- Drug/Regimen
- Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
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Ji Hye Heo, Kyung Ah Han, Jun Hwa Hong, Hyun-Ae Seo, Eun-Gyoung Hong, Jae Myung Yu, Hye Seung Jung, Bong-Soo Cha
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Diabetes Metab J. 2024;48(5):937-948. Published online February 2, 2024
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DOI: https://doi.org/10.4093/dmj.2023.0314
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- Background
This study assessed the efficacy and safety of triple therapy with pioglitazone 15 mg add-on versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and dapagliflozin.
Methods In this multicenter, double-blind, randomized, phase 3 study, patients with T2DM with an inadequate response to treatment with metformin (≥1,000 mg/day) plus dapagliflozin (10 mg/day) were randomized to receive additional pioglitazone 15 mg/day (n=125) or placebo (n=125) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) levels from baseline to week 24 (ClinicalTrials.gov identifier: NCT05101135).
Results At week 24, the adjusted mean change from baseline in HbA1c level compared with placebo was significantly greater with pioglitazone treatment (–0.47%; 95% confidence interval, –0.61 to –0.33; P<0.0001). A greater proportion of patients achieved HbA1c <7% or <6.5% at week 24 with pioglitazone compared to placebo as add-on to 10 mg dapagliflozin and metformin (56.8% vs. 28% for HbA1c <7%, and 23.2% vs. 9.6% for HbA1c <6.5%; P<0.0001 for all). The addition of pioglitazone also significantly improved triglyceride, highdensity lipoprotein cholesterol levels, and homeostatic model assessment of insulin resistance levels, while placebo did not. The incidence of treatment-emergent adverse events was similar between the groups, and the incidence of fluid retention-related side effects by pioglitazone was low (1.5%).
Conclusion Triple therapy with the addition of 15 mg/day of pioglitazone to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with T2DM inadequately controlled with dapagliflozin plus metformin.
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- Ideal Combination of Oral Hypoglycemic Agents for Patients with Type 2 Diabetes Mellitus
Hye Soon Kim Diabetes & Metabolism Journal.2024; 48(5): 882. CrossRef
- Complications
- Deterioration of Sleep Quality According to Glycemic Status
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Myung Haeng Hur, Mi-Kyoung Lee, Kayeon Seong, Jun Hwa Hong
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Diabetes Metab J. 2020;44(5):679-686. Published online April 17, 2020
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DOI: https://doi.org/10.4093/dmj.2019.0125
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Background
Type 2 diabetes mellitus (T2DM) is a progressive disease with multiple complications. The present study aimed to determine the effects of glycemic status on sleep quality in individuals with T2DM, prediabetes, and normal glucose tolerance (NGT).
Methods
A total of 90 participants were categorized into three groups, T2DM (n=30), prediabetes (n=30), and NGT (n=30). Objective sleep quality was measured with the actigraph wrist-worn device over 3 nights and subjective sleep quality was evaluated with a questionnaire.
Results
The duration of diabetes in the T2DM group was 2.23 years and the glycosylated hemoglobin (HbA1c) levels in the T2DM, prediabetes, and NGT groups were 7.83%, 5.80%, and 5.31%, respectively. Sleep efficiency decreased across the T2DM, prediabetes, and NGT groups (86.25%, 87.99%, and 90.22%, respectively; P=0.047). Additionally, HbA1c levels revealed a significant negative correlation with sleep efficiency (r=−0.348, P=0.001). The sleep quality questionnaire results were similar among the three groups.
Conclusion
Although the participants in the present study were not necessarily conscious of their sleep disturbances, deterioration in sleep quality progressed according to glycemic status.
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Citations
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- The interface of depression and diabetes: treatment considerations
Giuseppe Fanelli, Emanuel Raschi, Gaye Hafez, Silke Matura, Carmen Schiweck, Elisabetta Poluzzi, Carlotta Lunghi Translational Psychiatry.2025;[Epub] CrossRef - The association between insomnia (related symptoms) and glycaemic control: a systematic review and meta-analysis
Yiming Chen, Enyu Tong, Yufeng Rao, Evan YW Yu, Maurice Zeegers, Anke Wesselius Journal of Global Health.2025;[Epub] CrossRef - The potential impact of habitual sleep quality on glycaemic control and inflammation: A study on geriatric patients recently diagnosed with type 2 diabetes mellitus (T2DM)
Nadia Hussain, Amal Hussain Ibrahim Al Haddad, Saima Abbass, Zina Alfahl Sleep Medicine: X.2025; 9: 100139. CrossRef - Risk factors of non communicable diseases among recently diagnosed diabetic patients in a tertiary care Hospital
Yusra Amin, Sonia Mushtaq, Rukhsana Farooq Indian Journal of Clinical Anatomy and Physiology.2024; 10(4): 205. CrossRef - Metabolic health tracking using Ultrahuman M1 continuous glucose monitoring platform in non- and pre-diabetic Indians: a multi-armed observational study
Monik Chaudhry, Mohit Kumar, Vatsal Singhal, Bhuvan Srinivasan Scientific Reports.2024;[Epub] CrossRef - Influence of sleep quality and other associated factors on glycemic control among diabetic patients: A hospital-based study
Yusra Amin, Sonia Mushtaq, Rukhsana Taj, Umara Giyas, Sunil Sachadev Indian Journal of Clinical Anatomy and Physiology.2024; 11(1): 32. CrossRef - Interventional effects of Pueraria oral liquid on T2DM rats and metabolomics analysis
Hong-Bo Yang, Jie-Yu Song, Chan Xu, Jin Li, Chan Zhang, Sun Xie, Chun-li Teng Biomedicine & Pharmacotherapy.2024; 175: 116780. CrossRef - Replacing sedentary time with sleep and physical activity: associations with physical function and wellbeing in Type 2 diabetes
Alix Covenant, Thomas Yates, Alex V. Rowlands, Paddy C. Dempsey, Charlotte L. Edwardson, Andrew P. Hall, Melanie J. Davies, Joseph Henson Diabetes Research and Clinical Practice.2024; 217: 111886. CrossRef - Relation between sleep quality and glycemic control among type 2 diabetic patients
Asmaa Ali Elsayed Ali Frontiers of Nursing.2023; 10(1): 115. CrossRef - Heart rate variability in different sleep stages is associated with metabolic function and glycemic control in type 2 diabetes mellitus
Wenquan Cheng, Hongsen Chen, Leirong Tian, Zhimin Ma, Xingran Cui Frontiers in Physiology.2023;[Epub] CrossRef - Association Between Diabetic Retinopathy and Insomnia Risk: A Nationwide Population-Based Study
Yoo Hyun Um, Tae-Won Kim, Jong-Hyun Jeong, Seung-Chul Hong, Ho-Jun Seo, Kyung-Do Han Frontiers in Endocrinology.2022;[Epub] CrossRef - Nutritional Biomarkers and Factors Correlated with Poor Sleep Status among Young Females: A Case-Control Study
Sara AL-Musharaf, Lama AlAjllan, Ghadeer Aljuraiban, Munirah AlSuhaibani, Noura Alafif, Syed Danish Hussain Nutrients.2022; 14(14): 2898. CrossRef - The impact of sleep disorders on microvascular complications in patients with type 2 diabetes (SLEEP T2D): the protocol of a cohort study and feasibility randomised control trial
Christina Antza, Ryan Ottridge, Smitaa Patel, Gemma Slinn, Sarah Tearne, Matthew Nicholls, Brendan Cooper, Asad Ali, Abd A. Tahrani Pilot and Feasibility Studies.2021;[Epub] CrossRef - Early Development of Bidirectional Associations between Sleep Disturbance and Diabetes
Yongin Cho Diabetes & Metabolism Journal.2020; 44(5): 668. CrossRef
- Clinical Care/Education
- Patient Understanding of Hypoglycemia in Tertiary Referral Centers
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Nan Hee Cho, Nam Kyung Kim, Eugene Han, Jun Hwa Hong, Eon Ju Jeon, Jun Sung Moon, Mi Hae Seo, Ji Eun Lee, Hyun-Ae Seo, Mi-Kyung Kim, Hye Soon Kim
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Diabetes Metab J. 2018;42(1):43-52. Published online February 23, 2018
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DOI: https://doi.org/10.4093/dmj.2018.42.1.43
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- Background
Hypoglycemia is an important complication in the treatment of patients with diabetes. We surveyed the insight by patients with diabetes into hypoglycemia, their hypoglycemia avoidance behavior, and their level of worry regarding hypoglycemia. MethodsA survey of patients with diabetes, who had visited seven tertiary referral centers in Daegu or Gyeongsangbuk-do, Korea, between June 2014 and June 2015, was conducted. The survey contained questions about personal history, symptoms, educational experience, self-management, and attitudes about hypoglycemia. ResultsOf 758 participants, 471 (62.1%) had experienced hypoglycemia, and 250 (32.9%) had experienced hypoglycemia at least once in the month immediately preceding the study. Two hundred and forty-two (31.8%) of the participants had received hypoglycemia education at least once, but only 148 (19.4%) knew the exact definition of hypoglycemia. Hypoglycemic symptoms identified by the participants were dizziness (55.0%), sweating (53.8%), and tremor (40.8%). They mostly chose candy (62.1%), chocolate (37.7%), or juice (36.8%) as food for recovering hypoglycemia. Participants who had experienced hypoglycemia had longer duration of diabetes and a higher proportion of insulin usage. The mean scores for hypoglycemia avoidance behavior and worry about hypoglycemia were 21.2±10.71 and 23.38±13.19, respectively. These scores tended to be higher for participants with higher than 8% of glycosylated hemoglobin, insulin use, and experience of emergency room visits. ConclusionMany patients had experienced hypoglycemia and worried about it. We recommend identifying patients that are anxious about hypoglycemia and educating them about what to do when they develop hypoglycemic symptoms, especially those who have a high risk of hypoglycemia.
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Citations
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- Severe Hypoglycemia Increases Dementia Risk and Related Mortality: A Nationwide, Population-based Cohort Study
Eugene Han, Kyung-do Han, Byung-Wan Lee, Eun Seok Kang, Bong-Soo Cha, Seung-Hyun Ko, Yong-ho Lee The Journal of Clinical Endocrinology & Metabolism.2022; 107(5): e1976. CrossRef - Severe hypoglycemia as a preventable risk factor for cardiovascular disease in patients with type 2 diabetes mellitus
Soo-Yeon Choi, Seung-Hyun Ko The Korean Journal of Internal Medicine.2021; 36(2): 263. CrossRef - Severe hypoglycemia and the risk of end stage renal disease in type 2 diabetes
Jae-Seung Yun, Yong-Moon Park, Kyungdo Han, Hyung-Wook Kim, Seon-Ah Cha, Yu-Bae Ahn, Seung-Hyun Ko Scientific Reports.2021;[Epub] CrossRef - Response: Patient Understanding of Hypoglycemia in Tertiary Referral Centers (Diabetes Metab J 2018;42:43-52)
Nan Hee Cho, Hye Soon Kim Diabetes & Metabolism Journal.2018; 42(2): 175. CrossRef - Letter: Patient Understanding of Hypoglycemia in Tertiary Referral Centers (Diabetes Metab J 2018;42:43-52)
Jae-Han Jeon Diabetes & Metabolism Journal.2018; 42(2): 173. CrossRef
- GDF15 Is a Novel Biomarker for Impaired Fasting Glucose
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Jun Hwa Hong, Hyo Kyun Chung, Hye Yoon Park, Kyong-Hye Joung, Ju Hee Lee, Jin Gyu Jung, Koon Soon Kim, Hyun Jin Kim, Bon Jeong Ku, Minho Shong
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Diabetes Metab J. 2014;38(6):472-479. Published online December 15, 2014
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DOI: https://doi.org/10.4093/dmj.2014.38.6.472
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- Background
Growth differentiation factor-15 (GDF15) is a protein that belongs to the transforming growth factor β superfamily. An elevated serum level of GDF15 was found to be associated with type 2 diabetes mellitus (T2DM). T2DM is an inflammatory disease that progresses from normal glucose tolerance (NGT) to impaired fasting glucose (IFG). Hence, we aimed to validate the relationship between GDF15 and IFG. MethodsThe participants were divided into the following three groups: NGT (n=137), IFG (n=29), and T2DM (n=75). The controls and T2DM outpatients visited the hospital for routine health check-ups. We used fasting blood glucose to detect IFG in nondiabetic patients. We checked the body mass index (BMI), C-reactive protein level, metabolic parameters, and fasting serum GDF15 level. ResultsAge, BMI, triglyceride, insulin, glucose, homeostatic model assessment-insulin resistance (HOMA-IR), and GDF15 levels were elevated in the IFG and T2DM groups compared to the NGT group. In the correlation analysis between metabolic parameters and GDF15, age and HOMA-IR had a significant positive correlation with GDF15 levels. GDF15 significantly discriminated between IFG and NGT, independent of age, BMI, and HOMA-IR. The serum levels of GDF15 were more elevated in men than in women. As a biomarker for IFG based on the receiver operating characteristic curve analysis, the cutoff value of GDF15 was 510 pg/mL in males and 400 pg/mL in females. ConclusionGDF15 had a positive correlation with IR independent of age and BMI, and the serum level of GDF15 was increased in the IFG and T2DM groups. GDF15 may be a novel biomarker for detecting IFG in nondiabetic patients.
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