Skip to main content
Top
Published in: Advances in Therapy 5/2024

Open Access 21-03-2024 | Hypoglycemia | Original Research

Real-World Outcomes of Individualized Targeted Therapy with Insulin Glargine 300 Units/mL in Insulin-Naïve Korean People with Type 2 Diabetes: TOBE Study

Authors: Eun-Gyoung Hong, Kyung-Wan Min, Jung Soo Lim, Kyu-Jeung Ahn, Chul Woo Ahn, Jae-Myung Yu, Hye Soon Kim, Hyun Jin Kim, Won Kim, Dong Han Kim, Hak Chul Jang

Published in: Advances in Therapy | Issue 5/2024

Login to get access

Abstract

Introduction

The TOujeo BEyond glucose control (TOBE) study evaluated clinical outcomes with insulin glargine 300 units/mL (Gla-300) in insulin-naïve Korean people with type 2 diabetes mellitus (T2DM) in a real-world setting.

Methods

This 24-week, prospective, non-interventional, multicenter, open-label, single-arm, observational study included adults aged ≥ 20 years with T2DM suboptimally controlled with oral hypoglycemic agents and/or glucagon-like peptide 1 receptor agonists who require basal insulin. Eligible participants were assigned to either general target glycated hemoglobin (HbA1c < 7%) or individualized target groups as per physician’s discretion considering guidelines and participants’ characteristics. The primary endpoint was the proportion of participants achieving the HbA1c target (individualized or general) at 24 weeks.

Results

Among 369 participants, 19.5% (72/369) of participants achieved the HbA1c target at week 24; 37.5% (33/88) in the individualized and 13.9% (39/281) in the general target group. In both target groups, similar reductions in fasting plasma glucose and body weight were observed, with low incidence of hypoglycemia, and T2DM duration was significantly shorter in participants who did versus those who did not achieve the target HbA1c (individualized target group: 9.6 ± 8.0 versus 13.1 ± 8.4 years, P = 0.0454; general target group: 10.2 ± 8.6 versus 12.8 ± 7.4 years, P = 0.0378).

Conclusions

This study showed that initiation of insulin therapy with Gla-300 in people with T2DM using an individualized approach is more effective in achieving an HbA1c target. Moreover, earlier initiation of insulin therapy in people with suboptimally controlled T2DM may increase the success rate of glycemic control.
A graphical abstract is available with this article.

Graphical Abstract

Appendix
Available only for authorised users
Literature
4.
go back to reference GBD 2021 Diabetes Collaborators. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;2023(402):203–34. GBD 2021 Diabetes Collaborators. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;2023(402):203–34.
6.
go back to reference Ko SH, Han K, Lee YH, et al. Past and current status of adult type 2 diabetes mellitus management in Korea: a national health insurance service database analysis. Diabetes Metab J. 2018;42:93–100.CrossRefPubMedPubMedCentral Ko SH, Han K, Lee YH, et al. Past and current status of adult type 2 diabetes mellitus management in Korea: a national health insurance service database analysis. Diabetes Metab J. 2018;42:93–100.CrossRefPubMedPubMedCentral
8.
go back to reference Koo BK, Moon MK. Are we in the same risk of diabetes mellitus? Gender- and age-specific epidemiology of diabetes in 2001 to 2014 in the Korean population. Diabetes Metab J. 2016;40:175–81.CrossRefPubMedPubMedCentral Koo BK, Moon MK. Are we in the same risk of diabetes mellitus? Gender- and age-specific epidemiology of diabetes in 2001 to 2014 in the Korean population. Diabetes Metab J. 2016;40:175–81.CrossRefPubMedPubMedCentral
9.
go back to reference Ali SN, Dang-Tan T, Valentine WJ, Hansen BB. Evaluation of the clinical and economic burden of poor glycemic control associated with therapeutic inertia in patients with type 2 diabetes in the United States. Adv Ther. 2020;37:869–82.CrossRefPubMedPubMedCentral Ali SN, Dang-Tan T, Valentine WJ, Hansen BB. Evaluation of the clinical and economic burden of poor glycemic control associated with therapeutic inertia in patients with type 2 diabetes in the United States. Adv Ther. 2020;37:869–82.CrossRefPubMedPubMedCentral
10.
go back to reference Bain SC, Bekker Hansen B, Hunt B, Chubb B, Valentine WJ. Evaluating the burden of poor glycemic control associated with therapeutic inertia in patients with type 2 diabetes in the UK. J Med Econ. 2020;23:98–105.CrossRefPubMed Bain SC, Bekker Hansen B, Hunt B, Chubb B, Valentine WJ. Evaluating the burden of poor glycemic control associated with therapeutic inertia in patients with type 2 diabetes in the UK. J Med Econ. 2020;23:98–105.CrossRefPubMed
11.
go back to reference Goh SY, Ang E, Bajpai S, et al. A patient-centric approach to optimise insulin therapy in Asia. J Diabetes Complications. 2016;30:973–80.CrossRefPubMed Goh SY, Ang E, Bajpai S, et al. A patient-centric approach to optimise insulin therapy in Asia. J Diabetes Complications. 2016;30:973–80.CrossRefPubMed
12.
go back to reference Khunti S, Khunti K, Seidu S. Therapeutic inertia in type 2 diabetes: prevalence, causes, consequences and methods to overcome inertia. Ther Adv Endocrinol Metab. 2019;10:2042018819844694.CrossRefPubMedPubMedCentral Khunti S, Khunti K, Seidu S. Therapeutic inertia in type 2 diabetes: prevalence, causes, consequences and methods to overcome inertia. Ther Adv Endocrinol Metab. 2019;10:2042018819844694.CrossRefPubMedPubMedCentral
13.
go back to reference Maegawa H, Ishigaki Y, Langer J, Saotome-Nakamura A, Andersen M, Japan Diabetes Clinical Data Management (JDDM) Study Group. Clinical inertia in patients with type 2 diabetes treated with oral antidiabetic drugs: results from a Japanese cohort study (JDDM53). J Diabetes Investig. 2021;12:374–81.CrossRefPubMed Maegawa H, Ishigaki Y, Langer J, Saotome-Nakamura A, Andersen M, Japan Diabetes Clinical Data Management (JDDM) Study Group. Clinical inertia in patients with type 2 diabetes treated with oral antidiabetic drugs: results from a Japanese cohort study (JDDM53). J Diabetes Investig. 2021;12:374–81.CrossRefPubMed
14.
go back to reference American Diabetes Association. Standards of medical care in diabetes—2021. Diabetes Care. 2021;44(Suppl 1):S1–2. American Diabetes Association. Standards of medical care in diabetes—2021. Diabetes Care. 2021;44(Suppl 1):S1–2.
15.
16.
go back to reference Lee BW, Kim JH, Ko SH, et al. Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017. Diabetes Metab J. 2017;41:367–73.CrossRefPubMedPubMedCentral Lee BW, Kim JH, Ko SH, et al. Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017. Diabetes Metab J. 2017;41:367–73.CrossRefPubMedPubMedCentral
17.
go back to reference Becker RH, 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. 2015;38:637–43.CrossRefPubMed Becker RH, 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. 2015;38:637–43.CrossRefPubMed
18.
go back to reference 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;43:351–8.CrossRefPubMed 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;43:351–8.CrossRefPubMed
19.
go back to reference 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;22:612–21.CrossRefPubMed 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;22:612–21.CrossRefPubMed
20.
go back to reference 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;20:541–8.CrossRefPubMed 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;20:541–8.CrossRefPubMed
21.
go back to reference Yki-Järvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015;17:1142–9.CrossRefPubMedPubMedCentral Yki-Järvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015;17:1142–9.CrossRefPubMedPubMedCentral
22.
go back to reference Bailey TS, Wu J, Zhou FL, et al. Switching to insulin glargine 300 units/mL in real-world older patients with type 2 diabetes (DELIVER 3). Diabetes Obes Metab. 2019;21:2384–93.CrossRefPubMedPubMedCentral Bailey TS, Wu J, Zhou FL, et al. Switching to insulin glargine 300 units/mL in real-world older patients with type 2 diabetes (DELIVER 3). Diabetes Obes Metab. 2019;21:2384–93.CrossRefPubMedPubMedCentral
23.
go back to reference Ghosh S, Kalra S, Bantwal G, et al. Use of second-generation basal insulin Gla-300 in special populations: a narrative mini-review. Curr Diabetes Rev. 2023;19:86–95.CrossRef Ghosh S, Kalra S, Bantwal G, et al. Use of second-generation basal insulin Gla-300 in special populations: a narrative mini-review. Curr Diabetes Rev. 2023;19:86–95.CrossRef
24.
go back to reference Hassanein M, Buyukbese MA, Malek R, et al. Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: the observational ORION study. Diabetes Res Clin Pract. 2020;166:108189.CrossRefPubMed Hassanein M, Buyukbese MA, Malek R, et al. Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: the observational ORION study. Diabetes Res Clin Pract. 2020;166:108189.CrossRefPubMed
25.
go back to reference Bailey TS, Zhou FL, Gupta RA, et al. Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: real-world results from the DELIVER Naïve cohort study. Diabetes Obes Metab. 2019;21:1596–605.CrossRefPubMedPubMedCentral Bailey TS, Zhou FL, Gupta RA, et al. Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: real-world results from the DELIVER Naïve cohort study. Diabetes Obes Metab. 2019;21:1596–605.CrossRefPubMedPubMedCentral
26.
go back to reference Galstyan GR, Tirosh A, Vargas-Uricoechea H, et al. Real-world effectiveness and safety of insulin glargine 300 u/ml in insulin-naïve people with type 2 diabetes: the ATOS study. Diabetes Ther. 2022;13:1187–202.CrossRefPubMedPubMedCentral Galstyan GR, Tirosh A, Vargas-Uricoechea H, et al. Real-world effectiveness and safety of insulin glargine 300 u/ml in insulin-naïve people with type 2 diabetes: the ATOS study. Diabetes Ther. 2022;13:1187–202.CrossRefPubMedPubMedCentral
27.
go back to reference Kim SS, Kim IJ, Kim YK, et al. Insulin initiation in insulin-naïve Korean type 2 diabetic patients inadequately controlled on oral antidiabetic drugs in real-world practice: the Modality of Insulin Treatment Evaluation Study. Diabetes Metab J. 2015;39:481–8.CrossRefPubMedPubMedCentral Kim SS, Kim IJ, Kim YK, et al. Insulin initiation in insulin-naïve Korean type 2 diabetic patients inadequately controlled on oral antidiabetic drugs in real-world practice: the Modality of Insulin Treatment Evaluation Study. Diabetes Metab J. 2015;39:481–8.CrossRefPubMedPubMedCentral
28.
go back to reference Chon S, Rhee SY, Ahn KJ, et al. Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes: a multicentre randomized trial. Diabetes Obes Metab. 2018;20:1121–30.CrossRefPubMed Chon S, Rhee SY, Ahn KJ, et al. Long-term effects on glycaemic control and β-cell preservation of early intensive treatment in patients with newly diagnosed type 2 diabetes: a multicentre randomized trial. Diabetes Obes Metab. 2018;20:1121–30.CrossRefPubMed
29.
go back to reference UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837–53.CrossRef UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837–53.CrossRef
30.
go back to reference Owens DR, Landgraf W, Frier BM, et al. Commencing insulin glargine 100 U/mL therapy in individuals with type 2 diabetes: determinants of achievement of HbA1c goal less than 7.0. Diabetes Obes Metab. 2019;21:321–9.CrossRefPubMedPubMedCentral Owens DR, Landgraf W, Frier BM, et al. Commencing insulin glargine 100 U/mL therapy in individuals with type 2 diabetes: determinants of achievement of HbA1c goal less than 7.0. Diabetes Obes Metab. 2019;21:321–9.CrossRefPubMedPubMedCentral
31.
go back to reference Terauchi Y, Koyama M, Cheng X, et al. Glycaemic control and hypoglycaemia with insulin glargine 300 U/mL compared with glargine 100 U/mL in Japanese adults with type 2 diabetes using basal insulin plus oral anti-hyperglycaemic drugs (EDITION JP 2 randomised 12-month trial including 6-month extension). Diabetes Metab. 2017;43:446–52.CrossRefPubMed Terauchi Y, Koyama M, Cheng X, et al. Glycaemic control and hypoglycaemia with insulin glargine 300 U/mL compared with glargine 100 U/mL in Japanese adults with type 2 diabetes using basal insulin plus oral anti-hyperglycaemic drugs (EDITION JP 2 randomised 12-month trial including 6-month extension). Diabetes Metab. 2017;43:446–52.CrossRefPubMed
32.
go back to reference Terauchi Y, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016;18:366–74.CrossRefPubMedPubMedCentral Terauchi Y, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016;18:366–74.CrossRefPubMedPubMedCentral
Metadata
Title
Real-World Outcomes of Individualized Targeted Therapy with Insulin Glargine 300 Units/mL in Insulin-Naïve Korean People with Type 2 Diabetes: TOBE Study
Authors
Eun-Gyoung Hong
Kyung-Wan Min
Jung Soo Lim
Kyu-Jeung Ahn
Chul Woo Ahn
Jae-Myung Yu
Hye Soon Kim
Hyun Jin Kim
Won Kim
Dong Han Kim
Hak Chul Jang
Publication date
21-03-2024
Publisher
Springer Healthcare
Published in
Advances in Therapy / Issue 5/2024
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-024-02830-z

Other articles of this Issue 5/2024

Advances in Therapy 5/2024 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.