medwireNews: People with type 2 diabetes and impaired renal function may derive greater benefit from insulin glargine 300 U/mL (Gla‐300) than insulin degludec 100 U/mL (IDeg‐100), a subgroup analysis of the BRIGHT trial suggests.
The multicenter study, which previously found no difference in glycemic control overall between the two treatments, indicates that insulin-naïve individuals with an estimated glomerular filtration rate (eGFR) below 60 mL/min per 1.73 m2 experience greater reductions in glycated hemoglobin (HbA1c) with Gla‐300 than with IDeg-100 without an increased risk for hypoglycemia.
Writing in Diabetes, Obesity and Metabolism, Martin Haluzík (Institute for Clinical and Experimental Medicine, Prague, Czech Republic) and co-authors say: “The differences in outcomes observed in the present subanalysis reflects the importance of studies in special populations where the results are not necessarily similar to those seen in the general [type 2 diabetes] population.”
Specifically, the researchers found that HbA1c levels fell from a mean 8.6% (70 mmol/mol) at baseline to 6.9% (52 mmol/mol) at week 24 among the 47 individuals with an eGFR below 60 mL/min per 1.73 m2 who were randomly assigned to receive Gla-300.
By comparison, HbA1c fell from a mean 8.3% (67 mmol/mol) to 7.3% (56 mmol/mol) among the 49 individuals with impaired renal function who were randomly assigned to receive IDeg-100. This resulted in a significant least squares mean difference in the change from baseline to week 24 of 0.43% in favor of Gla-300.
In addition, there was no significant difference between the two groups in the incidence and annualized rates of anytime (24 h) or nocturnal (00:00–05:59 h) confirmed hypoglycemia (at both <54 mg/dL and ≤70 mg/dL).
This suggests that “the ability to achieve a lower glycaemic target with Gla-300 does not compromise safety,” Haluzík et al remark.
The investigators found no significant difference between the two treatments in the degree of HbA1c reduction among the patients with mild renal impairment (eGFR 60–<90 mL/min per 1.73 m2; n=365) or normal renal function (eGFR ≥90 mL/min per 1.73 m2; n=467), but did find that the individuals with normal renal function experienced significantly less anytime and nocturnal confirmed hypoglycemia (≤70 mg/dL) with Gla‐300 versus IDeg‐100.
Haluzík and co-investigators note that the study participants were not randomized by renal function subgroup at study entry, which “means that baseline characteristics that may have differed between subgroups were not controlled for.”
They conclude that further studies are needed to confirm their findings “and to determine if Gla-300 may allow more effective glycaemic management in this vulnerable population, and if so, to establish the mechanism by which these outcomes differ.”
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