Real-World Use of Insulin Glargine U100 and U300 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: DosInGlar Study.
Cost
Dose
Glycaemic control
Insulin glargine
Real-world evidence
Type 2 diabetes mellitus
U100
U300
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
05
02
2021
accepted:
05
05
2021
pubmed:
31
5
2021
medline:
6
8
2021
entrez:
30
5
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 34052987
doi: 10.1007/s12325-021-01773-z
pii: 10.1007/s12325-021-01773-z
pmc: PMC8280027
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
Insulin Glargine
2ZM8CX04RZ
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
3857-3871Informations de copyright
© 2021. The Author(s).
Références
Fonseca VA. Defining and characterizing the progression of type 2 diabetes. Diabetes Care. 2009;32(Suppl 2):S151–6. https://doi.org/10.2337/dc09-S301 .
doi: 10.2337/dc09-S301
pubmed: 19875543
pmcid: 2811457
Inzucchi SE, Bergenstah RM, Buse JB, et al. 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. 2015;38(1):140–9. https://doi.org/10.2337/dc14-2441 .
doi: 10.2337/dc14-2441
pubmed: 25538310
Davies MJ, D’Alessio DA, Fradkin J, et al. 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):2669–701. https://doi.org/10.2337/dci18-0033 .
doi: 10.2337/dci18-0033
pubmed: 30291106
pmcid: 6245208
Hilgenfeld R, Seipke G, Berchtold H, Owens DR. The evolution of insulin glargine and its continuing contribution to diabetes care. Drugs. 2014;74(8):911–27. https://doi.org/10.1007/s40265-014-0226-4 .
doi: 10.1007/s40265-014-0226-4
pubmed: 24866023
pmcid: 4045187
Hirose T, Chen CC, Ahn KJ, Kiljański 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):805–33. https://doi.org/10.1007/s13300-019-0613-7 .
doi: 10.1007/s13300-019-0613-7
pubmed: 31020538
pmcid: 6531539
Standl E, Owen DR. New long-acting basal insulins: does benefit outweigh cost? Diabetes Care. 2016;39(Suppl 2):S172–9.
doi: 10.2337/dcS15-3011
Davies M, Dahl D, Heise T, Kiljanski J, Mathieu C. Introduction of biosimilar insulins in Europe. Diabet Med. 2017;34(10):1340–53. https://doi.org/10.1111/dme.13400 .
doi: 10.1111/dme.13400
pubmed: 28608570
pmcid: 5637898
Sanofi-Aventis Deutschland GmbH. Toujeo
Linnebjerg H, Lam ECQ, Zhang X, et al. 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. 2017;19(1):33–9. https://doi.org/10.1111/dom.12759 .
doi: 10.1111/dom.12759
pubmed: 27484286
Becker RHA, Dahmen R, Bergmann K, et al. New insulin glargine 300 units∙mL
doi: 10.2337/dc14-0006
pubmed: 25150159
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. https://doi.org/10.1155/2018/2052101 .
doi: 10.1155/2018/2052101
pubmed: 29619381
pmcid: 5830021
Bolli GB, Riddle MC, Bergenstal RM, et al. 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. https://doi.org/10.1111/dom.12438 .
doi: 10.1111/dom.12438
pubmed: 25641260
pmcid: 4409854
Eli Lilly Nederland B.V. Abasaglar summary of product characteristics. 2020. https://www.ema.europa.eu/en/documents/product-information/abasaglar-previously-abasria-epar-product-information_en.pdf . Accessed 5 Oct 2020.
Sanofi-Aventis Deutschland GmbH. Lantus
United States Food and Drug Administration. Real-world evidence. 2020. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence . Accessed 13 July 2020.
Katkade VB, Sanders KN, Zou KH. 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. https://doi.org/10.2147/JMDH.S160029 .
doi: 10.2147/JMDH.S160029
pubmed: 29997436
pmcid: 6033114
Zaccardi F, Davies MJ, 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. https://doi.org/10.1111/dom.13929 .
doi: 10.1111/dom.13929
pubmed: 32250528
Abitbol A, Brown RE, 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. https://doi.org/10.1016/j.jcjd.2019.04.012 .
doi: 10.1016/j.jcjd.2019.04.012
pubmed: 31256905
Gupta S, Wang H, Skolnik N, et al. 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. https://doi.org/10.1007/s12325-017-0651-3 .
doi: 10.1007/s12325-017-0651-3
pubmed: 29313285
pmcid: 5778176
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. 2019. http://www.encepp.eu/encepp/viewResource.htm?id=29236 . Accessed 8 Jun 2020.
Sicras-Mainar A, Enriquez JL, Hernández I, Sicras-Navarro A. Validation and representativeness of the Spanish BIG-PAC database: Integrated computerized medical records for research into epidemiology, medicines and health resource use (real word evidence). Value Health. 2019;22(3):S734.
doi: 10.1016/j.jval.2019.09.1764
Austin SR, Wong YN, Uzzo RG, et al. Why summary comorbidity measures such as the Charlson Comorbidity Index and Elixhauser score work. Med Care. 2015;53(9):e65–72. https://doi.org/10.1097/MLR.0b013e318297429c .
doi: 10.1097/MLR.0b013e318297429c
pubmed: 23703645
pmcid: 3818341
Giorgino F, Benroubi M, Sun JH, Zimmermann AG, 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. https://doi.org/10.2337/dc14-1625 .
doi: 10.2337/dc14-1625
pubmed: 26089386
Ji L, Kang ES, Dong X, et al. 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. 2020;22(4):612–21. https://doi.org/10.1111/dom.13936 .
doi: 10.1111/dom.13936
pubmed: 31797549
Bolli GB, Riddle MC, Bergenstal RM, et al. 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):351–8. https://doi.org/10.1016/j.diabet.2017.04.007 .
doi: 10.1016/j.diabet.2017.04.007
pubmed: 28622950
Ritzel R, Roussel R, Giaccari A, Vora J, Brulle-Wohlhueter C, Yki-Järvinen 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. 2018;20(3):541–8. https://doi.org/10.1111/dom.13105 .
doi: 10.1111/dom.13105
pubmed: 28862801
Base de Datos de medicamentos del Consejo General de Farmacéuticos (Bot PLUS 2.0). 2020. https://botplusweb.portalfarma.com . Accessed 10 June 2020.
DeVries JH, Desouza C, Bellary S, et al. 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):2426–34. https://doi.org/10.1111/dom.13396 .
doi: 10.1111/dom.13396
pubmed: 29862621
pmcid: 6175309
Purnell JQ, Dev RK, Steffes MW, et al. Relationship of family history of type 2 diabetes, hypoglycemia, and autoantibodies to weight gain and lipids with intensive and conventional therapy in the Diabetes Control and Complications Trial. Diabetes. 2003;52(10):2623–9. https://doi.org/10.2337/diabetes.52.10.2623 .
doi: 10.2337/diabetes.52.10.2623
pubmed: 14514648
Khunti K, Gomes MB, Pocock S, et al. Therapeutic inertia in the treatment of hyperglycaemia in patients with type 2 diabetes: a systematic review. Diabetes Obes Metab. 2018;20(2):427–37. https://doi.org/10.1111/dom.13088 .
doi: 10.1111/dom.13088
pubmed: 28834075
Munk NE, Knudsen JS, Pottegård A, et al. Differences between randomized clinical trial participants and real-world empagliflozin users and the changes in their glycated hemoglobin levels. JAMA Netw Open. 2020;3(2):e1920949. https://doi.org/10.1001/jamanetworkopen.2019.20949 .
doi: 10.1001/jamanetworkopen.2019.20949
pubmed: 32031651
Monti S, Grosso B, Todoerti M, Caporali R. Randomized controlled trials and real-world data: differences and similarities to untangle literature data. Rheumatology (Oxford). 2018;57(57 Suppl 7):54–8. https://doi.org/10.1093/rheumatology/key109 .
doi: 10.1093/rheumatology/key109
Houle J, Lauzier-Jobin F, Beaulieu MD, et al. Socioeconomic status and glycemic control in adult patients with type 2 diabetes: a mediation analysis. BMJ Open Diabetes Res Care. 2016;4(1):e000184. https://doi.org/10.1136/bmjdrc-2015-000184 .
doi: 10.1136/bmjdrc-2015-000184
pubmed: 27239316
pmcid: 4873951
Rahman M, Nakamura K, Hasan SMM, Seino K, Mostofa G. Mediators of the association between low socioeconomic status and poor glycemic control among type 2 diabetics in Bangladesh. Sci Rep. 2020;10(1):6690. https://doi.org/10.1038/s41598-020-63253-8 .
doi: 10.1038/s41598-020-63253-8
pubmed: 32317650
pmcid: 7174358
Parajuli J, Saleh F, Thapa N, Ali L. Factors associated with nonadherence to diet and physical activity among Nepalese type 2 diabetes patients; a cross sectional study. BMC Res Notes. 2014;7:758. https://doi.org/10.1186/1756-0500-7-758 .
doi: 10.1186/1756-0500-7-758
pubmed: 25344089
pmcid: 4230343
Kirkman MS, Rowan-Martin MT, Levin R, et al. Determinants of adherence to diabetes medications: findings from a large pharmacy claims database. Diabetes Care. 2015;38(4):604–9. https://doi.org/10.2337/dc14-2098 .
doi: 10.2337/dc14-2098
pubmed: 25573883
pmcid: 4370331
Bartlett VL, Dhruva SS, Shah ND, Ryan P, Ross JS. Feasibility of using real-world data to replicate clinical trial evidence. JAMA Netw Open. 2019;2(10):e1912869. https://doi.org/10.1001/jamanetworkopen.2019.1286 .
doi: 10.1001/jamanetworkopen.2019.1286
pubmed: 31596493
pmcid: 6802419