New Insulin Glargine 300 U/mL for the Treatment of Type 1 and Type 2 Diabetes Mellitus

• Published in: Annals of Pharmacotherapy 2015-10, Vol.49 (10), p.1153-1161
• Main Authors: Goldman, Jennifer, White, John R
• Format: Article
• Language: English
• Subjects: Blood Glucose - analysis; Clinical Trials as Topic; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 2 - drug therapy; Dose-Response Relationship, Drug; Glycated Hemoglobin A - analysis; Humans; Hypoglycemia - chemically induced; Hypoglycemic Agents - pharmacokinetics; Hypoglycemic Agents - pharmacology; Hypoglycemic Agents - therapeutic use; Insulin Glargine - pharmacokinetics; Insulin Glargine - pharmacology; Insulin Glargine - therapeutic use
• ISSN: 1060-0280; 1542-6270
• DOI: 10.1177/1060028015597915

Objective: To describe the studies evaluating the efficacy and safety of new insulin glargine 300 U/mL (Gla-300) as a basal insulin in the treatment of type 1 (T1DM) and type 2 (T2DM) diabetes mellitus. Data Sources: A literature search of MEDLINE was conducted (January 2008-June 2015) using the terms U300, Gla-300, and insulin glargine 300 units/mL and supplemented with congress abstracts published in 2014 and 2015. Study Selection and Data Extraction: All English language studies assessing the efficacy and/or safety of Gla-300 were evaluated. Data Synthesis: The efficacy and safety of once-daily Gla-300 has been compared with insulin glargine 100 U/mL (Gla-100) in the EDITION trials, 6 phase-3, multinational, open-label studies in T1DM and T2DM. Across these studies, Gla-300 consistently demonstrated glycemic control comparable to Gla-100; a mean (standard error) change in glycated hemoglobin A1c of −1.02% (0.03) with both Gla-100 (n = 1235) and Gla-300 (n = 1239) was seen in a patient-level meta-analysis. Gla-300 was associated with comparable or reduced nocturnal hypoglycemia compared with Gla-100; the relative risk for nocturnal hypoglycemia with Gla-300 versus Gla-100 was 0.75 (95% CI = 0.68 to 0.83) in a patient-level meta-analysis. There is also some evidence for less weight gain with Gla-300 compared with Gla-100, despite a higher insulin dose. Gla-300 was well tolerated, with the number of adverse events being comparable to that with Gla-100. Conclusions: These results suggest that Gla-300 may have a place as an alternative, long-acting basal insulin for patients with T1DM or T2DM, with the possibility for improved tolerability.