Skip to main content

07.02.2024 | Original Article

Effectiveness and safety of insulin glargine U-300 as compared to insulin glargine U-100 in oral antidiabetic (OAD) failure cases—record-based observational study

verfasst von: Shambo S. Samajdar, Shashank R. Joshi, Sougata Sarkar, Santanu K. Tripathi, Satyabrata Sahoo, Nandini Chatterjee, Jyotirmoy Pal, Rutul A. Gokalani

Erschienen in: International Journal of Diabetes in Developing Countries

Einloggen, um Zugang zu erhalten

Abstract

Background

Type 2 diabetes is a significant public health concern that affects over 537 million adults worldwide. Oral antidiabetic (OAD) failure can be a complex management issue in patients with type 2 diabetes. Insulin glargine U-300 is a newer type of basal insulin with more consistent pharmacological effects than traditional insulin glargine.

Objective

This study aimed to assess the safety and effectiveness of insulin glargine U-300 as compared to insulin glargine U-100 in Indian type 2 diabetes patients who had experienced OAD failure.

Methods

This is a record-based observational study conducted on type 2 diabetes patients who had experienced OAD failure.

Results

The study involved 389 cases (189 on insulin glargine U-300 and 200 on insulin glargine U-100). It was found that 56.6% and 58.1% of patients had reduced fasting glucose levels below 130 mg/dl after 1 month of treatment, and 78.8% and 76.1% had a reduction after 3 months following the use of insulin glargine U-300 and insulin glargine U-100, respectively. In patients on glargine U-300 and insulin glargine U-100, the mean fasting plasma glucose decreased from 241.05 ± 65.93 mg/dl at baseline to 142.61 ± 55.19 mg/dl (p < 0.05) and similarly from 250.68 ± 61.41 to 140.27 ± 48.29 mg/dl (p < 0.05) at the end of the first month, respectively. The incidence of hypoglycemia was comparatively fewer in patients using insulin glargine U-300 as compared to those using insulin glargine U-100 (8.1% vs. 6.7%, p < 0.05).

Conclusion

The results suggest that insulin glargine U-300 is an effective and safer treatment option than insulin glargine U-100 for Indian patients with OAD failure. These findings have the potential to improve the management of type 2 diabetes patients with OAD failure globally.
Literatur
1.
Zurück zum Zitat Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th ed. Brussels: International Diabetes Federation; 2021. PMID: 35914061. Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th ed. Brussels: International Diabetes Federation; 2021. PMID: 35914061.
2.
Zurück zum Zitat 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):2669-2701. 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):2669-2701.
3.
Zurück zum Zitat Khunti K, Wolden ML, Thorsted BL, et al. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36(11):3411–7.CrossRefPubMedPubMedCentral Khunti K, Wolden ML, Thorsted BL, et al. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36(11):3411–7.CrossRefPubMedPubMedCentral
4.
Zurück zum Zitat Riddle MC. Insulin therapy in type 2 diabetes mellitus: a practical approach for primary care physicians and other healthcare professionals. J Am Osteopath Assoc. 2013;113(2):152–62. Riddle MC. Insulin therapy in type 2 diabetes mellitus: a practical approach for primary care physicians and other healthcare professionals. J Am Osteopath Assoc. 2013;113(2):152–62.
5.
Zurück zum Zitat Samajdar SS, Mukherjee S, Tripathi SK, Pal J, Joshi SR. Early initiation of insulin therapy in newly diagnosed patients with type 2 diabetes and exploring the legacy effect—a single-arm prospective observational study. Bengal Phys J. 2020;7(3):52–4.CrossRef Samajdar SS, Mukherjee S, Tripathi SK, Pal J, Joshi SR. Early initiation of insulin therapy in newly diagnosed patients with type 2 diabetes and exploring the legacy effect—a single-arm prospective observational study. Bengal Phys J. 2020;7(3):52–4.CrossRef
6.
Zurück zum Zitat Matsuhisa M, Koyama M, Cheng X, et al. Efficacy and safety of insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 2 diabetes inadequately controlled on basal insulin with oral antidiabetic drugs: a randomized, controlled trial (EDITION JP 2). Diabetes Obes Metab. 2018;20(6):1299–307. Matsuhisa M, Koyama M, Cheng X, et al. Efficacy and safety of insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 2 diabetes inadequately controlled on basal insulin with oral antidiabetic drugs: a randomized, controlled trial (EDITION JP 2). Diabetes Obes Metab. 2018;20(6):1299–307.
7.
Zurück zum Zitat Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560–72.CrossRefPubMed Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560–72.CrossRefPubMed
8.
Zurück zum Zitat Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2015;38(12):2217–24.CrossRefPubMed Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2015;38(12):2217–24.CrossRefPubMed
9.
Zurück zum Zitat Yki-Jarvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386–94.CrossRef Yki-Jarvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386–94.CrossRef
10.
Zurück zum Zitat Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37(10):2755–62.CrossRefPubMed Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37(10):2755–62.CrossRefPubMed
11.
Zurück zum Zitat Ritzel R, Roussel R, Bolli GB, Vinet L, Brulle-Wohlhueter C, Glezer S, Yki-Järvinen H. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes Metab. 2015 Sep;17(9):859-67. doi: https://doi.org/10.1111/dom.12485. Epub 2015 Jun 16. PMID: 25929311; PMCID: PMC4676914. Ritzel R, Roussel R, Bolli GB, Vinet L, Brulle-Wohlhueter C, Glezer S, Yki-Järvinen H. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes Metab. 2015 Sep;17(9):859-67. doi: https://​doi.​org/​10.​1111/​dom.​12485. Epub 2015 Jun 16. PMID: 25929311; PMCID: PMC4676914.
13.
14.
15.
Zurück zum Zitat Duque N, Artime E, Romera I, Lebrec J, Díaz S, Rubio M, Sicras-Mainar A, Carretero-Anibarro E, Mundet X, Gorgojo-Martínez JJ, Reviriego J. Real-world use of insulin glargine U100 and U300 in insulin-naïve patients with type 2 diabetes mellitus: DosInGlar study. Advances in Therapy. 2021;38(7):3857–71.CrossRefPubMedPubMedCentral Duque N, Artime E, Romera I, Lebrec J, Díaz S, Rubio M, Sicras-Mainar A, Carretero-Anibarro E, Mundet X, Gorgojo-Martínez JJ, Reviriego J. Real-world use of insulin glargine U100 and U300 in insulin-naïve patients with type 2 diabetes mellitus: DosInGlar study. Advances in Therapy. 2021;38(7):3857–71.CrossRefPubMedPubMedCentral
16.
Zurück zum Zitat Pujante Alarcon P, Rodriguez Escobedo R, Garcia Urruzola F, Ares J, Manjon L, Sanchez Ragnarson C, Cacho L, Delgado E, Menendez Torre EL. Experience after switching from insulin glargine u100 to glargine U300 in patients with type 1 diabetes mellitus. A study after one year of treatment in real life. ENDOCRINOLOGIA DIABETES Y NUTRICION. 2019 Apr 1;66(4):210-6. Pujante Alarcon P, Rodriguez Escobedo R, Garcia Urruzola F, Ares J, Manjon L, Sanchez Ragnarson C, Cacho L, Delgado E, Menendez Torre EL. Experience after switching from insulin glargine u100 to glargine U300 in patients with type 1 diabetes mellitus. A study after one year of treatment in real life. ENDOCRINOLOGIA DIABETES Y NUTRICION. 2019 Apr 1;66(4):210-6.
17.
Zurück zum Zitat 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. Journal of diabetes research. 2018 Oct;2018. 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. Journal of diabetes research. 2018 Oct;2018.
18.
Zurück zum Zitat Joshi SR, Singh G, Marwah A, Mittra S, Suvarna VR, Athalye SN. Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: a systematic literature review and meta-analysis. Diabetes Obes Metab. 2023;25(6):1589–606.CrossRefPubMed Joshi SR, Singh G, Marwah A, Mittra S, Suvarna VR, Athalye SN. Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: a systematic literature review and meta-analysis. Diabetes Obes Metab. 2023;25(6):1589–606.CrossRefPubMed
19.
Zurück zum Zitat Pfohl M, Jornayvaz FR, Fritsche A, Pscherer S, Anderten H, Pegelow K, Seufert J. Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes after failure of oral therapy in a real-world setting. Diabetes, Obesity and Metabolism. 2020;22(5):759–66.CrossRef Pfohl M, Jornayvaz FR, Fritsche A, Pscherer S, Anderten H, Pegelow K, Seufert J. Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes after failure of oral therapy in a real-world setting. Diabetes, Obesity and Metabolism. 2020;22(5):759–66.CrossRef
20.
Zurück zum Zitat Thomann R, Zechmann S, Alexander-David N, Jornayvaz FR. Real-world effectiveness of insulin glargine 300 initiation in Switzerland. Diabetes, Metabolic Syndrome and Obesity. 2020;3:2359–65.CrossRef Thomann R, Zechmann S, Alexander-David N, Jornayvaz FR. Real-world effectiveness of insulin glargine 300 initiation in Switzerland. Diabetes, Metabolic Syndrome and Obesity. 2020;3:2359–65.CrossRef
Metadaten
Titel
Effectiveness and safety of insulin glargine U-300 as compared to insulin glargine U-100 in oral antidiabetic (OAD) failure cases—record-based observational study
verfasst von
Shambo S. Samajdar
Shashank R. Joshi
Sougata Sarkar
Santanu K. Tripathi
Satyabrata Sahoo
Nandini Chatterjee
Jyotirmoy Pal
Rutul A. Gokalani
Publikationsdatum
07.02.2024
Verlag
Springer India
Erschienen in
International Journal of Diabetes in Developing Countries
Print ISSN: 0973-3930
Elektronische ISSN: 1998-3832
DOI
https://doi.org/10.1007/s13410-024-01317-5