Diabetes & Metabolism Journal

Original Article

Drug/Regimen
A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus: Bo-Yeon Kim, Hyuk-Sang Kwon, Suk Kyeong Kim, Jung-Hyun Noh, Cheol-Young Park, Hyeong-Kyu Park, Kee-Ho Song, Jong Chul Won, Jae Myung Yu, Mi Young Lee, Jae Hyuk Lee, Soo Lim, Sung Wan Chun, In-Kyung Jeong, Choon Hee Chung, Seung Jin Han, Hee-Seok Kim, Ju-Young Min, Sungrae Kim; Diabetes Metab J. 2022;46(6):855-865. Published online March 8, 2022; DOI: https://doi.org/10.4093/dmj.2021.0264

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Background
Thiazolidinediones (TZDs) have been associated with various safety concerns including weight gain, bladder cancer, and congestive heart failure (CHF). This study evaluated the efficacy and safety of lobeglitazone, a novel TZD in patients with type 2 diabetes mellitus (T2DM) in real practice.
Methods
In this non-interventional, multi-center, retrospective, and observational study conducted at 15 tertiary or secondary referral hospitals in Korea, a total of 2,228 patients with T2DM who received lobeglitazone 0.5 mg for more than 1 year were enrolled.
Results
Overall adverse events (AEs) occurred in 381 patients (17.10%) including edema in 1.97% (n=44). Cerebrovascular and cardiovascular diseases were identified in 0.81% (n=18) and 0.81% (n=18), respectively. One case of CHF was reported as an AE. Edema occurred in 1.97% (n=44) of patients. Hypoglycemia occurred in 2.47% (n=55) of patients. Fracture occurred in 1.17% (n=26) of all patients. Lobeglitazone significantly decreased HbA1c level, resulting in a mean treatment difference of -1.05%± 1.35% (P<0.001), and decreased total cholesterol, triglyceride, and low-density lipoprotein cholesterol. However, it increased high-density lipoprotein cholesterol, regardless of statin administration. The patients who received lobeglitazone 0.5 mg showed an apparent reduction in glycosylated hemoglobin (HbA1c) from baseline during the first 6 months of treatment. The HbA1c levels remained stable between months 6 and 42.
Conclusion
Lobeglitazone has long-term safety profile, good glycemic-lowering effect and long-term durability of glycemic control in real-world clinical settings.

Citations

Citations to this article as recorded by

Efficacy and safety of novel thiazolidinedione lobeglitazone for managing type-2 diabetes a meta-analysis
Deep Dutta, Saptarshi Bhattacharya, Manoj Kumar, Priyankar K. Datta, Ritin Mohindra, Meha Sharma
Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102697. CrossRef
Efficacy and safety of lobeglitazone, a new Thiazolidinedione, as compared to the standard of care in type 2 diabetes mellitus: A systematic review and meta-analysis
Shashank R. Joshi, Saibal Das, Suja Xaviar, Shambo Samrat Samajdar, Indranil Saha, Sougata Sarkar, Shatavisa Mukherjee, Santanu Kumar Tripathi, Jyotirmoy Pal, Nandini Chatterjee
Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102703. CrossRef
Will lobeglitazone rival pioglitazone? A systematic review and critical appraisal
Kalyan Kumar Gangopadhyay, Awadhesh Kumar Singh
Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(4): 102747. CrossRef
Lobeglitazone

Reactions Weekly.2023; 1948(1): 262. CrossRef
Lobeglitazone, a novel thiazolidinedione, for secondary prevention in patients with ischemic stroke: a nationwide nested case-control study
Joonsang Yoo, Jimin Jeon, Minyoul Baik, Jinkwon Kim
Cardiovascular Diabetology.2023;[Epub] CrossRef
Lobeglitazone and Its Therapeutic Benefits: A Review
Balamurugan M, Sarumathy S, Robinson R
Cureus.2023;[Epub] CrossRef
Oldies but Goodies: Thiazolidinedione as an Insulin Sensitizer with Cardioprotection
Eun-Hee Cho
Diabetes & Metabolism Journal.2022; 46(6): 827. CrossRef

Response

Response: Efficacy and Safety of Biphasic Insulin Aspart 30/70 in Type 2 Diabetes Suboptimally Controlled on Oral Antidiabetic Therapy in Korea: A Multicenter, Open-Label, Single-Arm Study (Diabetes Metab J 2013;37:117-24): Kee-Ho Song, Jung Min Kim, Jung-Hyun Noh, Yongsoo Park, Hyun-Shik Son, Kyong Wan Min, Kyung Soo Ko; Diabetes Metab J. 2013;37(3):214-215. Published online June 14, 2013; DOI: https://doi.org/10.4093/dmj.2013.37.3.214

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Original Article

Efficacy and Safety of Biphasic Insulin Aspart 30/70 in Type 2 Diabetes Suboptimally Controlled on Oral Antidiabetic Therapy in Korea: A Multicenter, Open-Label, Single-Arm Study: Kee-Ho Song, Jung Min Kim, Jung-Hyun Noh, Yongsoo Park, Hyun-Shik Son, Kyong Wan Min, Kyung Soo Ko; Diabetes Metab J. 2013;37(2):117-124. Published online April 16, 2013; DOI: https://doi.org/10.4093/dmj.2013.37.2.117

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35 Download
5 Crossref

Abstract PDF PubReader

Background

The purpose of this study was to evaluate change in glycosylated hemoglobin (HbA1c), side effects, and quality of life (QOL) after a 16-week treatment period with Biphasic insulin aspart 30/70 (BIasp30) in patients with type 2 diabetes mellitus (T2DM) who had been suboptimally controlled with oral antidiabetic drugs (OADs).

Methods

The study consisted of a 4-week titration period when concurrent OAD(s) were replaced with BIasp30 and followed by a 12-week maintenance period. All patients completed the Diabetes Treatment Satisfaction Questionnaire at the beginning and the end of the trial. Hypoglycemic episodes were recorded by the patient throughout the trial.

Results

Sixty patients were included, of whom 55 patients (92%) completed the full 16-week treatment period. Seven-point blood glucose was significantly improved as compared with the baseline, except for the postlunch blood glucose level. HbA1c at the end of period was significantly improved from 9.2% to 8.2% (P<0.001). Eleven percent (n=6) of patients achieved HbA1c values ≤6.5% and 22% (n=12) of patients achieved <7.0%. There were 3.4 episodes/patients-year of minor hypoglycemia and 0.05 episodes/patients-year of major hypoglycemia. QOL showed significant changes only in the acceptability of high blood glucose category (P=0.003).

Conclusion

Treatment with once or twice daily BIasp30 may be an option for the patients with T2DM suboptimally controlled with OADs in Korea. However, considering the low number of patients achieving the HbA1c target and the high postlunch blood glucose levels, additional management with another modality may be required for optimal control.

Citations

Citations to this article as recorded by

15 Years of Experience with Biphasic Insulin Aspart 30 in Type 2 Diabetes
Andreas Liebl, Viswanathan Mohan, Wenying Yang, Krzysztof Strojek, Sultan Linjawi
Drugs in R&D.2018; 18(1): 27. CrossRef
Basal‐prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24‐week randomized non‐inferiority trial
Sang‐Man Jin, Jae Hyeon Kim, Kyung Wan Min, Ji Hyun Lee, Kue Jeong Ahn, Jeong Hyun Park, Hak Chul Jang, Seok Won Park, Kwan Woo Lee, Kyu Chang Won, Young‐Il Kim, Choon Hee Chung, Tae Sun Park, Jee‐Hyun Lee, Moon‐Kyu Lee
Journal of Diabetes.2016; 8(3): 405. CrossRef
The optimal morning:evening ratio in total dose of twice‐daily biphasic insulin analogue in poorly controlled Type 2 diabetes: a 24‐week multi‐centre prospective, randomized controlled, open‐labelled clinical study
C. H. Jung, J.‐Y. Park, J. H. Cho, K.‐H. Yoon, H. K. Yang, Y.‐H. Lee, B. S. Cha, B.‐W. Lee
Diabetic Medicine.2014; 31(1): 68. CrossRef
Response: Efficacy and Safety of Biphasic Insulin Aspart 30/70 in Type 2 Diabetes Suboptimally Controlled on Oral Antidiabetic Therapy in Korea: A Multicenter, Open-Label, Single-Arm Study (Diabetes Metab J2013;37:117-24)
Kee-Ho Song, Jung Min Kim, Jung-Hyun Noh, Yongsoo Park, Hyun-Shik Son, Kyong Wan Min, Kyung Soo Ko
Diabetes & Metabolism Journal.2013; 37(3): 214. CrossRef
Letter: Efficacy and Safety of Biphasic Insulin Aspart 30/70 in Type 2 Diabetes Suboptimally Controlled on Oral Antidiabetic Therapy in Korea: A Multicenter, Open-Label, Single-Arm Study (Diabetes Metab J2013;37:117-24)
Byung-Wan Lee
Diabetes & Metabolism Journal.2013; 37(3): 212. CrossRef

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