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.
Introduction
The latest Position Statement of the American Diabetes Association/European Association for the Study of Diabetes proposes the use of a fixed-ratio combination (FRC) of a long-acting basal insulin and a glucagon-like peptide-1 receptor agonist as part of treatment intensification. This study aimed to assess the effectiveness of the insulin glargine + lixisenatide (iGlarLixi) FRC on glycaemic control and hypoglycaemia in real-life settings.
Methods
This non-interventional, 26-week study included participants aged 18–80 years with suboptimally controlled type 2 diabetes (T2D) using oral antidiabetics (OADs) ± basal insulin therapy. The primary efficacy endpoint was the proportion of participants who achieved at least a 1% decrease in glycated haemoblobin (HbA1c) level from baseline to week 26.
Results
Of the 441 participants eligible for entry into the study, 353 were included in the efficacy analyses. These individuals were switched from OADs without (282 [79.9%]) or with (71 [20.1%]) insulin-based treatment. A reduction in HbA1c of at least 1.0% (primary endpoint) was achieved by 215 subjects (60.9%). All glycaemic variables (mean ± standard deviation) improved significantly during follow-up (HbA1c, from 8.9 ± 1.31 to 7.4 ± 0.97%; fasting blood glucose, from 9.0 ± 2.18 to 6.9 ± 1.23 mmol/L; postprandial blood glucose, from 11.3 ± 2.33 to 8.5 ± 1.46 mmol/L;
p
< 0.001 for all). Body weight also decreased during follow-up, from 90.5 ± 18.03 to 88.2 ± 17.75 kg (
p
< 0.001). Overall, 41 participants (9.3% of the safety population) self-reported 101 non-severe hypoglycaemic episodes (incidence rate 0.498 events/person-year). There were no severe hypoglycaemic episodes reported. Gastrointestinal adverse events were reported by five participants (1.1% of the safety population). The vast majority (96.6%) of the study population continued iGlarLixi treatment after the final visit.
Conclusion
The results of this non-interventional study confirmed the efficacy results of the randomized controlled trial programme of the iGlarLixi FRC in a real-life setting. iGlarLixi significantly improved glycaemic control in association with a low frequency of hypoglycaemia and gastrointestinal adverse events in a heterogeneous population of participants with T2D suboptimally controlled with OADs ± basal insulin.
Introduction: The EDITION development program confirmed that insulin glargine 300 U/mL (Gla-300) provides comparable glycemic control to insulin glargine 100 U/mL (Gla-100) but with lower hypoglycemia risk. Our study aimed to evaluate the effectiveness of Gla-300 in everyday practice. Methods: This one-arm, non-interventional study included patients with type 2 diabetes who were switched to Gla-300-based basal-bolus therapy (BBT) and followed for 6 months. Indications for switching included inadequate glycemic control and/or hypoglycemic events with the previous regimen. Results: Overall 229 patients were included, with mean age of 60.9 years. All glycemic variables improved between baseline and 6 months significantly (mean ± standard deviation [SD] hemoglobin A1c [HbA1c] from 8.9 ± 1.5% to 7.5 ± 1.1%, fasting blood glucose from 9.5 ± 3.1 mmol/L to 7.0 ± 2.1 mmol/L, postprandial blood glucose from 12.0 ± 3.8 mmol/L to 8.9 ± 2.5 mmol/L). Gla-300 doses were increased and mealtime insulin doses were unchanged. Rates of both non-severe and severe hypoglycemic events decreased significantly compared to pre-study and 6-month follow-up periods. Patients switched because of elevated HbA1c had higher baseline HbA1c and greater decrease in HbA1c paralleled with increase in insulin doses compared to those switched because of hypoglycemia. Conclusions: In day-today practice, switching from human insulin to Gla-300-based BBT resulted in significant improvement in glycemic control and decrease in hypoglycemia risk.
The possible reason for baseline differences between the two groups was that younger and more motivated patients with better glycemic control tended to join the education program. Education was associated with beneficial body mass changes but not with improvement in glycemic status. Improved self-monitoring and physical activity can be documented in the group of educated patients.
Switch to an insulin glargine-based basal-bolus regimen could achieve a significant improvement in the glycaemic control in patients who were inadequately controlled prior to the switch. Orv Hetil. 2018; 159(29): 1201-1207.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.