Real-World Analysis of Rapid-Acting Insulin Analog Use and Its Blood Glucose Lowering Effect in Patients with Type 2 Diabetes Mellitus: Results from PASSION Disease Registry in Korea

Abstract

Purpose

Although rapid-acting insulins (RAIs) are used frequently in Korean clinical settings, evidence on their use is limited. This study explores the pattern and clinical effectiveness of the use of RAIs in Korean patients with type 2 diabetes mellitus (T2DM).

Patients and Methods

This non-interventional, observational study enrolled patients (aged >18 years) with T2DM who were prescribed RAIs. The pattern of use and effectiveness of RAI analogs were evaluated over 6 months.

Results

A total of 299/451 patients were analyzed. Approximately 90% (n/N=270/299) of the patients received insulin glulisine, which significantly reduced their levels of glycated hemoglobin (HbA1c: n=270, mean± standard deviation [SD]; −1.16±6.02%, p=0.0017), fasting plasma glucose (n=40; mean±SD: −54.9±90.89 mg/dl, p=0.0005), and post prandial blood glucose (n=35, mean±SD: −89.46± 105.68 mg/dl, p<0.0001) at 6 months, with a corresponding increase in body weight (BW) (n=197, mean±SD:1.45±3.64 kg, p<0.0001). At 6 months, more patients receiving an intensive regimen (basal insulin+≥2 RAI injections/day) had HbA1c <7% than those receiving a non-intensive regimen (basal insulin+1 RAI injection/day) (20.69% vs 7.46%; p=0.0333); the corresponding reduction in HbA1c was also higher in patients receiving the intensive regimen (p<0.0001). About one-fourth patients (n/N=22/95) were switched to the intensive regimen (from 1 to ≥2 RAI injections/day), and only 4.41% (n/N=9/204) of the patients were switched to 1 RAI injection/day. The patients receiving the intensive regimen showed higher levels of HbA1c reductions (mean±SD: −1.27±1.96%) compared with the maintenance group-1 RAI injection/day (mean±SD: −0.72±1.66%) (p=0.0459), without a significant increase in BW and body mass index.

Conclusion

The insulin glulisine intensification regimen showed glycemic target achievement and can be considered a therapeutic tool in the management of T2DM patients.

Keywords:

• glycated hemoglobin
• insulin glulisine
• intensification
• RAI analogs

Abbreviations

AACE, American Association of Clinical Endocrinologists; ADA, American Diabetes Association; ANCOVA, Analysis of covariance; BMI, Body mass index; BW, Body weight; FPG, Fasting plasma glucose; GLP-1 RA, Glucagon-like peptide-1 receptor agonist; HbA1c, Glycated hemoglobin; LOCF, Last observation carried forward; OHAs, Oral hypoglycemic agents; PPG, postprandial plasma glucose; RAIs, Rapid-acting insulins; SAI, Short-acting insulin; T2DM, Type 2 diabetes mellitus; SD, standard deviation.

Data Sharing Statement

Qualified researchers may request access to patient-level data and related documents [including, eg, the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications]. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at https://www.clinicalstudydatarequest.com.

Ethics Approval and Informed Consent

The study protocol was approved by the local institutional review boards and ethics committee.

The study protocol was approved by the local institutional review boards and ethics committee (Supplementary Table 3). The study data were collected after the patients had signed the data release consent form. The study was conducted in accordance with the guiding principles detailed in the 18th World Assembly (Declaration of Helsinki, 1964) and its subsequent amendments, Good Epidemiology Practice guidelines, and national laws and regulations of Korea.

Acknowledgments

The authors would like to thank the study patients, their family, and caregivers who were involved in this study. Editorial support in the preparation of this publication was provided by Sonal More (Tata Consultancy Services Ltd., India) and paid for by Sanofi. Editorial support in the preparation of this publication was also provided by Anahita Gouri and Rohan Mitra of Sanofi, India. The authors, individually and collectively, are responsible for all content and editorial decisions and received no payment from Sanofi directly or indirectly (through a third party) related to the development/presentation of this publication.

Author Contributions

Authors HS Kim, KH Lee, and SJ Yoo have made substantial contributions to the conception and design. HS Kim, JM Yu, HC Jang, EK Choi, JH Park, HS Shon, CH Chung, KG Park, JH Cho and SJ Yoo contributed to the acquisition of data. All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article has been submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

Hye Soon Kim, Jae Myung Yu, Hak Chul Jang, Eui Kwang Choi, Jeong Hyun Park, Ho Sang Shon, Choon Hee Chung, Keun-Gyu Park, Jae Hyoung Cho, and Soon Jib Yoo have no conflicts of interest in this work. Won Kim, Kyoung Hwa Lee, and Jee Hyun Lee are employees of Sanofi Aventis Korea.

Additional information

Funding

The study was funded by Sanofi Aventis Korea Ltd.