Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study

Overview

Journal Adv Ther

Date 2021 May 30

PMID 34052987

Authors

Natalia Duque

Esther Artime

Irene Romera

Jeremie Lebrec

Silvia Diaz

Miriam Rubio

Antoni Sicras-Mainar

Enrique Carretero-Anibarro

Xavier Mundet

Juan J Gorgojo-Martinez

Jesus Reviriego

Affiliations

Soon will be listed here.

Abstract

Introduction: In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10-15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice.

Methods: In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively.

Results: The IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively.

Conclusion: In real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs.

References

Fonseca V . Defining and characterizing the progression of type 2 diabetes. Diabetes Care. 2009; 32 Suppl 2:S151-6. PMC: 2811457. DOI: 10.2337/dc09-S301. View

Inzucchi S, Bergenstal R, Buse J, Diamant M, Ferrannini E, Nauck M . Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2014; 38(1):140-9. DOI: 10.2337/dc14-2441. View

Davies M, DAlessio D, Fradkin J, Kernan W, Mathieu C, Mingrone G . Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018; 41(12):2669-2701. PMC: 6245208. DOI: 10.2337/dci18-0033. View

Hilgenfeld R, Seipke G, Berchtold H, Owens D . The evolution of insulin glargine and its continuing contribution to diabetes care. Drugs. 2014; 74(8):911-27. PMC: 4045187. DOI: 10.1007/s40265-014-0226-4. View

Hirose T, Chen C, Ahn K, Kiljanski J . Use of Insulin Glargine 100 U/mL for the Treatment of Type 2 Diabetes Mellitus in East Asians: A Review. Diabetes Ther. 2019; 10(3):805-833. PMC: 6531539. DOI: 10.1007/s13300-019-0613-7. View

Davies M, Dahl D, Heise T, Kiljanski J, Mathieu C . Introduction of biosimilar insulins in Europe. Diabet Med. 2017; 34(10):1340-1353. PMC: 5637898. DOI: 10.1111/dme.13400. View

Linnebjerg H, Lam E, Zhang X, Seger M, Coutant D, Chua L . Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2016; 19(1):33-39. PMC: 5215447. DOI: 10.1111/dom.12759. View

Becker R, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T . New insulin glargine 300 Units · mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units · mL-1. Diabetes Care. 2014; 38(4):637-43. DOI: 10.2337/dc14-0006. View

Vargas-Uricoechea H . Efficacy and Safety of Insulin Glargine 300 U/mL versus 100 U/mL in Diabetes Mellitus: A Comprehensive Review of the Literature. J Diabetes Res. 2018; 2018:2052101. PMC: 5830021. DOI: 10.1155/2018/2052101. View

10.

Bolli G, Riddle M, Bergenstal R, Ziemen M, Sestakauskas K, Goyeau H . New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015; 17(4):386-94. PMC: 4409854. DOI: 10.1111/dom.12438. View

11.

Katkade V, Sanders K, Zou K . Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. J Multidiscip Healthc. 2018; 11:295-304. PMC: 6033114. DOI: 10.2147/JMDH.S160029. View

12.

Zaccardi F, Davies M, Khunti K . The present and future scope of real-world evidence research in diabetes: What questions can and cannot be answered and what might be possible in the future?. Diabetes Obes Metab. 2020; 22 Suppl 3:21-34. DOI: 10.1111/dom.13929. View

13.

Abitbol A, Brown R, Jiandani D, Sauriol L, Aronson R . Real-World Health Outcomes of Insulin Glargine 300 U/mL vs Insulin Glargine 100 U/mL in Adults With Type 1 and Type 2 Diabetes in the Canadian LMC Diabetes Patient Registry: The REALITY Study. Can J Diabetes. 2019; 43(7):504-509.e1. DOI: 10.1016/j.jcjd.2019.04.012. View

14.

Gupta S, Wang H, Skolnik N, Tong L, Liebert R, Lee L . Treatment Dosing Patterns and Clinical Outcomes for Patients with Type 2 Diabetes Starting or Switching to Treatment with Insulin Glargine (300 Units per Milliliter) in a Real-World Setting: A Retrospective Observational Study. Adv Ther. 2018; 35(1):43-55. PMC: 5778176. DOI: 10.1007/s12325-017-0651-3. View

15.

Austin S, Wong Y, Uzzo R, Beck J, Egleston B . Why Summary Comorbidity Measures Such As the Charlson Comorbidity Index and Elixhauser Score Work. Med Care. 2013; 53(9):e65-72. PMC: 3818341. DOI: 10.1097/MLR.0b013e318297429c. View

16.

Giorgino F, Benroubi M, Sun J, Zimmermann A, Pechtner V . Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015; 38(12):2241-9. DOI: 10.2337/dc14-1625. View

17.

Ji L, Kang E, Dong X, Li L, Yuan G, Shang S . Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial. Diabetes Obes Metab. 2019; 22(4):612-621. PMC: 7384042. DOI: 10.1111/dom.13936. View

18.

Bolli G, Riddle M, Bergenstal R, Wardecki M, Goyeau H, Home P . Glycaemic control and hypoglycaemia with insulin glargine 300U/mL versus insulin glargine 100U/mL in insulin-naïve people with type 2 diabetes: 12-month results from the EDITION 3 trial. Diabetes Metab. 2017; 43(4):351-358. DOI: 10.1016/j.diabet.2017.04.007. View

19.

Ritzel R, Roussel R, Giaccari A, Vora J, Brulle-Wohlhueter C, Yki-Jarvinen H . Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes. Diabetes Obes Metab. 2017; 20(3):541-548. PMC: 5836995. DOI: 10.1111/dom.13105. View

20.

DeVries J, Desouza C, Bellary S, Unger J, Hansen O, Zacho J . Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018; 20(10):2426-2434. PMC: 6175309. DOI: 10.1111/dom.13396. View