Second-Generation Insulin Analogues - a Review of Recent Real-World Data and Forthcoming Head-to-Head Comparisons

Altres ajuts: Editorial assistance was provided by Touch Medical Media and was funded by Sanofi.Insulin analogues play a key role in the effective management of type 2 diabetes. However, there are several behavioural barriers to appropriate early initiation of insulin therapy, despite compelling evidence supporting the benefits of this strategy in those patients for whom oral anti-diabetes agents provide insufficient control. The development of second-generation insulin analogues (insulin glargine 300 U/mL and insulin degludec) has provided physicians with agents that can provide comparable glycaemic control to first-generation insulin, but with a reduced risk of hypoglycaemia and modes of action suited to once-daily regimens. These characteristics may help overcome patient and physician concerns about early insulin use in disease management. To date, there have been no head-to-head comparisons of second-generation insulins: here we consider recent real-world evidence and the forthcoming direct comparison in the BRIGHT randomised controlled study, as presented at the recent 11 th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2018

Glycaemic control and antidiabetic treatment trends in primary care centres in patients with type 2 diabetes mellitus during 2007-2013 in Catalonia: a population-based study.

OBJECTIVES: To assess trends in prescribing practices of antidiabetic agents and glycaemic control in patients with type 2 diabetes mellitus (T2DM). DESIGN: Cross-sectional analysis using yearly clinical data and antidiabetic treatments prescribed obtained from an electronic population database. SETTING: Primary healthcare centres, including the entire population attended by the Institut Català de la Salut in Catalonia, Spain, from 2007 to 2013. PARTICIPANTS: Patients aged 31-90 years with a diagnosis of T2DM. RESULTS: The number of registered patients with T2DM in the database was 257 072 in 2007, increasing up to 343 969 in 2013. The proportion of patients not pharmacologically treated decreased by 9.7% (95% CI -9.48% to -9.92%), while there was an increase in the percentage of patients on monotherapy (4.4% increase; 95% CI 4.16% to 4.64%), combination therapy (2.8% increase; 95% CI 2.58% to 3.02%), and insulin alone or in combination (increasing 2.5%; 95% CI 2.2% to 2.8%). The use of metformin and dipeptidyl peptidase-IV inhibitors increased gradually, while sulfonylureas, glitazones and α-glucosidase inhibitors decreased. The use of glinides remained stable, and the use of glucagon-like peptide-1 receptor agonists was still marginal. Regarding glycaemic control, there were no relevant differences across years: mean glycated haemoglobin (HbA1c) value was around 7.2%; the percentage of patients reaching an HbA1c≤7% target ranged between 52.2% and 55.6%; and those attaining their individualised target from 72.8% to 75.7%. CONCLUSIONS: Although the proportion of patients under pharmacological treatment increased substantially over time and there was an increase in the use of combination therapies, there have not been relevant changes in glycaemic control during the 2007-2013 period in Catalonia

Differences in the Cardiometabolic Control in Type 2 Diabetes according to Gender and the Presence of Cardiovascular Disease: Results from the eControl Study

The objective of this cross-sectional study was to assess differences in the control and treatment of modifiable cardiovascular risk factors (CVRF: HbA1c, blood pressure [BP], LDL-cholesterol, body mass index, and smoking habit) according to gender and the presence of cardiovascular disease (CVD) in patients with type 2 diabetes mellitus (T2DM) in Catalonia, Spain. The study included available data from electronic medical records for a total of 286,791 patients. After controlling for sex, age, diabetes duration, and treatment received, both men and women with prior CVD had worse cardiometabolic control than patients without previous CVD; women with prior CVD had worse overall control of CVRFs than men except for smoking; and women without prior CVD were only better than men at controlling smoking and BP, with no significant differences in glycemic control. Finally, although the proportion of women treated with lipid-lowering medications was similar to (with prior CVD) or even higher (without CVD) than men, LDL-cholesterol levels were remarkably uncontrolled in both women with and women without CVD. The results stress the need to implement measures to better prevent and treat CVRF in the subgroup of diabetic women, specifically with more intensive statin treatment in those with CVD

How many people with type 2 diabetes fulfil the eligibility criteria for randomized, controlled trials of insulin glargine 300 U/mL in a real-world setting?

Altres ajuts: SanofiRandomized controlled trial (RCT) populations often do not reflect those typically seen in clinical practice. This retrospective, observational cohort study analysed the real-world data of people with type 2 diabetes (T2DM) prescribed basal insulin analogues from electronic medical records (EMRs) in the Explorys database, which includes data from 39 integrated healthcare systems in the United States, to determine how representative selected RCTs investigating insulin glargine 300 U/mL (Gla-300) are of T2DM populations in a real-world setting. Applying eligibility criteria derived from the EDITION 1, 2 and 3 (Gla-300 vs. insulin glargine 100 U/mL [Gla-100]) and BRIGHT (Gla-300 vs. insulin degludec) RCTs, we observed that only 17% (33 345/191 218) of people captured in the real-world database would have been eligible for such trials. Those who were ineligible tended to be older, had more comorbidities and a higher baseline hypoglycaemia rate than the eligible group. Using another large US EMR database (Optum Humedica) as corroboration, we found that 15% (36 285/235 697) would have been eligible to participate in the EDITION/BRIGHT RCTs. Furthermore, only 7% (1734/24 547) would have been eligible for the CONCLUDE (insulin degludec vs. Gla-300) RCT. Our findings remind us of the value of real-world data studies, complementing the results of RCTs, and providing additional insights into groups who would typically be excluded from RCTs

The importance of the initial period of basal insulin titration in people with diabetes

Achieving target glycaemic control is essential in people with diabetes to minimize the risk of long-term complications, and many people with type 2 diabetes will ultimately require basal insulin (BI) therapy to achieve their individualized glycaemic targets. Usually, the first 12 weeks following initiation of BI therapy represents the period when the greatest dose increases and glycaemic reductions occur. Effective glycaemic control combined with minimizing the risk of hypoglycaemia is important to enable the achievement of glycaemic control in the longer term. However, substantial therapeutic inertia exists in clinical practice, both in initiation and up-titration of BI, owing to patient-, physician- and healthcare system-related barriers, including fear of hypoglycaemia and the perception of a burdensome regimen. The more prolonged duration of action, reduced glycaemic variability and lower risk of hypoglycaemia seen with second-generation versus first-generation BI analogues may help alleviate patients' and physicians' concerns and facilitate titration. In turn, optimal BI titration and subsequent metabolic benefits may help improve therapy adherence and self-management. This review details the clinical implications of prompt titration of BI to achieve early glycaemic control, and the importance of minimizing hypoglycaemia risk within the initial titration period. Facilitation of patients' self-management of BI is also addressed

Central de resultats: Revisió de 20 anys d’atenció a la diabetis a Catalunya

Atenció al pacient; Diabetis; CatalunyaAtención al paciente; Diabetes; CataluñaPatient Care; Diabetes; CataloniaCatalunya es troba entre els països de la Unió Europea amb una menor hospitalització per complicacions de la diabetis. Destaca especialment la baixa hospitalització per amputacions. L’any 1993 es va iniciar a Catalunya el primer programa de “Millora Contínua de la Qualitat assistencial (MCQ)” a partir dels indicadors i de les avaluacions periòdiques realitzades pel “Grup d’estudi de la diabetis a l’atenció primària” (GEDAPS). Des de la primera avaluació feta al 1993 s’ha anat observant una progressiva millora en la major part dels indicadors, no només dels de procés assistencial sinó també dels de resultat. Els bons resultats es deuen al lideratge dels professionals de l’atenció primària, l’establiment de les rutes assistencials, la coordinació dels diferents nivells i serveis assistencials, i la implicació dels pacients en el coneixement i control de la malaltia i de l’Administració.Cataluña se encuentra entre los países de la Unión Europea con una menor hospitalización por complicaciones de la diabetes. Destaca especialmente la baja hospitalización por amputaciones. En 1993 se inició en Cataluña el primer programa de "Mejora Continua de la Calidad asistencial (MCQ)" a partir de los indicadores y de las evaluaciones periódicas realizadas por el "Grupo de estudio de la diabetes en la atención primaria" (GEDAPS). Desde la primera evaluación realizada en 1993 ha ido observando una progresiva mejora en la mayor parte de los indicadores, no sólo los de proceso asistencial sino también de los de resultado. Los buenos resultados se deben al liderazgo de los profesionales de la atención primaria, el establecimiento de las rutas asistenciales, la coordinación de los diferentes niveles y servicios asistenciales, y la implicación de los pacientes en el conocimiento y control de la enfermedad y de la Administración

Comorbid autoimmune diseases and burden of diabetes-related complications in patients with type 1 diabetes from a Mediterranean area

AIM: To assess the prevalence of autoimmune diseases (AID) in patients with type 1 diabetes (T1D) and to evaluate whether the rate of diabetes-related complications differs depending on the presence of AID. METHODS: Cross-sectional analysis of 13,570 T1D patients aged ≥ 18 years registered in the SIDIAP database. The association between AID and diabetes-related complications was assessed by multivariable logistic regression models. RESULTS: The prevalence of AID was 18.3% with thyroid AID being the most common. Patients with T1D and AID were more often female and their current age, age of diabetes onset and diabetes duration were higher. Patients with only thyroid AID experienced a lower risk of peripheral artery disease (odds ratio [OR] = 0.51, 95%; confidence interval [CI] 0.31 to 0.81) and kidney disease (OR = 0.68, 95%; 95% CI 0.54 to 0.85), whereas patients with other AID had an increased risk of ischemic heart disease (OR = 1.48, 95%; 95% CI 1.04 to 2.06). CONCLUSIONS: The burden of diabetes-related complications in patients with T1D differs according to the type of additional AID. The presence of diabetes complications is lower in those with autoimmune thyroid disease while the presence of other AID is associated with higher rates of ischemic heart disease

Understanding the physical, social, and emotional experiences of people with uncontrolled Type 2 diabetes: a qualitative study

The purpose of this study was to identify the perceptions, barriers, and facilitators of self-management of Type 2 diabetes mellitus (T2DM) to determine the factors to consider when developing and implementing a person-centered intervention in patients with poor glycemic control attending primary care.CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM) is an initiative included in Plan Nacional de I+D+I and cofinanced by Instituto de Salud Carlos III-Subdireccion General de Evaluación and Fondo Europeo de Desarrollo Regional (FEDER)