ObjectivesTo assess the effectiveness and safety of insulin glargine and lixisenatide (iGlarLixi) fixed-ratio combination on a cohort of Romanian adults with type 2 diabetes (T2D).DesignOpen-label, 24-week, prospective cohort study.Setting65 secondary care diabetes centres in Romania.ParticipantsThe study included 901 adults with T2D suboptimally controlled with previous oral antidiabetic drugs (OADs)±basal insulin (BI) who initiated treatment with iGlarLixi upon the decision of the investigator. Major exclusion criteria were iGlarLixi contraindications and refusal to participate. 876 subjects received at least one dose of iGlarLixi (intention-to-treat/safety population).Primary and secondary outcome measuresThe primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 24 in the modified intention-to-treat population (study participants with HbA1c available at baseline and week 24). Secondary efficacy outcomes were percentage of participants reaching HbA1c targets and change in fasting plasma glucose (FPG).ResultsMean baseline HbA1c was 9.2% (SD 1.4) and FPG was 10.8 mmol/L (2.9). Mean HbA1c change was −1.3% (95% CI: −1.4% to −1.2%, p<0.0001) at week 24. HbA1c levels ≤6.5%, <7% and<7.5% at week 24 were achieved by 72 (8.9%), 183 (22.6%) and 342 (42.3%) participants, respectively. Mean FPG change was −3.1 mmol/L (95% CI: −3.3 to −2.8, p<0.001) at week 24. Mean body weight change was −1.6 kg (95% CI: −1.9 to −1.3, p<0.001) at 24 weeks. Mean iGlarLixi dose increased from 19.5 U (SD 7.7) and 30.1 U (10.0) to 30.2 U (8.9) (ratio 2/1 pen) and 45.0 U (11.6) (ratio 3/1 pen). Adverse events (AEs) were reported by 43 (4.9%) participants (18 (2.1%) gastrointestinal) with 4 (0.5%) reporting serious AEs. 13 (1.5%) participants reported at least one event of symptomatic hypoglycaemia, with one episode of severe hypoglycaemia reported.ConclusionsIn a real-world setting, 24-week treatment with iGlarLixi provided a significant reduction of HbA1c with body weight loss and low hypoglycaemia risk in T2D suboptimally controlled with OADs±BI treatment.

The fixed-ratio combination (FRC) of a basal insulin and a GLP-1 receptor agonist (GLP-1 RA) has proven to be an effective therapeutic approach. However, physicians face numerous practical questions that cannot be answered by recently published trial results, current guidelines and summaries of product characteristics. In April 2019, a scientific meeting was held with the participation of nine experts from four Central and Eastern European countries to provide expert consensus on the optimal daily use of the insulin glargine and lixisenatide FRC (iGlarLixi). Topics included the positioning and initiation of iGlarLixi and the management of treatment. This paper summarizes the outcomes of the meeting.

Background Social jetlag (SJL) is a small recurrent circadian rhythm disruption and the most frequent form of circadian rhythm misalignment. The main aim of this study was to investigate the effect of SJL on glycemic control, as assessed by HbA1c, in real‐life settings. Methods In all, 115 consecutive patients with type 1 diabetes (T1D) were analyzed cross‐sectionally. Data on bedtime, sleep onset latency, and wake up time on weekdays and weekends during the previous month were collected from all participants and used to calculate SJL, chronotype, and sleep duration. Sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI). A PSQI score > 5 was considered as an indicator of poor sleep quality. Results Patients with SJL ≥ 1 hour had significantly higher adjusted values of HbA1c than those with SJL <1 hour (8.7% vs 8.0%; P = 0.029). In unadjusted multivariate regression analysis, SJL ≥ 1 hour and poor sleep quality were significant predictors of HbA1c values, explaining 22.7% and 23.5%, respectively, of the increase in HbA1c. After adjusting for age, sex, diabetes duration, insulin dose (kg/d), insulin regimen and body mass index, only SJL ≥ 1 hour remained associated with HbA1c (β = 0.253; P = 0.026). There was no significant interaction between SJL ≥ 1 hour and poor sleep quality in either the unadjusted or adjusted models (Pinteraction = 0.914). Conclusions In patients with T1D, SJL is associated with poor glycemic control, acting independently of sleep quality, sleep duration, and chronotype to exert a deleterious effect on glycemic control.

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