Browsing by Author "Lalic, Nebojsa (13702597500)"
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Publication Advancing therapy in suboptimally controlled basal insulin–treated type 2 diabetes: Clinical outcomes with iglarlixi versus premix biasp 30 in the solimix randomized controlled trial(2021) ;Rosenstock, Julio (7006091173) ;Emral, Rifat (6603414622) ;Sauque-Reyna, Leobardo (6505644318) ;Mohan, Viswanathan (57216603627) ;Trescolı, Carlos (7801372356) ;Al Sifri, Saud (56085622300) ;Lalic, Nebojsa (13702597500) ;Alvarez, Agustina (57223047397) ;Picard, Pascaline (57209307089) ;Bonnemaire, Mireille (6507073079) ;Demil, Nacima (26325264700)McCrimmon, Rory J. (6701669267)OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlar- Lixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin–treated type 2 diabetes (HbA1c ‡7.5% and ©10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: After 26 weeks, baseline HbA1c (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference -0.2% [97.5% CI -0.4, -0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference -1.9 kg [95% CI -2.3, -1.4]) and percentage of participants achieving HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. © 2021 by the American Diabetes Association. - Some of the metrics are blocked by yourconsent settings
Publication Advancing therapy in suboptimally controlled basal insulin–treated type 2 diabetes: Clinical outcomes with iglarlixi versus premix biasp 30 in the solimix randomized controlled trial(2021) ;Rosenstock, Julio (7006091173) ;Emral, Rifat (6603414622) ;Sauque-Reyna, Leobardo (6505644318) ;Mohan, Viswanathan (57216603627) ;Trescolı, Carlos (7801372356) ;Al Sifri, Saud (56085622300) ;Lalic, Nebojsa (13702597500) ;Alvarez, Agustina (57223047397) ;Picard, Pascaline (57209307089) ;Bonnemaire, Mireille (6507073079) ;Demil, Nacima (26325264700)McCrimmon, Rory J. (6701669267)OBJECTIVE: To directly compare the efficacy and safety of a fixed-ratio combination, of insulin glargine 100 units/mL and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlar- Lixi), with those of a premix insulin analog, biphasic aspart insulin 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS: In SoliMix, a 26-week, open-label, multicenter study, adults with suboptimally controlled basal insulin–treated type 2 diabetes (HbA1c ‡7.5% and ©10%) were randomized to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy end points were noninferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30. RESULTS: Both primary efficacy end points were met: After 26 weeks, baseline HbA1c (8.6%) was reduced by 1.3% with iGlarLixi and 1.1% with BIAsp 30, meeting noninferiority (least squares [LS] mean difference -0.2% [97.5% CI -0.4, -0.1]; P < 0.001). iGlarLixi was also superior to BIAsp 30 for body weight change (LS mean difference -1.9 kg [95% CI -2.3, -1.4]) and percentage of participants achieving HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycemia (all P < 0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (P < 0.001). Incidence and rates of American Diabetes Association level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30. CONCLUSIONS: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy. © 2021 by the American Diabetes Association. - Some of the metrics are blocked by yourconsent settings
Publication Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial(2021) ;McCrimmon, Rory J. (6701669267) ;Al Sifri, Saud (56085622300) ;Emral, Rifat (6603414622) ;Mohan, Viswanathan (57216603627) ;Sauque-Reyna, Leobardo (6505644318) ;Trescolí, Carlos (7801372356) ;Lalic, Nebojsa (13702597500) ;Alvarez, Agustina (57223047397) ;Demil, Nacima (26325264700) ;Coudert, Mathieu (59871555800) ;Shaunik, Alka (57219515146) ;Bonnemaire, Mireille (6507073079)Rosenstock, Julio (7006091173)Aim: Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulin glargine 100 units/mL (iGlar) and the GLP-1 RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomized controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue biphasic insulin aspart 30 (BIAsp 30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. Materials and Methods: This was an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomized to switch to either iGlarLixi once daily, or BIAsp 30 twice daily, for 26 weeks. Results: Overall, 887 participants were enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D of 10 years or longer, and the mean HbA1c at baseline was 8.6%. Conclusions: The study directly compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with T2D uncontrolled on basal insulin and one or more oral antihyperglycaemic agents. These results provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy. © 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. - Some of the metrics are blocked by yourconsent settings
Publication Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial(2021) ;McCrimmon, Rory J. (6701669267) ;Al Sifri, Saud (56085622300) ;Emral, Rifat (6603414622) ;Mohan, Viswanathan (57216603627) ;Sauque-Reyna, Leobardo (6505644318) ;Trescolí, Carlos (7801372356) ;Lalic, Nebojsa (13702597500) ;Alvarez, Agustina (57223047397) ;Demil, Nacima (26325264700) ;Coudert, Mathieu (59871555800) ;Shaunik, Alka (57219515146) ;Bonnemaire, Mireille (6507073079)Rosenstock, Julio (7006091173)Aim: Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulin glargine 100 units/mL (iGlar) and the GLP-1 RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomized controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue biphasic insulin aspart 30 (BIAsp 30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. Materials and Methods: This was an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomized to switch to either iGlarLixi once daily, or BIAsp 30 twice daily, for 26 weeks. Results: Overall, 887 participants were enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D of 10 years or longer, and the mean HbA1c at baseline was 8.6%. Conclusions: The study directly compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with T2D uncontrolled on basal insulin and one or more oral antihyperglycaemic agents. These results provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy. © 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. - Some of the metrics are blocked by yourconsent settings
Publication Atypical Leber Hereditary Optic Neuropathy (LHON) Associated with a Novel MT-CYB:m.15309T>C(Ile188Thr) Variant(2025) ;Petrovic Pajic, Sanja (57211992098) ;Fakin, Ana (54925831800) ;Jarc-Vidmar, Martina (6507563069) ;Sustar Habjan, Maja (22986896000) ;Malinar, Lucija (58295629300) ;Pavlovic, Kasja (57224785374) ;Krako Jakovljevic, Nina (55909829900) ;Isakovic, Andjelka (54779767000) ;Misirlic-Dencic, Sonja (13405088600) ;Volk, Marija (15835980500) ;Maver, Ales (22135394900) ;Jezernik, Gregor (57200762116) ;Glavac, Damjan (7003792509) ;Peterlin, Borut (55816646000) ;Markovic, Ivanka (7004033826) ;Lalic, Nebojsa (13702597500)Hawlina, Marko (6603582006)Background: The study presents a detailed examination and follow-up of a Slovenian patient with an Leber Hereditary Optic Neuropathy (LHON)-like phenotype and bilateral optic neuropathy in whom genetic analysis identified a novel variant MT-CYB:m.15309T>C (Ile188Thr). Methods: We provide detailed analysis of the clinical examinations of a male patient with bilateral optic neuropathy from the acute stage to 8 years of follow-up. Complete ophthalmological exam, electrophysiology and optical coherence tomography (OCT) segmentation were performed. The genotype analysis was performed with a complete screening of the mitochondrial genome. Furthermore, proteomic analysis of the protein structure and function was performed to assess the pathogenicity of a novel variant of unknown significance. Mitochondrial function analysis of the patient’s peripheral blood mononuclear cells (PBMCs) was performed with the objective of evaluating the mutation effect on mitochondrial function using flow cytometry and high-resolution respirometry. Results: The patient had a profound consecutive bilateral visual loss at 19 years of age due to optic neuropathy with characteristics of LHON; however, unlike patients with typical LHON, the patient experienced a fluctuation in visual function and significant late recovery. He had a total of three visual acuity deteriorations and improvements in the left eye, with concomitant visual loss in the right eye and a final visual acuity drop reaching nadir 9 months after onset. The visual loss was characterized by centrocecal scotoma, abnormal color vision and abnormal VEP, while deterioration of PERG N95 followed with a lag of several months. The OCT examination showed retinal nerve fiber layer thinning matching disease progression. Following a two-year period of legal blindness, the patient’s visual function started to improve, and over the course of 5 years, it reached 0.5 and 0.7 Snellen (0.3 and 0.15 LogMAR) visual acuity (VA). Mitochondrial sequencing identified a presumably pathogenic variant m.15309T>C in the MT-CYB gene at 65% heteroplasmy, belonging to haplogroup K. Mitochondrial function assessment of the patient’s PBMCs showed a lower respiration rate, an increase in reactive oxygen species production and the presence of mitochondrial depolarization, compared to an age- and sex-matched healthy control’s PBMCs. Conclusions: A novel variant in the MT-CYB:m.15309T>C (Ile188Thr) gene was identified in a patient with optic nerve damage and the LHON phenotype without any additional systemic features and atypical presentation of the disease with late onset of visual function recovery. The pathogenicity of the variant is supported by proteomic analysis and the mitochondrial dysfunction observed in the patient’s PBMCs. © 2025 by the authors. - Some of the metrics are blocked by yourconsent settings
Publication Atypical Leber Hereditary Optic Neuropathy (LHON) Associated with a Novel MT-CYB:m.15309T>C(Ile188Thr) Variant(2025) ;Petrovic Pajic, Sanja (57211992098) ;Fakin, Ana (54925831800) ;Jarc-Vidmar, Martina (6507563069) ;Sustar Habjan, Maja (22986896000) ;Malinar, Lucija (58295629300) ;Pavlovic, Kasja (57224785374) ;Krako Jakovljevic, Nina (55909829900) ;Isakovic, Andjelka (54779767000) ;Misirlic-Dencic, Sonja (13405088600) ;Volk, Marija (15835980500) ;Maver, Ales (22135394900) ;Jezernik, Gregor (57200762116) ;Glavac, Damjan (7003792509) ;Peterlin, Borut (55816646000) ;Markovic, Ivanka (7004033826) ;Lalic, Nebojsa (13702597500)Hawlina, Marko (6603582006)Background: The study presents a detailed examination and follow-up of a Slovenian patient with an Leber Hereditary Optic Neuropathy (LHON)-like phenotype and bilateral optic neuropathy in whom genetic analysis identified a novel variant MT-CYB:m.15309T>C (Ile188Thr). Methods: We provide detailed analysis of the clinical examinations of a male patient with bilateral optic neuropathy from the acute stage to 8 years of follow-up. Complete ophthalmological exam, electrophysiology and optical coherence tomography (OCT) segmentation were performed. The genotype analysis was performed with a complete screening of the mitochondrial genome. Furthermore, proteomic analysis of the protein structure and function was performed to assess the pathogenicity of a novel variant of unknown significance. Mitochondrial function analysis of the patient’s peripheral blood mononuclear cells (PBMCs) was performed with the objective of evaluating the mutation effect on mitochondrial function using flow cytometry and high-resolution respirometry. Results: The patient had a profound consecutive bilateral visual loss at 19 years of age due to optic neuropathy with characteristics of LHON; however, unlike patients with typical LHON, the patient experienced a fluctuation in visual function and significant late recovery. He had a total of three visual acuity deteriorations and improvements in the left eye, with concomitant visual loss in the right eye and a final visual acuity drop reaching nadir 9 months after onset. The visual loss was characterized by centrocecal scotoma, abnormal color vision and abnormal VEP, while deterioration of PERG N95 followed with a lag of several months. The OCT examination showed retinal nerve fiber layer thinning matching disease progression. Following a two-year period of legal blindness, the patient’s visual function started to improve, and over the course of 5 years, it reached 0.5 and 0.7 Snellen (0.3 and 0.15 LogMAR) visual acuity (VA). Mitochondrial sequencing identified a presumably pathogenic variant m.15309T>C in the MT-CYB gene at 65% heteroplasmy, belonging to haplogroup K. Mitochondrial function assessment of the patient’s PBMCs showed a lower respiration rate, an increase in reactive oxygen species production and the presence of mitochondrial depolarization, compared to an age- and sex-matched healthy control’s PBMCs. Conclusions: A novel variant in the MT-CYB:m.15309T>C (Ile188Thr) gene was identified in a patient with optic nerve damage and the LHON phenotype without any additional systemic features and atypical presentation of the disease with late onset of visual function recovery. The pathogenicity of the variant is supported by proteomic analysis and the mitochondrial dysfunction observed in the patient’s PBMCs. © 2025 by the authors. - Some of the metrics are blocked by yourconsent settings
Publication Chronic Diabetic Complications: Current Challenges and Opportunities(2022) ;Migdalis, Ilias N. (7004151559) ;Czupryniak, Leszek (7004014515) ;Lalic, Nebojsa (13702597500) ;Papanas, Nikolaos (12763313600)Valensi, Paul (7103187761)[No abstract available] - Some of the metrics are blocked by yourconsent settings
Publication Effects of aerobic training on the risk of coronary artery disease by Duke Treadmill Score in type 2 diabetes mellitus and cardiometabolic health; [Effetti dell’allenamento aerobico sul rischio di coronaropatia nel diabete mellito di tipo 2 e sulle condizioni cardiometaboliche secondo il Duke Treadmill Score](2019) ;Trebinjac, Divna (57210580420) ;Petronic, Ivana (25121756800) ;Lalic, Nebojsa (13702597500) ;Cirovic, Dragana (25121527800) ;Nikolic, Dejan (26023650800)Stojkovic, Jasna (57200810273)BACKGROUND: We aimed to investigate the impact of eight-week aerobic exercise training on the risk of coronary heart disease onset by Duke Treadmill Score (DTS), metabolic equivalent of task (MET), and metabolic syndrome parameters, as well as correlation between those parameters in patients with type 2 diabetes mellitus. There is the clinical value of DTS for the risk stratification as well as strong association between DTS and the combined outcomes of cardiac death, nonfatal myocardial infarction, congestive heart failure and revascularization. METHODS: Sixty patients in stable clinical condition and well-regulated diabetic status conducted all phases of the study. Participants performed treadmill exercise testing using standard Bruce protocol before and after study. Rate of perceived exertion (RPE), systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting glucose levels (GLU), waist circumference (WC), triglyceride levels (TRI), high-sensitivity C-reactive protein (hs-CRP), probability of 5-year mortality (P5YM), probability of significant coronary heart disease (pCHD), probability of severe coronary disease (sCHD), DTS and METs levels were evaluated before and after study as well as correlation between DTS, METs and other parameters. RESULTS: The average values of DTS of 4.67 obtained before study indicated a moderate risk for CHD, while average values of 5.61 obtained after study indicated a low risk for CHD. Linear regression model stressed that variable DTS is statistically significant predictor, where higher values of DTS leads to the higher score values of METs. There is statistically significant difference in METs (P<0.001), RPE (P<0.001), sCHD (P=0.038), P5YM (P=0.033) values after study. CONCLUSIONS: Our study suggests that eight-week aerobic exercise training could significantly reduce the risk stratification by DTS from the intermediate to the moderate risk group for coronary heart disease in patients with type 2 diabetes mellitus. Lower values of DTS in women obtained in our research should be investigated in the future studies. Additionally, we have shown that increasing in METs will ultimately bring to decreased mortality in participants with diabetes mellitus type 2 and could significantly improve cardio-metabolic health that indicates the enormous potential value of exercise training. © 2019 EDIZIONI MINERVA MEDICA - Some of the metrics are blocked by yourconsent settings
Publication Effects of aerobic training on the risk of coronary artery disease by Duke Treadmill Score in type 2 diabetes mellitus and cardiometabolic health; [Effetti dell’allenamento aerobico sul rischio di coronaropatia nel diabete mellito di tipo 2 e sulle condizioni cardiometaboliche secondo il Duke Treadmill Score](2019) ;Trebinjac, Divna (57210580420) ;Petronic, Ivana (25121756800) ;Lalic, Nebojsa (13702597500) ;Cirovic, Dragana (25121527800) ;Nikolic, Dejan (26023650800)Stojkovic, Jasna (57200810273)BACKGROUND: We aimed to investigate the impact of eight-week aerobic exercise training on the risk of coronary heart disease onset by Duke Treadmill Score (DTS), metabolic equivalent of task (MET), and metabolic syndrome parameters, as well as correlation between those parameters in patients with type 2 diabetes mellitus. There is the clinical value of DTS for the risk stratification as well as strong association between DTS and the combined outcomes of cardiac death, nonfatal myocardial infarction, congestive heart failure and revascularization. METHODS: Sixty patients in stable clinical condition and well-regulated diabetic status conducted all phases of the study. Participants performed treadmill exercise testing using standard Bruce protocol before and after study. Rate of perceived exertion (RPE), systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting glucose levels (GLU), waist circumference (WC), triglyceride levels (TRI), high-sensitivity C-reactive protein (hs-CRP), probability of 5-year mortality (P5YM), probability of significant coronary heart disease (pCHD), probability of severe coronary disease (sCHD), DTS and METs levels were evaluated before and after study as well as correlation between DTS, METs and other parameters. RESULTS: The average values of DTS of 4.67 obtained before study indicated a moderate risk for CHD, while average values of 5.61 obtained after study indicated a low risk for CHD. Linear regression model stressed that variable DTS is statistically significant predictor, where higher values of DTS leads to the higher score values of METs. There is statistically significant difference in METs (P<0.001), RPE (P<0.001), sCHD (P=0.038), P5YM (P=0.033) values after study. CONCLUSIONS: Our study suggests that eight-week aerobic exercise training could significantly reduce the risk stratification by DTS from the intermediate to the moderate risk group for coronary heart disease in patients with type 2 diabetes mellitus. Lower values of DTS in women obtained in our research should be investigated in the future studies. Additionally, we have shown that increasing in METs will ultimately bring to decreased mortality in participants with diabetes mellitus type 2 and could significantly improve cardio-metabolic health that indicates the enormous potential value of exercise training. © 2019 EDIZIONI MINERVA MEDICA - Some of the metrics are blocked by yourconsent settings
Publication Erratum: Report from the 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group. [Cardiovasc Diabetol., 16, (2017) (35)] DOI: 10.1186/s12933-017-0508-8(2017) ;Schnell, Oliver (7006418720) ;Standl, Eberhard (7102763320) ;Catrinoiu, Doina (34167569600) ;Genovese, Stefano (7004412674) ;Lalic, Nebojsa (13702597500) ;Skra, Jan (57195093600) ;Valensi, Paul (7103187761) ;Rahelic, Dario (6505508151)Ceriello, Antonio (7102926564)Following publication of the original article [1], author Antonio Ceriello requested that a correction be published in relation to his affiliations. His correct affiliations have been updated in this erratum. This correction is very important for the correct assignment of funds to his Institutions. © 2017 The Author(s). - Some of the metrics are blocked by yourconsent settings
Publication Expert Opinion: A Call for Basal Insulin Titration in Patients with Type 2 Diabetes in Daily Practice: Southeast European Perspective(2021) ;Hancu, Nicolae (6602113821) ;Janez, Andrej (6603143804) ;Lalic, Nebojsa (13702597500) ;Papanas, Nikolaos (12763313600) ;Rahelic, Dario (6505508151) ;Roman, Gabriela (35777030800) ;Serafinceanu, Cristian (6506421865) ;Tentolouris, Nikolaos (9248284000) ;Vukovic, Blaženko (56801532300) ;Ylli, Agron (6506483888)Tankova, Tsvetalina (8242458100)Therapeutic inertia related to insulin treatment, i.e. delays in initiation, especially titration of basal insulin, is a significant problem in daily practice in Southeast European countries. This phenomenon can be traced back to several patient-, physician- and health system-related factors. In recognition of the issue of inadequate insulin titration, 11 leading experts from countries in this region held a consensus-seeking meeting to review the current status of insulin initiation after non-insulin treatment and the potential barriers to insulin titration to provide an algorithm and tools for outpatient physicians and for patients aimed at optimizing basal insulin titration. The experts reached a consensus on the majority of the topics and proposed recommendations on how clinical inertia can be overcome. The outcomes of the meeting have been summarized in this paper. © 2021, The Author(s). - Some of the metrics are blocked by yourconsent settings
Publication Impact of hypoglycaemia on patient-reported outcomes from a global, 24-country study of 27,585 people with type 1 and insulin-treated type 2 diabetes(2017) ;Khunti, Kamlesh (7005202765) ;Alsifri, Saud (8544458600) ;Aronson, Ronnie (36449128700) ;Cigrovski Berković, Maja (24314547400) ;Enters-Weijnen, Catherine (55781980300) ;Forsén, Tom (7004157622) ;Galstyan, Gagik (6701438348) ;Geelhoed-Duijvestijn, Petronella (6603172226) ;Goldfracht, Margalit (6507968492) ;Gydesen, Helge (56418984200) ;Kapur, Rahul (57002646900) ;Lalic, Nebojsa (13702597500) ;Ludvik, Bernhard (55839735300) ;Moberg, Erik (7005272766) ;Pedersen-Bjergaard, Ulrik (6701798053)Ramachandran, Ambady (7102252827)Aims Data on the impact of hypoglycaemia on patients’ daily lives and diabetes self-management, particularly in developing countries, are lacking. The aim of this study was to assess fear of, and responses to, hypoglycaemia experienced by patients globally. Materials and methods This non-interventional, multicentre, 4-week prospective study using self-assessment questionnaires and patient diaries consisted of 27,585 patients, ≥18 years, with type 1 diabetes (n = 8022) or type 2 diabetes (n = 19,563) treated with insulin for >12 months, at 2004 sites in 24 countries worldwide. Results Increased blood glucose monitoring (69.7%) and seeking medical assistance (62.0%) were the most common responses in the 4 weeks following hypoglycaemic events for patients with type 1 diabetes and type 2 diabetes, respectively. Approximately 44% of patients with type 1 diabetes or type 2 diabetes increased calorie intake in response to a hypoglycaemic episode. Following hypoglycaemia, 3.9% (type 1 diabetes) and 6.2% (type 2 diabetes) of patients took leave from work or study. Regional differences in fear of, and responses to, hypoglycaemia were evident – in particular, a lower level of hypoglycaemic fear and utilisation of healthcare resources in Northern Europe and Canada. Conclusions Hypoglycaemia has a major impact on patients and their behaviour. These global data for the first time reveal regional variations in response to hypoglycaemia and highlight the importance of patient education and management strategies. © 2017 The Authors - Some of the metrics are blocked by yourconsent settings
Publication Impact of hypoglycaemia on patient-reported outcomes from a global, 24-country study of 27,585 people with type 1 and insulin-treated type 2 diabetes(2017) ;Khunti, Kamlesh (7005202765) ;Alsifri, Saud (8544458600) ;Aronson, Ronnie (36449128700) ;Cigrovski Berković, Maja (24314547400) ;Enters-Weijnen, Catherine (55781980300) ;Forsén, Tom (7004157622) ;Galstyan, Gagik (6701438348) ;Geelhoed-Duijvestijn, Petronella (6603172226) ;Goldfracht, Margalit (6507968492) ;Gydesen, Helge (56418984200) ;Kapur, Rahul (57002646900) ;Lalic, Nebojsa (13702597500) ;Ludvik, Bernhard (55839735300) ;Moberg, Erik (7005272766) ;Pedersen-Bjergaard, Ulrik (6701798053)Ramachandran, Ambady (7102252827)Aims Data on the impact of hypoglycaemia on patients’ daily lives and diabetes self-management, particularly in developing countries, are lacking. The aim of this study was to assess fear of, and responses to, hypoglycaemia experienced by patients globally. Materials and methods This non-interventional, multicentre, 4-week prospective study using self-assessment questionnaires and patient diaries consisted of 27,585 patients, ≥18 years, with type 1 diabetes (n = 8022) or type 2 diabetes (n = 19,563) treated with insulin for >12 months, at 2004 sites in 24 countries worldwide. Results Increased blood glucose monitoring (69.7%) and seeking medical assistance (62.0%) were the most common responses in the 4 weeks following hypoglycaemic events for patients with type 1 diabetes and type 2 diabetes, respectively. Approximately 44% of patients with type 1 diabetes or type 2 diabetes increased calorie intake in response to a hypoglycaemic episode. Following hypoglycaemia, 3.9% (type 1 diabetes) and 6.2% (type 2 diabetes) of patients took leave from work or study. Regional differences in fear of, and responses to, hypoglycaemia were evident – in particular, a lower level of hypoglycaemic fear and utilisation of healthcare resources in Northern Europe and Canada. Conclusions Hypoglycaemia has a major impact on patients and their behaviour. These global data for the first time reveal regional variations in response to hypoglycaemia and highlight the importance of patient education and management strategies. © 2017 The Authors - Some of the metrics are blocked by yourconsent settings
Publication Influence of IL-6, TNF-a and hs-CRP on insulin sensitivity in patients after laparoscopic cholecystectomy or open hernia repair(2018) ;Micic, Dusan (37861889200) ;Lalic, Nebojsa (13702597500) ;Djukic, Vladimir (57210262273) ;Stankovic, Sanja (7005216636) ;Trajkovic, Goran (9739203200) ;Oluic, Branislav (57201078229)Polovina, Snezana (35071643300)Background: The aim of this study was to investigate the influence of IL-6, TNF-a and hs-CRP on insulin sensitivity during postoperative follow-up in patients with laparoscopic cholecystectomy (LC) or open hernia repair (OHR). Methods: 65 patients were studied: after laparoscopic cholecystectomy (LC; n=40) or open hernia repair (OHR; n=25). Glucose, insulin, hs-CRP, IL-6 and TNF-a were determined at day 0 (before the operation) and at days 1, 3 and 7 (after the operation). Results: There were no difference between LC and OHR groups concerning age, BMI, glucose, insulin, hs-CRP, IL-6 and TNF-a at day 0. hs-CRP increased at day 1, 3 and 7 vs. day 0 (p<0.0005), without difference between groups (p=0.561). IL-6 increased at day 1 and day 3 vs. day 0 (p<0.005). IL-6 was higher at day 1 in OHR group in comparison with LC group (p=0.044). There were no differences in TNF-a levels between LC and OHR groups (p=0.056). There was increase of HOMA-IR at day 1, 3 and 7 vs. day 0 (p<0.0005) in both groups. Significantly higher increase of HOMA-IR was in OHR group compared with LC group at day 1 (p=0.045). There was a positive correlation between hs-CRP and HOMA-IR (r=0.46; p=0.025) and between IL-6 and HOMA-IR at day 1 in OHR group (r=0.44; p=0.030). Conclusions: Significantly higher HOMA-IR was found in OHR group compared with LC. Positive correlation between hs-CRP and IL-6 with HOMA-IR in OHR group at day 1, indicate possible influence of this mediators on impairment of insulin sensitivity. © 2018 Society of Medical Biochemists of Serbia and Montenegro. All rights reserved. - Some of the metrics are blocked by yourconsent settings
Publication Influence of IL-6, TNF-a and hs-CRP on insulin sensitivity in patients after laparoscopic cholecystectomy or open hernia repair(2018) ;Micic, Dusan (37861889200) ;Lalic, Nebojsa (13702597500) ;Djukic, Vladimir (57210262273) ;Stankovic, Sanja (7005216636) ;Trajkovic, Goran (9739203200) ;Oluic, Branislav (57201078229)Polovina, Snezana (35071643300)Background: The aim of this study was to investigate the influence of IL-6, TNF-a and hs-CRP on insulin sensitivity during postoperative follow-up in patients with laparoscopic cholecystectomy (LC) or open hernia repair (OHR). Methods: 65 patients were studied: after laparoscopic cholecystectomy (LC; n=40) or open hernia repair (OHR; n=25). Glucose, insulin, hs-CRP, IL-6 and TNF-a were determined at day 0 (before the operation) and at days 1, 3 and 7 (after the operation). Results: There were no difference between LC and OHR groups concerning age, BMI, glucose, insulin, hs-CRP, IL-6 and TNF-a at day 0. hs-CRP increased at day 1, 3 and 7 vs. day 0 (p<0.0005), without difference between groups (p=0.561). IL-6 increased at day 1 and day 3 vs. day 0 (p<0.005). IL-6 was higher at day 1 in OHR group in comparison with LC group (p=0.044). There were no differences in TNF-a levels between LC and OHR groups (p=0.056). There was increase of HOMA-IR at day 1, 3 and 7 vs. day 0 (p<0.0005) in both groups. Significantly higher increase of HOMA-IR was in OHR group compared with LC group at day 1 (p=0.045). There was a positive correlation between hs-CRP and HOMA-IR (r=0.46; p=0.025) and between IL-6 and HOMA-IR at day 1 in OHR group (r=0.44; p=0.030). Conclusions: Significantly higher HOMA-IR was found in OHR group compared with LC. Positive correlation between hs-CRP and IL-6 with HOMA-IR in OHR group at day 1, indicate possible influence of this mediators on impairment of insulin sensitivity. © 2018 Society of Medical Biochemists of Serbia and Montenegro. All rights reserved. - Some of the metrics are blocked by yourconsent settings
Publication Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review(2020) ;Janež, Andrej (6603143804) ;Guja, Cristian (6603582360) ;Mitrakou, Asimina (7004179428) ;Lalic, Nebojsa (13702597500) ;Tankova, Tsvetalina (8242458100) ;Czupryniak, Leszek (7004014515) ;Tabák, Adam G. (7003480687) ;Prazny, Martin (6701722128) ;Martinka, Emil (6701691301)Smircic-Duvnjak, Lea (57208387970)Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin < 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared with older basal insulins include reduced injection burden, better efficacy, lower risk of hypoglycemic episodes (especially nocturnal), and reduced weight gain. For prandial glycemic control, any rapid-acting prandial analogue (aspart, glulisine, lispro) is preferred over regular human insulin. Faster-acting insulin aspart is a relatively new option with the advantage of better postprandial glucose coverage. Frequent blood glucose measurements along with patient education on insulin dosing based on carbohydrate counting, premeal blood glucose, and anticipated physical activity is paramount, as is education on the management of blood glucose under different circumstances. Plain Language Summary: Plain language summary is available for this article. © 2020, The Author(s). - Some of the metrics are blocked by yourconsent settings
Publication Maternal and Fetal Outcomes among Pregnant Women with Diabetes(2022) ;Gojnic, Miroslava (9434266300) ;Todorovic, Jovana (7003376825) ;Stanisavljevic, Dejana (23566969700) ;Jotic, Aleksandra (13702545200) ;Lukic, Ljiljana (24073403700) ;Milicic, Tanja (24073432600) ;Lalic, Nebojsa (13702597500) ;Lalic, Katarina (13702563300) ;Stoiljkovic, Milica (57215024953) ;Stanisavljevic, Tamara (57252613700) ;Stefanovic, Aleksandar (8613866900) ;Stefanovic, Katarina (57210793310) ;Vrzic-Petronijevic, Svetlana (14520050800) ;Petronijevic, Milos (21739995200) ;Terzic-Supic, Zorica (15840732000) ;Macura, Maja (57219966636) ;Perovic, Milan (36543025300) ;Babic, Sandra (57489797700) ;Piperac, Pavle (57188729382) ;Jovanovic, Marija (59805031900) ;Parapid, Bijana (6506582242) ;Doklestic, Krisitna (37861226800) ;Cerovic, Radmila (57489666400) ;Djurasevic, Sinisa (57211577561)Dugalic, Stefan (26648755300)The aim of this study was to examine the differences in pregnancy complications, delivery characteristics, and neonatal outcomes between women with type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), and gestational diabetes mellitus (GDM). This study included all pregnant women with diabetes in pregnancy in Belgrade, Serbia, between 2010 and 2020. The total sample consisted of 6737 patients. In total, 1318 (19.6%) patients had T1DM, 138 (2.0%) had T2DM, and 5281 patients (78.4%) had GDM. Multivariate logistic regression with the type of diabetes as an outcome variable showed that patients with T1DM had a lower likelihood of vaginal delivery (OR: 0.73, 95% CI: 0.64–0.83), gestational hypertension (OR: 0.47, 95% CI: 0.36–0.62), higher likelihood of chronic hypertension (OR: 1.88, 95% CI: 1.55–2.29),and a higher likelihood ofgestational age at delivery before 37 weeks (OR: 1.38, 95% CI: 1.18–1.63) compared to women with GDM. Multivariate logistic regression showed that patients with T2DM had a lower likelihood ofgestational hypertension compared to women with GDM (OR: 0.37, 95% CI: 0.15–0.92).Our results indicate that the highest percentage of diabetes in pregnancy is GDM, and the existence of differences in pregnancy complications, childbirth characteristics, and neonatal outcomes are predominantly between women with GDM and women with T1DM. © 2022 by the authors. Licensee MDPI, Basel, Switzerland. - Some of the metrics are blocked by yourconsent settings
Publication Maternal and Fetal Outcomes among Pregnant Women with Diabetes(2022) ;Gojnic, Miroslava (9434266300) ;Todorovic, Jovana (7003376825) ;Stanisavljevic, Dejana (23566969700) ;Jotic, Aleksandra (13702545200) ;Lukic, Ljiljana (24073403700) ;Milicic, Tanja (24073432600) ;Lalic, Nebojsa (13702597500) ;Lalic, Katarina (13702563300) ;Stoiljkovic, Milica (57215024953) ;Stanisavljevic, Tamara (57252613700) ;Stefanovic, Aleksandar (8613866900) ;Stefanovic, Katarina (59912734800) ;Vrzic-Petronijevic, Svetlana (14520050800) ;Petronijevic, Milos (21739995200) ;Terzic-Supic, Zorica (15840732000) ;Macura, Maja (57219966636) ;Perovic, Milan (36543025300) ;Babic, Sandra (57489797700) ;Piperac, Pavle (57188729382) ;Jovanovic, Marija (59805031900) ;Parapid, Bijana (6506582242) ;Doklestic, Krisitna (37861226800) ;Cerovic, Radmila (57489666400) ;Djurasevic, Sinisa (57211577561)Dugalic, Stefan (26648755300)The aim of this study was to examine the differences in pregnancy complications, delivery characteristics, and neonatal outcomes between women with type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM), and gestational diabetes mellitus (GDM). This study included all pregnant women with diabetes in pregnancy in Belgrade, Serbia, between 2010 and 2020. The total sample consisted of 6737 patients. In total, 1318 (19.6%) patients had T1DM, 138 (2.0%) had T2DM, and 5281 patients (78.4%) had GDM. Multivariate logistic regression with the type of diabetes as an outcome variable showed that patients with T1DM had a lower likelihood of vaginal delivery (OR: 0.73, 95% CI: 0.64–0.83), gestational hypertension (OR: 0.47, 95% CI: 0.36–0.62), higher likelihood of chronic hypertension (OR: 1.88, 95% CI: 1.55–2.29),and a higher likelihood ofgestational age at delivery before 37 weeks (OR: 1.38, 95% CI: 1.18–1.63) compared to women with GDM. Multivariate logistic regression showed that patients with T2DM had a lower likelihood ofgestational hypertension compared to women with GDM (OR: 0.37, 95% CI: 0.15–0.92).Our results indicate that the highest percentage of diabetes in pregnancy is GDM, and the existence of differences in pregnancy complications, childbirth characteristics, and neonatal outcomes are predominantly between women with GDM and women with T1DM. © 2022 by the authors. Licensee MDPI, Basel, Switzerland. - Some of the metrics are blocked by yourconsent settings
Publication Metabolic characteristics of prehypertension: Role of classification criteria and gender(2009) ;Natali, Andrea (57200684714) ;Muscelli, Elza (6603717726) ;Casolaro, Arturo (6603318788) ;Nilsson, Peter (7202850334) ;Melander, Ole (57216058959) ;Lalic, Nebojsa (13702597500) ;Ferrannini, Ele (34975069200)Petrie, John R (7103382892)OBJECTIVE: We tested whether men and women in the European Society of Hypertension (ESH) high normal and normal blood pressure (BP) categories, all included in the the Seventh Joint National Committee (JNC 7) prehypertension group, share similar metabolic characteristics and whether they differ from men and women with optimal BP (<120/80 mmHg). METHODS: BP (multiple measurements with a standardized automatic device), insulin sensitivity (euglycaemic clamp), oral glucose tolerance test (OGTT), carotid intimaĝ€"media- thickness (IMT, echo), family history (questionnaire), physical activity (accelerometer), and anthropometrics (bioimpedance) were evaluated in the 1384 healthy European individuals ranging from 30ĝ€"60 years participating in the multicentre study Relationship between Insulin Sensitivity and Cardiovascular disease (RISC). RESULTS: BMI and waist-to-hip ratio were higher (both P < 0.05 adjusted for age and recruiting centre) in men and women with high normal (but not normal) BP with respect to optimal BP. Similarly, in women (after adjustment for study centre, age, physical activity, and waist), serum triglycerides and carotid IMT were higher in those with high normal (but not normal) BP; moreover, in this group there was a higher prevalence of glucose-intolerance (21.8 versus 9.7%, P ≤ 0.02) and insulin sensitivity tended to be lower (P ≤ 0.07). Insulin sensitivity and diastolic blood pressure were weakly related variables displaying a nonlinear association with a threshold below the normal BP values and no interaction with family history of hypertension. CONCLUSION: The JNC 7 category prehypertension identifies a dishomogeneous group of individuals whereas the ESH classification, particularly in women, was more accurate in identifying both the predisease and the healthy phenotype. Insulin resistance is not a major characteristic of the condition of prehypertension. © 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins. - Some of the metrics are blocked by yourconsent settings
Publication Metabolic characteristics of prehypertension: Role of classification criteria and gender(2009) ;Natali, Andrea (57200684714) ;Muscelli, Elza (6603717726) ;Casolaro, Arturo (6603318788) ;Nilsson, Peter (7202850334) ;Melander, Ole (57216058959) ;Lalic, Nebojsa (13702597500) ;Ferrannini, Ele (34975069200)Petrie, John R (7103382892)OBJECTIVE: We tested whether men and women in the European Society of Hypertension (ESH) high normal and normal blood pressure (BP) categories, all included in the the Seventh Joint National Committee (JNC 7) prehypertension group, share similar metabolic characteristics and whether they differ from men and women with optimal BP (<120/80 mmHg). METHODS: BP (multiple measurements with a standardized automatic device), insulin sensitivity (euglycaemic clamp), oral glucose tolerance test (OGTT), carotid intimaĝ€"media- thickness (IMT, echo), family history (questionnaire), physical activity (accelerometer), and anthropometrics (bioimpedance) were evaluated in the 1384 healthy European individuals ranging from 30ĝ€"60 years participating in the multicentre study Relationship between Insulin Sensitivity and Cardiovascular disease (RISC). RESULTS: BMI and waist-to-hip ratio were higher (both P < 0.05 adjusted for age and recruiting centre) in men and women with high normal (but not normal) BP with respect to optimal BP. Similarly, in women (after adjustment for study centre, age, physical activity, and waist), serum triglycerides and carotid IMT were higher in those with high normal (but not normal) BP; moreover, in this group there was a higher prevalence of glucose-intolerance (21.8 versus 9.7%, P ≤ 0.02) and insulin sensitivity tended to be lower (P ≤ 0.07). Insulin sensitivity and diastolic blood pressure were weakly related variables displaying a nonlinear association with a threshold below the normal BP values and no interaction with family history of hypertension. CONCLUSION: The JNC 7 category prehypertension identifies a dishomogeneous group of individuals whereas the ESH classification, particularly in women, was more accurate in identifying both the predisease and the healthy phenotype. Insulin resistance is not a major characteristic of the condition of prehypertension. © 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins.