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Safety and efficacy of insulin glargine 300 u/mL compared with other basal insulin therapies in patients with type 2 diabetes mellitus: a network meta-analysis

Freemantle, N et al.

Gla-300 is a basal insulin that was recently approved by the European Commission and the US Food and Drug Administration. Gla-300 is a concentrated formulation of Gla-100; it has a flatter and more prolonged pharmacokinetic and pharmacodynamic profile than Gla-100. In clinical trials with treat-to-target designs, Gla-300 demonstrated comparable HbA1c reduction to Gla-100 but with a lower risk of hypoglycaemia. The reduced risk of hypoglycaemia with Gla-300 has been attributed to the improved pharmacokinetic and pharmacodynamic properties of insulin glargine when given at higher concentrations.

No randomized controlled trials have compared Gla-300 with other available basal insulin formulations. This makes it difficult to establish the role of Gla-300 within current treatment protocols. In the absence of randomized clinical trials, a NMA may help to estimate the comparative effects of multiple interventions using indirect evidence.

In the current study, a comprehensive literature search and NMA was performed to indirectly compare the efficacy and safety of Gla-300 with other available basal insulin formulations in the treatment of type 2 diabetes. A total of 41 studies were included in the NMA; these studies evaluated Gla-300, Gla-100, IDeg, IDet, premixed insulin, and NPH insulin.

Results indicated that the change in HbA1c was comparable between Gla-300 and IDet (difference −0.08), NPH (0.01), IDeg (−0.12) and premixed insulin (0.26).

Change in body weight was comparable between Gla-300 and IDet (0.69), NPH insulin (−0.76) and IDeg (−0.63), but significantly lower compared with premixed insulin (−1.83). For nocturnal hypoglycaemia, Gla-300 was associated with a significantly lower rate versus NPH (risk ratio: 0.18) and premixed insulin (0.36); no significant differences were noted between Gla-300 and IDet (0.52) and IDeg (0.66). For symptomatic hypoglycaemia, no significant differences were observed between Gla-300 and IDet (0.63), and NPH (0.66) and IDeg (0.55).

Based on these findings, the researchers concluded that Gla-300 appears to provide comparable glycaemic control to other available basal insulin formulations, but with a lower risk of nocturnal hypoglycaemia compared with premixed and NPH insulin. However, they noted that while this NMA (performed in the absence of randomized controlled trials directly comparing Gla-300 with other basal insulin formulations) helps to synthesize available information, it is no substitute for head-to-head clinical trials. 

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Developed by Elsevier B.V., supported by an unrestricted educational grant from Novo Nordisk