Insulin glargine 300 U/mL for basal insulin therapy in type 1 and type 2 diabetes mellitus

Abstract

ObjectiveTo review published clinical studies on the efficacy and safety of new insulin glargine 300 units/mL (Gla-300), a new long-acting insulin analog, for the treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM)Materials and methodsData sources comprised primary research articles on Gla-300, including pharmacodynamic, pharmacokinetic, and clinical studies.ResultsIn pharmacodynamic and pharmacokinetic studies, Gla-300 showed a flatter time–action profile and longer duration of action than Gla-100. Noninferiority of Gla-300 versus Gla-100 for lowering of glycated hemoglobin was demonstrated in Phase III clinical studies covering a range of T1DM and T2DM patient populations. Over 6–12 months of follow-up, Gla-300 consistently showed comparable glycemic efficacy with less hypoglycemia vs Gla-100, even during the first 8 weeks of treatment. Although titrated insulin doses were 11%–17% higher with Gla-300 vs Gla-100, changes in body weight were similar or favored Gla-300.ConclusionClinical studies provide evidence that the pharmacodynamic and pharmacokinetic properties of Gla-300 may translate into clinical benefits in both T1DM and T2DM. Gla-300 may provide a new option for people initiating basal insulin, those requiring higher basal insulin doses, those with T1DM, and those who may be at increased risk for hypoglycemia, such as people with chronic kidney disease, the elderly, and those with cardiovascular comorbidities.

Using 2nd generation basal insulins in type 2 diabetes: Costs and savings in a comparative economic analysis in Italy, based on the BRIGHT study

“…Second-generation insulin analogs represent an important progress in the treatment of diabetes. Both Gla-300 and IDeg-100 have been shown to adequately control blood glucose concentration, in different trials and different types of diabetes [15,16,18]. Compared to Gla-100, the gold standard of basal insulin for more than one decade, 2nd generation insulins have shown a more stable and durable biological activity.…”

“…Compared to Gla-100, the gold standard of basal insulin for more than one decade, 2nd generation insulins have shown a more stable and durable biological activity. But more importantly, new basal insulins would reduce the risk of hypoglycaemia more effectively than 1st generation insulins [15,16,18]. Over the last years, clinicians have been very keen to assess any potential difference between the two new insulins in reducing the hypoglycaemic risk.…”

“…In clinical trials and real-world registries, Gla-300 showed a steadier, prolonged pharmacokinetic and pharmacodynamic effect (i.e. with fewer daily fluctuations of glucose levels) than Gla-100 (1st generation basal insulin) [15,16,18].…”

Therapie des Typ-2-Diabetes

“…Pharmakokinetische und pharmakodynamische Studien haben gezeigt, dass Insulin glargin 300 ein flacheres Wirkprofil besitzt, dass die Wirkung etwas länger anhält und die Tag-zu-Tag-Variabilität geringer ist als unter Insulin glargin 100. Die metabolischen Kontrollen waren unter beiden Insulinen vergleichbar, während die Rate nächtlicher Hypoglykämien unter Insulin glargin 300 signifikant niedriger war als unter Insulin glargin 100 [170][171][172].…”

Therapie des Typ-2-Diabetes

“…Pharmakokinetische und pharmakodynamische Studien haben gezeigt, dass Insulin glargin 300 ein flacheres Wirkprofil besitzt, die Wirkung etwas länger anhält und die Tag-zu-Tag-Variabilität geringer ist als unter Insulin glargin 100. Die metabolischen Kontrollen waren unter beiden Insulinen vergleichbar, während die Rate nächtlicher Hypoglykämien unter Insulin glargin 300 signifikant geringer war als unter Insulin glargin 100 [133][134][135].…”