Background: Currently no data are available on the real-world effectiveness of the fixed ratio combination of insulin glargine 100 U/ml and lixisenatide (iGlarLixi). This non-interventional study (it was conducted in Hungary) aimed to evaluate its effects on glycaemic control and hypoglycaemia in real-world practice.

Methods: The single-arm, 6-month (with follow-up visits at 3 and 6 months) study included uncontrolled adults with type 2 diabetes (HbA1c>7,5%) treated by oral antidiabetics (OAD) +/- basal insulin. iGlarLixi treatment was started at the time of inclusion.

Results: Of the included 442 participants, 353 were involved in the efficacy analyses. 282 (79.9%) subjects were treated with OADs, while the remaining 71 (20.1%) with basal insulin and OAD(s) before inclusion. The proportion of participants achieving at least 1.0% HbA1c reduction during the observation period was 60.9% (primary endpoint). All glycaemic variables (mean±SD) improved significantly (p<0,001) during follow-up (HbA1c from 8.9±1.3% to 7.4 ±1.0%, fasting blood glucose from 9.0±2.2 mmol/L to 6.9±1.2 mmol/L, and postprandial blood glucose from 11.3±2.3 mmol/L to 8.5±1.5 mmol/L). All changes were clinically and statistically significant. Body weight was also decreased from 90.5±18.0 kg to 88.2±17.8 kg. Only 37 subjects (10.5%) self-reported at least one symptomatic hypoglycaemic episode during the study. There was no severe hypoglycaemic episode being reported. Frequency of gastrointestinal adverse events was low (5 patients, 1.4%).

Conclusion: The first prospective, non-interventional study confirmed several results from the LIXILAN programme in a real-life setting. iGlarLixi significantly improved glycaemic control with low frequency of hypoglycaemia and gastrointestinal adverse events in a heterogenous population of people with type 2 diabetes. Results confirm similar efficacy and safety in routine clinical care than in randomized controlled trials.

Disclosure

J. T. Kis: None. G. Nagy: Employee; Self; Sanofi-Aventis. P. Stella: Employee; Self; Sanofi-Aventis.

Funding

Sanofi

© 2021 by the American Diabetes Association
2021
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.