Insulin icodec: A novel once-weekly treatment for diabetes.

AIMS: To summarize the results of clinical studies of insulin icodec, an investigational insulin analog designed for once-weekly administration, in adults with type 1 and type 2 diabetes. METHODS: Thirteen published articles describing clinical studies of insulin icodec were identified in PubMed, and data pertinent to key study outcomes were selected for inclusion in this review. RESULTS: In insulin-naïve and insulin-treated individuals, icodec demonstrated efficacy in glycaemic control superior or noninferior to that of insulins glargine U100, glargine U300 and degludec. Icodec exhibited a safety profile comparable to marketed insulins, with the exception of hypoglycaemic event rates. CONCLUSIONS: As a once-weekly alternative to daily basal insulin, icodec is expected to improve patient adherence and satisfaction, reducing the required number of injections per year from 365 to 52 and providing a dosing option potentially attractive to a wide range of insulin users. However, clinical data suggest a notable risk of hypoglycaemia with weekly icodec administration, especially in individuals with type 1 diabetes.

Once-Weekly Insulin Icodec vs. Once-Daily Insulin Glargine U100 for type 2 diabetes: a systematic review and meta-analysis of phase 2 randomized controlled trials

ABSTRACT Objective: Insulin Icodec is a novel basal insulin analogue designed for once-weekly administration, therefore might propitiate reduction in the frequency of injections and facilitate treatment adherence. This study aimed to determine the glycemic control and safety profile of Insulin Icodec, compared with Glargine U100 in patients with diabetes mellitus type 2. Materials and methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCT) data comparing Once-Weekly Insulin Icodec and Once-Daily Insulin Glargine U100 in patients with type 2 diabetes mellitus. PubMed, Embase, and Cochrane databases were searched for trials published up to May 14, 2022. Data were extracted from published reports and quality assessment was performed per Cochrane recommendations. Results: Three studies were included comprising 453 patients, 230 (50.77%) using Once-Weekly Insulin Icodec and 223 (49.22%) using Once-Daily Insulin Glargine U100. In the pooled data, Glycated Hemoglobin (MD -0.20% CI -0.33 to -0.07%; P=0.002) change from baseline demonstrated a significantly higher reduction in the Icodec group. Time with Glucose in Range (MD 6.60% CI 3.63 to 9.57%; P < 0.0001) and Insulin Dose Difference (MD 0.97UI CI 0.76 to 1.18UI; P < 0.0001) were higher in the Icodec group. There was no significant difference in fasting plasma glucose, body weight change, hypoglycemia or any adverse event evaluated. Conclusions: Once-Weekly Insulin Icodec was associated with a small reduction in Glycated Hemoglobin, as well as higher Time with Glucose in Range, with similar hypoglycemic adverse events, when compared with Once-Daily Insulin Glargine U100.

Long-acting insulin in a public health system: analysis of compliance with clinical protocol in public pharmacies / Insulina de ação prolongada no sistema público de saúde: análise da adesão ao protocolo clínico em farmácias públicas

Abstract Diabetes mellitus (DM) is a chronic disease marked by elevated blood glucose levels. Controlling DM involves adequate diet, physical exercises, medicines and monitoring the blood glucose and glycated hemoglobin (HbA1c) levels. This was a retrospective study of the process of dispensing long-acting insulin analogues to users with diabetes (types 1 and 2) who were registered at high-cost public pharmacies in public health system in a southeast state of Brazil, that sought to evaluate the fulfillment of the criteria of all the clinical protocol to provide these analogs. Of the 987 users registered in the health service, 315 met the inclusion criteria for the study. The evaluation of the dispensing processes of the long-acting insulin analogues revealed that the inclusion, exclusion, and suspension criteria of the protocol related with these insulin analogues were in some extend only partially fulfilled. Additionally, there was no difference between the initial and final fasting glycemic and HbA1c levels. It is concluded that the established criteria for dispensing long-acting insulin analogues were partly fulfilled by pharmacies, compromising the rational use of these analogues. It can directly impact the cost of maintaining the public health service and users' health.

Resumo Diabetes mellitus (DM) é uma doença crônica marcada por níveis sanguíneos elevados de glicose. O controle do DM envolve dieta adequada, exercícios físicos, medicamentos e monitoramento dos níveis sanguíneos de glicose e de hemoglobina glicada (HbA1c). Trata-se de um estudo retrospectivo do processo de dispensação de análogos de insulina de ação prolongada a usuários com diabetes (tipos 1 e 2) cadastrados em farmácias públicas de alto custo do sistema público de saúde de um estado do Sudeste do Brasil, que buscou avaliar o cumprimento dos critérios do protocolo clínico para fornecimento desses análogos. Dos 987 usuários cadastrados no serviço de saúde, 315 preencheram os critérios de inclusão. A avaliação dos processos de dispensação dos análogos de insulina de ação prolongada revelou que os critérios de inclusão, exclusão e suspensão do protocolo dos análogos de insulina eram parcialmente cumpridos. Além disso, não houve diferença entre os níveis inicial e final de glicemia em jejum e HbA1c. Conclui-se que os critérios estabelecidos para dispensação de análogos de insulina de ação prolongada foram parcialmente cumpridos pelas farmácias, comprometendo o uso racional dos análogos. Os achados podem impactar diretamente no custo de manutenção do serviço público de saúde e na saúde do usuário.

Efecto de la lipohipertrofia en el control metabólico de pacientes con diabetes mellitus tipo 2 / Effect of lipohypertrophy on the metabolic control of patients with type 2 diabetes mellitus

Resumen La lipodistrofia (lipohipertrofia, lipoatrofia) es una complicación dada por la técnica inadecuada de inyección subcutánea de insulina. Se presenta el caso de una paciente de 46 años con diabetes mellitus tipo 2 descontrolada, en tratamiento con insulina glargina 45UI/día, sin control glucométrico y con múltiples ajustes y hospitalizaciones. Al ingreso, el automonitoreo muestra glucometrías basales y posprandiales fuera de metas, glucemia basal de 299 mg/dL y HbA1c de 11%. Al interrogatorio, se evidencian fallas en la técnica de aplicación de insulina, en particular falta de rotación del sitio de aplicación. En el examen físico se encuentra lipohipertrofia dada por panículo adiposo infraumbilical prominente bilateral e induración del tejido celular subcutáneo; en ecografía se visualiza infiltración grasa de rectos anteriores. Se da instrucción a la paciente sobre la correcta técnica de aplicación de insulina con rotación diaria del sitio de aplicación, descanso de zonas con lipohipertrofia y guía para automonitoreo. El automonitoreo en los 10 primeros días mostró mejoría de glucometrías basales hasta 116 mg/dL y valor limítrofe de 75 mg/dL, comparados con promedio de glucometría basal previa de 242 mg/dL con la misma insulina y dosis. Se hizo seguimiento estrecho para definir dosis requerida de insulina y vigilar posible hipoglucemia, con mejoría en la HbA1c de 9.2% y 8.8% a los 4 y 11 meses, respectivamente.

Abstract Lipodystrophy (lipohypertrophy, lipoatrophy) is one of the most common complications of subcutaneous insulin injections. This paper presents the case of a 46-year-old patient with uncontrolled type 2 diabetes mellitus, treated with insulin glargine 45UI/day, no glycemic control and multiple adjustments and hospitalizations. On admission, self-monitoring showed off-target basal and postprandial values, baseline glucose of 299 mg/dL and HbA1c of 11%. Medical history revealed flaws in the technique used for insulin administration, particularly, lack of application site rotation. Physical examination allowed to observe lipohypertrophy caused by excess bilateral infraumbilical adipose panniculus and induration of the subcutaneous cellular tissue. Ultrasound exposed fat infiltration in anterior recti. The patient was instructed on the correct technique for applying insulin with daily rotation of the application site, and allowing the areas affected by lipohypertrophy to rest. A self-monitoring guide was also provided. Self-monitoring within the first 10 days showed improvement in baseline glucose levels up to 116 mg/dL and borderline value of 75 mg/dL, compared to the previous baseline blood glucose level of 242 mg/dL with the same type of insulin and dose. Close follow-up was done to define the required insulin dose and to monitor possible hypoglycemia, obtaining an improvement in HbA1c of 9.2% and 8.8% at 4 and 11 months, respectively.