Real-world evidence on the use of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) in people with suboptimally controlled type 2 diabetes in Romania: a prospective cohort study (STAR.Ro)

Abstract

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.

Use of iGlarLixi for the Management of Type 2 Diabetes in Japanese Clinical Practice: Prior Treatment Subgroup Analysis of the SPARTA Japan Study

“…Several European real-world studies have assessed the use of iGlarLixi in individuals with T2D [19][20][21]. In an Italian, retrospective 6-month study of 675 participants, iGlarLixi reduced mean HbA1c by 0.77% in the overall population, and by 0.92% in participants treated as per the product label [19], which is consistent with the results of the current subanalysis.…”

Effectiveness and Safety of iGlarLixi (Insulin Glargine 100 U/mL Plus Lixisenatide) in Type 2 Diabetes According to the Timing of Daily Administration: Data from the REALI Pooled Analysis

“…A comparable percentage of time over 24 h was spent with blood glucose levels between 70 and 180 mg/dL when iGlar-Lixi was administered pre-breakfast or pre-evening (73% versus 71%, respectively) [25]. Despite our analysis' encouraging effectiveness findings, there was a lower percentage of study participants achieving HbA1c target of \ 7.0% (26.4%) when compared with the percentage of Corresponding to real-life clinical practice, no forced titration of iGlarLixi was followed in the two pooled studies [13,14]. Hence, less stringent titration may explain the lower percentage of participants reaching HbA1c targets in the present pooled analysis compared to the Lix-iLan RCTs.…”

“…The present analysis pooled patient-level data from two 24-week observational studies [13,14] including adults with T2DM inadequately controlled on OADs with or without basal insulin who initiated iGlarLixi upon the treating physician-investigator's decision. In both studies, iGlarLixi (Suliqua Ò , Sanofi, Paris, France) was self-administered subcutaneously once daily within 1 h prior to a meal (preferably the same meal every day) for 24 weeks, using one of the two SoloStar Ò pen injectors.…”

“…Both pooled studies [13,14] were conducted according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines, and were approved by the relevant institutional review boards/ethics committees. This pooled analysis was also performed in accordance with the Helsinki Declaration of 1964 and its later amendments.…”

“…However, in the product label of iGlarLixi, it is stated, without specifying the injection time, that iGlarLixi should be injected once a day within 1 h prior to a meal (or first meal as per US label) [11], preferably before the same meal every day, when the most convenient meal has been chosen [12]. By using pooled data from two real-world, prospective, observational studies [13,14], we sought to evaluate in routine clinical practice the effectiveness and safety of iGlarLixi in individuals with T2DM inadequately controlled on OADs with or without basal insulin, according to its time of administration (i.e. before breakfast, lunch, dinner, or in case the time of the prandial injection was changed during the study period).…”