Ritzel R, et al. – This study was undertaken to evaluate the utility and safety of insulin glargine 300 U/mL (Gla–300) versus insulin glargine 100 U/mL (Gla–100) over 12 months in a patient–level meta–analysis using data from EDITION studies in people with type 2 diabetes (T2DM). The data showed that use of Gla–300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day, versus Gla–100 in a broad population of people with T2DM over 12 months.

Methods

• This was a multicentre, randomised, open–label, two–arm, parallel–group, treat–to–target phase 3a studies.
• Thereafter, similar study designs and endpoints enabled a meta–analysis to be performed.

Results

• The evidence showed that reductions in HbA1c were better sustained over 12 months with Gla–300 than Gla–100 (least squares [LS] mean difference in change from baseline: –0.10 [95% confidence interval (CI): –0.18 to –0.02] % [–1.09 (–2.01 to –0.20) mmol/mol] [p=0.0174]).
• It was noted that risk of confirmed (≤3.9 mmol/L) or severe hypoglycaemia was 15% lower with Gla–300 versus Gla–100 at night (relative risk 0.85 [95% CI: 0.77 to 0.92]) and 6% lower at any time of day (0.94 [0.90 to 0.98]).
• They observed that rates of hypoglycaemia were 18% lower with Gla–300 versus Gla–100 at night (rate ratio 0.82 [0.67 to 0.99]), but comparable at any time of day.
• The evidence suggested that HbA1c The data showed that severe hypoglycaemia was rare; in both treatment groups incidence of events at any time of day was ≤3.6%, while rates were ≤0.08 events per participant–year.