterapia deve ser considerada. Pacientes com diabetes tipo 2 em uso de hipoglicemiantes orais são aconselhadas a iniciar o uso de insulina. Pacientes com diabetes tipo 1 preexistente devem iniciar um controle glicêmico estrito. Em função do fato de os análogos basais de insulina estarem sendo utilizados muito frequentemente off-label em pacientes grávidas, faz-se necessário avaliar sua segurança e eficácia nessa condição. O objetivo desta revisão é avaliar o uso de tais análogos, tanto de ação curta como prolongada, durante a gravidez, para possibilitar médicos clínicos, obstetras e endocrinologistas escolher o melhor regime terapêutico para suas pacientes.

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La diabetes es una patología difícil de tratar. Actualmente la insulina sigue siendo el pilar fundamental, y las estrategias de tratamiento de reemplazo tienen por finalidad reproducir el perfil de secreción normal de insulina, para lograr así el control efectivo en los niveles de glucemia basal y postprandial. Con una combinación adecuada de análogos de insulina, se puede lograr ése control óptimo de la glucemia, recomendado por las diferentes asociaciones y organizaciones mundiales, dedicadas al estudio y control de la diabetes. En este artículo se realiza una revisión sobre la fisiopatología de la diabetes mellitus Tipo 1 y Tipo 2, como base para dirigir el tratamiento usando las nuevas insulinas (análogos), en cada una de ellas. Pero necesitamos superar los mitos y las barreras, que tienen los médicos y sus pacientes, a los regímenes de tratamiento con insulina.

Diabetes is a difficult disease to treat. Currently, insulin is still the mainstay. Treatment strategies are aimed to reproduce the normal secretory profile of insulin to achieve the effective control in the fasting and postprandial plasma glucose levels. Mostly, with an appropriate combination of insulin analogues, an optimal control of blood sugar could be achieved, such as recommended by the different worldwide associations and organizations, dedicated to the study and control care of diabetes. This article is a review of the pathophysiology of Type 1 and Type 2 diabetes mellitus as the support for treatment in each one of its, but we still need to dispel myth and removing barriers of acceptance about these insulin regimens treatments in physicians and patients.