Diabetes & Metabolism Journal

Original Articles

Drug/Regimen
Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus: Shinae Kang, Yu-Bae Ahn, Tae Keun Oh, Won-Young Lee, Sung Wan Chun, Boram Bae, Amine Dahaoui, Jin Sook Jeong, Sungeun Jung, Hak Chul Jang; Diabetes Metab J. 2024;48(5):929-936. Published online February 27, 2024; DOI: https://doi.org/10.4093/dmj.2023.0297

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Background
This study investigated the real-world efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in Korean adults with type 2 diabetes mellitus (T2DM), whose insulin treatment was switched to IDegAsp.
Methods
This was a multicenter, retrospective, observational study comprising two 26-week treatment periods, before and after switching to IDegAsp, respectively. Korean adults with uncontrolled T2DM treated with basal or premix insulin (±oral antidiabetic drugs) were enrolled. The primary objective was to compare the degree of glycosylated hemoglobin (HbA1c) change in each 26-week observation period. The analyses included changes in HbA1c, fasting plasma glucose (FPG), body weight, proportion of participants achieving HbA1c <7.0%, hypoglycemic events, and total daily insulin dose (ClinicalTrials.gov, number NCT04656106).
Results
In total, 196 adults (mean age, 65.95 years; mean T2DM duration, 18.99 years) were analyzed. The change in both HbA1c and FPG were significantly different between the pre-switching and the post-switching period (0.28% vs. –0.51%, P<0.001; 5.21 mg/dL vs. –23.10 mg/dL, P=0.005), respectively. After switching, the rate of achieving HbA1c <7.0% was significantly improved (5.10% at baseline vs. 11.22% with IDegAsp, P=0.012). No significant differences (before vs. after switching) were observed in body weight change, and total daily insulin dose. The rates of overall and severe hypoglycemia were similar in the two periods.
Conclusion
In real-world clinical practice in Korea, the change of insulin regimen to IDegAsp was associated with an improvement in glycemic control without increase of hypoglycemia, supporting the use of IDegAsp for patients with T2DM uncontrolled with basal or premix insulin.

Citations

Citations to this article as recorded by

Switching to insulin degludec/aspart penfill reusable cartridges in patients with type 2 diabetes mellitus: real-life outcomes
Sezin Dogan Çakır, Hatice Deniz Yücel, Zeynep Akgül Kızılçay, Mine Adaş
Diabetology & Metabolic Syndrome.2025;[Epub] CrossRef
Efficacy and safety of insulin degludec/aspart in patients with type 2 and type 1 diabetes mellitus: real-world evidence from Indonesia
Hendra Zufry, Krishna Wardhana Sucipto, Agustia Sukri Ekadamayanti, Qanita Iqbal
Frontiers in Endocrinology.2025;[Epub] CrossRef
Switching from Premixed Insulin to Insulin Degludec/Insulin Aspart for the Management of Type 2 Diabetes Mellitus: Implications of a Real-World Study on Insulin Degludec Dosing
Yiming Wu, Junqing Zhang, Ang Li
Diabetes Therapy.2024; 15(12): 2515. CrossRef

Drug/Regimen
Comparison of Efficacy of Glimepiride, Alogliptin, and Alogliptin-Pioglitazone as the Initial Periods of Therapy in Patients with Poorly Controlled Type 2 Diabetes Mellitus: An Open-Label, Multicenter, Randomized, Controlled Study: Hae Jin Kim, In Kyung Jeong, Kyu Yeon Hur, Soo-Kyung Kim, Jung Hyun Noh, Sung Wan Chun, Eun Seok Kang, Eun-Jung Rhee, Sung Hee Choi; Diabetes Metab J. 2022;46(5):689-700. Published online March 17, 2022; DOI: https://doi.org/10.4093/dmj.2021.0183

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Background
The choice of an optimal oral hypoglycemic agent in the initial treatment periods for type 2 diabetes mellitus (T2DM) patients remains difficult and deliberate. We compared the efficacy and safety of glimepiride (GLIM), alogliptin (ALO), and alogliptin-pioglitazone (ALO-PIO) in poorly controlled T2DM patients with drug-naïve or metformin failure.
Methods
In this three-arm, multicenter, open-label, randomized, controlled trial, poorly controlled T2DM patients were randomized to receive GLIM (n=35), ALO (n=31), or ALO-PIO (n=33) therapy for 24 weeks. The primary endpoint was change in the mean glycosylated hemoglobin (HbA1c) levels at week 24 from baseline. Secondary endpoints were changes in HbA1c level at week 12 from baseline, fasting plasma glucose (FPG) levels, lipid profiles at weeks 12 and 24, and parameters of glycemic variability, assessed by continuous glucose monitoring for 24 weeks.
Results
At weeks 12 and 24, the ALO-PIO group showed significant reduction in HbA1c levels compared to the ALO group (–0.96%±0.17% vs. –0.37%±0.17% at week 12; –1.13%±0.19% vs. –0.18%±0.2% at week 24). The ALO-PIO therapy caused greater reduction in FPG levels and significant increase in high-density lipoprotein cholesterol levels at weeks 12 and 24 than the ALO therapy. Compared to low-dose GLIM therapy, ALO-PIO therapy showed greater improvement in glycemic variability. The adverse events were similar among the three arms.
Conclusion
ALO-PIO combination therapy during the early period exerts better glycemic control than ALO monotherapy and excellency in glycemic variability than low-dose sulfonylurea therapy in uncontrolled, drug-naïve or metformin failed T2DM patients.

Citations

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Assessment of the effectiveness and safety of fixed-dose combination of alogliptin and pioglitazone in real clinical practice: results of the PROsperity study
M. V. Shestakova, M. I. Kharakhulakh, Y. A. Belolipetsky
Diabetes mellitus.2025; 28(2): 198. CrossRef
Fixed-dose combinations of hypoglycemic drugs: potential of alogliptin/pioglitazone in type 2 diabetes mellitus: a review
Olga I. Butranova, Sergey K. Zyryanov, Anna R. Melnikova, Anastasia E. Matsepuro
Terapevticheskii arkhiv.2025; 97(8): 735. CrossRef
Innovative Lipid-Lowering Strategies: RNA-Based, Small Molecule, and Protein-Based Therapies
Youngwoo Jang, Eun-Jung Rhee, Sung Hee Choi
Endocrinology and Metabolism.2025; 40(5): 668. CrossRef
A Comprehensive Review on Weight Loss Associated with Anti-Diabetic Medications
Fatma Haddad, Ghadeer Dokmak, Maryam Bader, Rafik Karaman
Life.2023; 13(4): 1012. CrossRef
Role of Dipeptidyl Peptidase 4 Inhibitors in Antidiabetic Treatment
Ruili Yin, Yongsong Xu, Xin Wang, Longyan Yang, Dong Zhao
Molecules.2022; 27(10): 3055. CrossRef

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

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Lobeglitazone improves glycaemic control as add‐on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double‐blind, randomised, placebo‐controlled trial
Da Hea Seo, Kyung Wan Min, Ho Sang Sohn, Sang Yong Kim, In‐Kyung Jeong, Cheol‐Young Park, Kun‐Ho Yoon, So Hun Kim, Bong‐Soo Cha
Diabetes, Obesity and Metabolism.2026; 28(1): 728. CrossRef
Insights into the Chemistry, Pharmacokinetics and Analytical Techniques of Lobeglitazone: A Novel Anti-diabetic Drug
Saradhkumar Mudaliar, Nandan Godani, Sanjay Sharma
Current Analytical Chemistry.2026; 22(2): 185. CrossRef
Anti-diabetic Drugs and Cancer: Integrated Mechanisms of Tumor Suppression and Clinical Translation
Mahya Asadalizadeh, Mohammad Kazem Molavi Rahbar, Tabassom Mahmoudie, Mahshid Abbasi, Mitra Akbari, Davoud Shakiba, Aida Mohammadiun Shabestari, Meysam Ebrahimifar
Indian Journal of Clinical Biochemistry.2026;[Epub] CrossRef
Effects of Long-Term Lobeglitazone Treatment on Renal Function and Albuminuria in Korean Patients with Type 2 Diabetes Mellitus: A Multicenter Retrospective Observational Study (LUCKY)
Hee-Sung Kim, Chang Hee Jung, Jung-Hyun Noh, Eun-Jung Rhee, Heung-Yong Jin, In-Kyung Jeong
Diabetes Therapy.2026;[Epub] CrossRef
The Many Facets of PPAR-γ Agonism in Obesity and Associated Comorbidities: Benefits, Risks, Challenges, and Future Directions
Dimitris Kounatidis, Natalia G. Vallianou, Eleni Rebelos, Marina Kouveletsou, Paraskevi Kontrafouri, Ioanna Eleftheriadou, Evanthia Diakoumopoulou, Irene Karampela, Nikolaos Tentolouris, Maria Dalamaga
Current Obesity Reports.2025;[Epub] CrossRef
Characterization of Forced Degradation Products of Lobeglitazone Sulfate by Liquid Chromatography–Tandem Mass Spectrometry and In Silico Toxicity Study—Development and Validation of Stability‐Indicating Reverse Phase Liquid Chromatographic Method
Chandrakant Bonde, Hemant Kumar Tatapudi, Ritik Nikam, Smita Bonde, Ritesh Bhole
SEPARATION SCIENCE PLUS.2025;[Epub] CrossRef
Efficacy and safety of lobeglitazone added to metformin and sitagliptin combination therapy in patients with type 2 diabetes: A 52‐week, multicentre, randomized, placebo‐controlled, phase III clinical trial
Eun‐Gyoung Hong, Kyung‐Wan Min, SungWan Chun, Choon Hee Chung, Seungjoon Oh, Chang Beom Lee, Dong‐Jun Kim, Hye Soon Kim, Ji Oh Mok, Tae Seo Sohn, Jeong Hyun Park, Sung Hee Choi, Sungrae Kim, Sang Soo Kim, Kyu Yeon Hur, Chong Hwa Kim, Young Min Cho, Byung‐
Diabetes, Obesity and Metabolism.2025; 27(10): 5727. CrossRef
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

Drug/Regimen
γ-Linolenic Acid versus α-Lipoic Acid for Treating Painful Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority Trial: Jong Chul Won, Hyuk-Sang Kwon, Seong-Su Moon, Sung Wan Chun, Chong Hwa Kim, Ie Byung Park, In Joo Kim, Jihyun Lee, Bong Yun Cha, Tae Sun Park; Diabetes Metab J. 2020;44(4):542-554. Published online November 4, 2019; DOI: https://doi.org/10.4093/dmj.2019.0099

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Background

This study was a multicenter, parallel-group, double-blind, double-dummy, randomized, noninferiority trial to evaluate the efficacy and safety of γ-linolenic acid (GLA) relative to α-lipoic acid (ALA) over a 12-week treatment period in type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN).

Methods

This study included 100 T2DM patients between 20 and 75 years of age who had painful DPN and received either GLA (320 mg/day) and placebo or ALA (600 mg/day) and placebo for 12 weeks. The primary outcome measures were mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS).

Results

Of the 100 subjects who initially participated in the study, 73 completed the 12-week treatment period. Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups. The treatment difference for the VAS (95% confidence interval [CI]) between the two groups was −0.65 (−1.526 to 0.213) and the upper bound of the 95% CI did not exceed the predefined noninferiority margin (δ₁=0.51). For the TSS, the treatment difference was −0.05 (−1.211 to 1.101) but the upper bound of the 95% CI crossed the noninferiority margin (δ₂=0.054). There were no serious adverse events associated with the treatments.

Conclusion

GLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing pain intensity measured by the VAS over 12 weeks.

Citations

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Protective Effects of Lithospermic Acid B on Diabetic Nephropathy in OLETF Rats Comparing with Amlodipine and Losartan.: Eun Seok Kang, Beom Seok Kim, Chul Hoon Kim, Gi Ho Seo, Seung Jin Han, Sung Wan Chun, Kyu Yeon Hur, Chul Woo Ahn, Hunjoo Ha, Mankil Jung, Bong Soo Cha, Hyun Chul Lee; Korean Diabetes J. 2008;32(1):10-20. Published online February 1, 2008; DOI: https://doi.org/10.4093/kdj.2008.32.1.10

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Abstract PDF

BACKGROUND
Lithospermic acid B (LAB), an active component isolated from Salvia miltiorrhizae, has been reported to have renoprotective effects in type 1 and type 2 diabetic animal models. We examined the effects of LAB on the prevention of diabetic nephropathy compared with amlodipine, a calcium channel blocker, and losartan, an angiotensin receptor blocker, in Otsuka Long-Evans-Tokushima Fatty (OLETF) rats, an animal model of type 2 diabetes. METHODS: LAB (20 mg/kg), amlodipine (10 mg/kg), or losartan (10 mg/kg) was given orally once daily to 10-week-old male OLETF rats for 28 weeks. RESULTS: None of LAB, losartan, and amlodipine exhibited effects on blood glucose levels. Treatment with amlodipine or losartan resulted in similar reductions in blood pressure; however, LAB was less effective in lowering blood pressure. Albuminuria was markedly suppressed by losartan and LAB, but not by amlodipine. LAB treatment decreased levels of renal lipid peroxidation, monocyte chemoattractant protein-1 (MCP-1), and transforming growth factor-beta1 (TGF-beta1). CONCLUSION: These results suggest that LAB has beneficial effects on the diabetic nephropathy in OLETF rats by decreasing oxidative stress and inflammation as potent as losartan.

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An Overview on Naturally Occurring Phytoconstituent: Lithospermic Acid
Bhupesh Chander Semwal, Amjad Hussain, Sonia Singh
The Natural Products Journal.2024;[Epub] CrossRef

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