- Drug/Regimen
- Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus
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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
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Diabetes Metab J. 2024;48(5):929-936. Published online February 27, 2024
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DOI: https://doi.org/10.4093/dmj.2023.0297
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2,555
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Abstract
PDFSupplementary MaterialPubReader ePub
- 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.
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Citations
Citations to this article as recorded by
- 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
- A Real-World Study of Long-Term Safety and Efficacy of Lobeglitazone in Korean Patients with Type 2 Diabetes Mellitus
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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
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Diabetes Metab J. 2022;46(6):855-865. Published online March 8, 2022
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DOI: https://doi.org/10.4093/dmj.2021.0264
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8,501
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Abstract
PDFPubReader ePub
- 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.
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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
- 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
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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
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Diabetes Metab J. 2022;46(5):689-700. Published online March 17, 2022
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DOI: https://doi.org/10.4093/dmj.2021.0183
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7,056
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Abstract
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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.
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- 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
- γ-Linolenic Acid versus α-Lipoic Acid for Treating Painful
Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority
Trial
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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
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Diabetes Metab J. 2020;44(4):542-554. Published online November 4, 2019
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DOI: https://doi.org/10.4093/dmj.2019.0099
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10,636
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Abstract
PDFSupplementary MaterialPubReader ePub
- 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). MethodsThis 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). ResultsOf 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. ConclusionGLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing
pain intensity measured by the VAS over 12 weeks.
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Umut DALMIŞ, Emine Merve EKİCİ Avrasya Sağlık Bilimleri Dergisi.2024; 7(1): 68. CrossRef - Ranking Alpha Lipoic Acid and Gamma Linolenic Acid in Terms of Efficacy and Safety in the Management of Adults With Diabetic Peripheral Neuropathy: A Systematic Review and Network Meta-analysis
Mario B. Prado, Karen Joy B. Adiao Canadian Journal of Diabetes.2024; 48(4): 233. CrossRef - Comprehensive comparison of a new technology with traditional methods for extracting Ougan (Citrus reticulata cv. Suavissima) seed oils: Physicochemical properties, fatty acids, functional components, and antioxidant activities
Huaxia Yang, Yudan Lin, Xiaoxu Zhu, Haishuo Mu, Yi Li, Shuangyang Chen, Jia Li, Xuedan Cao LWT.2024; 197: 115857. CrossRef - Genetic and Transcriptomic Background of Oxidative Stress and Antioxidative Therapies in Late Complications of Type 2 Diabetes Mellitus: A Systematic Review
Gašper Tonin, Vita Dolžan, Jasna Klen Antioxidants.2024; 13(3): 277. CrossRef - Antinociceptive effects of gamma-linolenic acid in the formalin test in the rats
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Bingyang Liu, Ruiyan Liu, Yi Gu, Xiaoying Shen, Jianqing Zhou, Chun Luo Frontiers in Endocrinology.2024;[Epub] CrossRef - Alpha-lipoic acid activates AMPK to protect against oxidative stress and apoptosis in rats with diabetic peripheral neuropathy
Tianya Zhang, Dong Zhang, Zhihong Zhang, Jiaxin Tian, Jingwen An, Wang Zhang, Ying Ben Hormones.2023; 22(1): 95. CrossRef - Pathogenetic treatments for diabetic peripheral neuropathy
Dan Ziegler Diabetes Research and Clinical Practice.2023; 206: 110764. CrossRef - Omega-3 Nutrition Therapy for the Treatment of Diabetic Sensorimotor
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Deepak Menon, Evan J. H. Lewis, Bruce A. Perkins, Vera Bril Current Diabetes Reviews.2022;[Epub] CrossRef - Effect of Alpha-Lipoic Acid in the Treatment of Diabetic Neuropathy: A Systematic Review
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