Aims: Randomized controlled trials have shown that insulin glargine 300 U/mL (Gla-300) has a more stable and prolonged glucose lowering effect among patients with type 2 diabetes (T2DM) compared to insulin glargine 100 U/mL (Gla-100), resulting in a reduced risk of hypoglycaemia while maintaining a similar efficacy of lowering HbA1c. We aimed to investigate if the effectiveness of Gla-300 is reproducible in real-world settings.
Material and methods: In this retrospective cohort study, data from a large state-mandated health organization were used to identify adult T2DM patients who were previously on insulin and initiated Gla-300 therapy between 6/ 2016 and 12/2017. Changes in HbA1c levels, body weight and insulin dose were calculated from baseline period and over a follow-up period of 180 days. Documented hypoglycaemia events were also explored.
Results: A total of 1797 patients were included in this study with a mean age of 64.2 (SD = ±11.0y), baseline HbA1c was 8.7 ± 1.6% and 42.5% were females. Among all patients with HbA1c measurement during follow-up (n = 1508), HbA1c was significantly reduced by -0.6% (95% CI -0.6,-0.5; P < .001) from baseline, with a significant reduction in body weight (-0.4 kg; P = <.001).Additionally, a significant (P = .04) reduction of 40.5% in patients with hypoglycaemia events was recorded during follow-up period, from 2.1% (n = 37) at the baseline period to 1.2% (n = 22).
Conclusions: This real-world study supports evidence from RCTs regarding the effectiveness of Gla-300 among T2DM patients by improving glycaemic control.
Keywords: basal insulin; glargine‐300; observational study; type 2 diabetes mellitus.
© 2020 The Authors. Endocrinology, Diabetes & Metabolism published by John Wiley & Sons Ltd.