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Background and objective The INSTIGATE study assessed healthcare costs and clinical outcomes in patients with type 2 diabetes mellitus starting insulin therapy in Spain over a 24-month follow up period. Material and methods This was an observational, non-interventional, prospective, multicenter study. Costs incurred in the previous 6 months were assessed at each visit. Results A total of 172 patients with a mean body mass index of 29.6 kg/m 2 , a mean [standard deviation] duration of diabetes of 10.9 [7.0] years and a hemoglobin A 1c value of 9.2% [1.5%] were followed up for at least 12 and up to 24 months. Direct costs were assessed from the perspective of the Spanish healthcare system. Long/intermediate-acting insulin alone was started in 116 patients (67.4%). After 6, 12, and 24 months of insulin treatment, mean [SD] intraindividual changes from baseline in hemoglobin A 1c were −1.9% [1.65%], −1.6 [1.73%], and −1.5% [1.76%] respectively. Mean (median) total diabetes-related healthcare costs per patient increased from €659 (€527) to €1.085 (€694) 6 months after insulin initiation, decreased to €646 (€531) after 12 months, and increased again after 24 months to €667 (€539). Insulin/oral antidiabetics, primary/specialized care, and blood glucose monitoring accounted for 41%, 26%, and 19% of total cost at 24 months respectively. Conclusions Clinical parameters of these patients with type 2 diabetes mellitus improved following insulin initiation. After a temporary increase, direct healthcare costs of diabetes care returned to baseline values at the end of the follow-up period.

Resumen Antecedentes y objetivo El estudio INSTIGATE evalua los costes directos sanitarios y los resultados clinicos en pacientes con diabetes mellitus tipo 2 que inician insulinoterapia en Espana, durante 24 meses. Material y metodo Estudio observacional, no intervencionista, prospectivo y multicentrico. En cada visita se evaluaron los costes incurridos durante los 6 meses previos. Resultados En total se evaluaron 172 pacientes durante al menos 12 o un maximo de 24 meses con un indice de masa corporal medio de 29,6 kg/m 2 , una duracion media [desviacion estandar] de la enfermedad de 10,9 [7,0] anos y un porcentaje de hemoglobina A 1c de 9,2% [1,5%]. Un total de 116 pacientes (67,4%) iniciaron insulina de accion prolongada/intermedia solamente. Los cambios medios intraindividuales en los valores iniciales de hemoglobina A 1c tras 6, 12 y 24 meses de la insulinoterapia fueron, respectivamente, -1,9 [1,65%], -1,6 [1,73%] y -1,5% [1,76%]. La media (mediana) del total de los costes directos sanitarios por paciente aumento de 659 € (527 €) a 1.085 € (694 €) 6 meses despues del inicio de la insulinoterapia, bajo a 646 € (531 €) despues de 12 meses, y 24 meses despues aumento nuevamente a 667 € (539 €). A los 24 meses, los costes de insulina/antidiabeticos orales, medicina general/especializada, y monitorizacion de la glucemia representaron el 41, 26 y 19%, respectivamente, de los costes totales. Conclusiones Los parametros clinicos de estos pacientes con diabetes mellitus tipo 2 mejoraron tras iniciar la insulinoterapia. Tras un incremento temporal, los costes directos sanitarios del tratamiento de la diabetes volvieron a los valores basales al final del periodo de seguimiento.

This study aimed to assess the relative contributions of postprandial and fasting glucose concentrations to overall hyperglycaemia.Patients with type 2 diabetes (n=973) carried out self-monitored blood glucose (SMBG) profiles on entry into the European Exenatide (EUREXA) trial. Glucose area under the curve was calculated for postprandial excursions (AUC(ppg)) and total daytime concentrations6.1 mmol/L (AUC(total)), as well as for the percentage of glycaemia due to postprandial excursions (%(ppg)). In addition, OGTT scores were assessed for each patient. Results were evaluated according to defined HbA(1c) categories.There was a significant linear relationship between HbA(1c) and the derived variables of AUC(ppg), AUC(total) and %(ppg) (P0.001 for each), with explained variance greatest for AUC(total) (r(2)=37.4%). AUC(ppg) increased only slightly up to an HbA(1c) of 7.0%, but showed a steeper increase in higher HbA(1c) categories. Also, the increase in AUC(total) with increasing HbA(1c) was much more pronounced. As a result, the postprandial glucose excursion as a proportion of total glucose (%(ppg)) decreased across HbA(1c) categories from 61.0% at HbA(1c)6.5% to 22.0% at HbA(1c)≥9.0%. HOMA-IR remained virtually unchanged through all HbA(1c) categories, while HOMA-B showed no large changes up to HbA(1c) 7.0%, but then decreased at higher HbA(1c) values. The ΔI30/ΔG30 ratio decreased in the HbA(1c) 7.0-7.9% category, but did not change greatly at higher HbA(1c) categories.With increasing HbA(1c), there was a decrease in the contribution of postprandial hyperglycaemia to total glycaemia, and fasting hyperglycaemia became more important. This is consistent with impaired insulin release, particularly first-phase release, at higher HbA(1c) levels.

 The ‘node-splitting’ model (Dias et al. 2010)  The direct and indirect evidence for each pairwise contrast are split out and compared  Model assesses whether relaxing the consistency constraint improves model fit  The ‘inconsistency’ model (Dias et al. 2010; Dias et al. 2013)  Independent treatment effects, whereby the consistency constraint is relaxed, are estimated for each treatment comparison for which trial evidence is available.  Where trials have more than two treatment arms, independent treatment effects are estimated for the comparisons against a common reference arm rather than for all the possible comparisons within a trial.  This can be compared to the ‘consistency’ model which is the traditional NMA approach assuming consistency between studies in the treatment effects.  The ‘design-by-treatment interaction’ model (Higgins et al. 2012).  ‘design’ refers to the combination of treatments included in a study e.g. estimating the relative treatment effect of A vs B using different designs AB (two arm study comparing A and B) or ABC (3 arm study comparing A, B and C).  The inconsistency between treatment effects using alternative study designs is estimated (Higgins et al. 2012)  These models were applied to the datasets to determine whether inconsistency was present and to examine potential causes. Table 2: Inconsistency results from ‘design-by-treatment’ model (16-36 week add-on to MET ± SU ± TZD) Assessing consistency in a network meta-analysis to compare once weekly dulaglutide versus other GLP-1 receptor agonists in patients with type 2 diabetes

Introduction L’exenatide (EXE) ameliore chez les patients diabetiques de type 2 (DT2), le controle metabolique et reduit le poids corporel (PC). Ces donnees sont issues de l’etude « EURopean EXenAtide » (EUREXA), etude prospective a long terme, en ouvert qui compare les effets de l’EXE versus le Glimepiride (GLIM) sur le maintient du controle glycemique. Un addendum de l’etude EUREXA est de comparer les effets de l’EXE et du GLIM, en ajout a la metformine, sur la composition corporelle et la distribution de la masse grasse, a l’inclusion et apres 9 mois de traitement, dans un sous-groupe de patients. Materiels et Methodes Sur les 1 039 patients randomises, 35 sont entres dans l’addendum et 33 patients DT2 en surpoids (IMC moyen : 32,8 ± 3,98 kg/m2) etaient eligibles. Les patients etaient randomises pour recevoir soit l’EXE (n = 15) soit le GLIM (n = 18). La composition corporelle etait analysee par Impetance Bioelectrique (BIA) et la distribution de la masse grasse abdominale par IRM. Resultats A l’inclusion, les patients avaient un PC de 96,7 (13,55) kg dans le groupe EXE, de 98,0 (10,76) kg dans le groupe GLIM et une HbA1c respectivement de 7,5 % (0,55) et de 7,6 % (0,72) ; les variations moyennes [SEM] d’HbA1c etaient de −0,80 % [0,27] et de −0,71 % [0,24] respectivement (p = 0,796). Les variations du PC etaient de −5,26 [1,03] kg et de +2,14 [0,94] respectivement (p Conclusion EXE et GLIM montrent un controle glycemique comparable apres 9 mois de traitement. Les patients sous GLIM ont augmente leur masse grasse au niveau abdominale. La perte de PC sous EXE chez les patients DT2 en surpoids etait principalement due a une perte de masse grasse abdominale avec aucun changement significatif sur la masse maigre.