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Review
. 2017 Jun 30:10:273-284.
doi: 10.2147/DMSO.S131358. eCollection 2017.

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

Ip Tim Lau  1 , Ka Fai Lee  2 , Wing Yee So  3 , Kathryn Tan  4 , Vincent Tok Fai Yeung  5
Affiliations
Review

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

Ip Tim Lau et al. Diabetes Metab Syndr Obes. .

Abstract

Objective: To 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 methods: Data sources comprised primary research articles on Gla-300, including pharmacodynamic, pharmacokinetic, and clinical studies.

Results: In 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.

Conclusion: Clinical 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.

Keywords: diabetes mellitus; insulin glargine; long-acting insulin.

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Conflict of interest statement

Disclosure KT has served on advisory boards and speaker’s bureaus for Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, MSD, Pfizer, Sanofi, and Takeda. The other authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Profile of mean plasma insulin (INS) in a cohort of patients with type I diabetes mellitus after multiple doses of Gla-300 or Gla-100 in steady-state. Notes: Published previously in Becker et al, Diabetes Care, American Diabetes Association, 2015. Copyright and all rights reserved. Material from this publication has been used with the permission of American Diabetes Association. Abbreviations: Gla-100, insulin glargine 100 U/mL; Gla-300, insulin glargine 300 U/mL; INS, insulin; LLOQ, lower limit of quantitation.
See this image and copyright information in PMC

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