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Use of fast-acting insulin aspart in insulin pump therapy in clinical practice.
Evans, M, Ceriello, A, Danne, T, De Block, C, DeVries, JH, Lind, M, Mathieu, C, Nørgaard, K, Renard, E, Wilmot, EG
Diabetes, obesity & metabolism. 2019;(9):2039-2047
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Abstract
Fast-acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) containing the additional excipients niacinamide and L-arginine. The improved pharmacological profile and greater early glucose-lowering action of faster aspart compared with IAsp suggests that faster aspart may be advantageous for people with diabetes using continuous subcutaneous insulin infusion (CSII). The recent onset 5 trial was the first to evaluate the efficacy and safety of an ultra-fast-acting insulin in CSII therapy in a large number of participants with type 1 diabetes (T1D). Non-inferiority of faster aspart to IAsp in terms of change from baseline in HbA1c was confirmed, with an estimated treatment difference (ETD) of 0.09% (95% CI, 0.01; 0.17; P < 0.001 for non-inferiority [0.4% margin]). Faster aspart was superior to IAsp in terms of change from baseline in 1-hour post-prandial glucose (PPG) increment after a meal test (ETD [95% CI], -0.91 mmol/L [-1.43; -0.39]; P = 0.001), with statistically significant improvements also at 30 minutes and 2 hours. The overall rate of severe or blood glucose-confirmed hypoglycaemia was not statistically significantly different between treatments, with an estimated rate ratio of 1.00 (95% CI, 0.85; 1.16). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and the 4-week run-in periods (4 vs 0). Experience from clinical practice indicates that all pump settings should be reviewed when initiating faster aspart with CSII, and that the use of continuous glucose monitoring or flash glucose monitoring, along with a good understanding of meal content and bolus type, may also facilitate optimal use. This review summarizes the available clinical evidence for faster aspart administered via CSII and highlights practical considerations based on clinical experience that may help healthcare providers and individuals with T1D successfully initiate and adjust faster aspart with CSII.
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Five-Year Predictors of Insulin Initiation in People with Type 2 Diabetes under Real-Life Conditions.
Gentile, S, Strollo, F, Viazzi, F, Russo, G, Piscitelli, P, Ceriello, A, Giorda, C, Guida, P, Fioretto, P, Pontremoli, R, et al
Journal of diabetes research. 2018;:7153087
Abstract
We performed a real-life analysis of clinical and laboratory parameters, in orally treated T2DM patients aiming at identifying predictors of insulin treatment initiation. Overall, 366955 patients (55.8% males, age 65 ± 11 years, diabetes duration 7 ± 8 years) were followed up between 2004 and 2011. Each patient was analyzed step-by-step until either eventually starting insulin treatment or getting to the end of the follow-up period. Patients switching to insulin showed a worse global risk profile, longer disease duration (10 ± 9 years vs. 6 ± 7 years, respectively; p < 0.001), higher HbA1c (8.0 ± 1.6% vs. 7.2 ± 1.5%, respectively; p < 0.001), higher triglycerides, a greater prevalence of arterial hypertension, antihypertensive, lipid-lowering and aspirin treatment, a higher rate of nonproliferative/proliferative retinopathy, and a nearly 4 times lower prevalence of the "diet alone." They also showed a higher prevalence of subjects with eGFR < 60 ml/min/1.73 m2 (24.0% vs. 16.2%, respectively; p < 0.001). Multivariate analysis identified diabetes duration, HbA1c, triglyceride and low HDL-C values, presence of retinopathy or renal dysfunction, and sulphonylurea utilization (the risk being approximately 3 times greater in the latter case) as independent predictors of insulin treatment initiation. LDL-C, lipid-lowering treatment, and overweight/obese seem to be protective. Results of tree analysis showed that patients on sulphonylurea, with high HbA1c, eGFR below 50 ml/min/1.73 m2, and at least 5-year disease duration, are at very high risk to start insulin treatment. We have to stick to this real-life picture, of course, until enough data are collected on patients treated with innovative medications which are expected to improve beta cell survival and further delay treatment-related insulin requirement.
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Liraglutide improves metabolic parameters and carotid intima-media thickness in diabetic patients with the metabolic syndrome: an 18-month prospective study.
Rizzo, M, Rizvi, AA, Patti, AM, Nikolic, D, Giglio, RV, Castellino, G, Li Volti, G, Caprio, M, Montalto, G, Provenzano, V, et al
Cardiovascular diabetology. 2016;(1):162
Abstract
BACKGROUND Liraglutide, a GLP-1 analogue, exerts several beneficial non-glycemic effects in patients with type-2 diabetes (T2DM), such as those on body weight, blood pressure, plasma lipids and inflammation markers. However, the effects of liraglutide on cardiovascular (CV) risk markers in subjects with the metabolic syndrome (MetS) are still largely unknown. We herein explored its effects on various cardio-metabolic risk markers of the MetS in subjects with T2DM. METHODS We performed an 18-month prospective, real-world study. All subjects had T2DM and the MetS based on the AHA/NHLBI criteria. Subjects with a history of a major CV event were excluded. One hundred-twenty-one subjects (71 men and 50 women; mean age: 62 ± 9 years) with T2DM and the MetS, who were naïve to incretin-based therapies and treated with metformin only, were included. Liraglutide (1.2 mg/day) was added to metformin (1500-3000 mg/day) for the entire study. Fasting plasma samples for metabolic parameters were collected and carotid-intima media thickness (cIMT) was assessed by B-mode real-time ultrasound at baseline and every 6 months thereafter. RESULTS There was a significant reduction in waist circumference, body mass index, fasting glycemia, HbA1c, total- and LDL-cholesterol, triglycerides, and cIMT during the 18-month follow-up. Correlation analysis showed a significant association between changes in cIMT and triglycerides (r = 0.362; p < 0.0001). The MetS prevalence significantly reduced during the study, and the 26% of subjects no longer fulfilled the criteria for the MetS after 18 months. CONCLUSIONS Liraglutide improves cardio-metabolic risk factors in subjects with the MetS in a real-world study. Trial Registration ClinicalTrials.gov: NCT01715428.
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The role of self-monitoring of blood glucose in patients treated with SGLT-2 inhibitors: a European expert recommendation.
Schnell, O, Alawi, H, Battelino, T, Ceriello, A, Diem, P, Felton, AM, Harno, K, Satman, I, Vergès, B
Journal of diabetes science and technology. 2014;(4):783-90
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Abstract
The role for the novel treatment approach of sodium-glucose cotransporter-2 (SGLT-2) in type 2 diabetes is increasing. Structured self-monitoring of blood glucose (SMBG), based on a less intensive and a more intensive scheme, may contribute to an optimization of SGLT-2 inhibitor based treatment. The current expert recommendation suggests individualized approaches of SMBG, using simple and clinically applicable schemes. Potential benefits of SMBG in SGLT-2 inhibitor based treatment approaches are early assessment of treatment success or failure, timely modification of treatment, detection of hypoglycemic episodes, assessment of glucose excursions, and support of diabetes management and education. The length and frequency of SMBG should depend on the clinical setting and the quality of metabolic control.
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Effect of pioglitazone versus metformin on cardiovascular risk markers in type 2 diabetes.
Genovese, S, De Berardis, G, Nicolucci, A, Mannucci, E, Evangelista, V, Totani, L, Pellegrini, F, Ceriello, A
Advances in therapy. 2013;(2):190-202
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INTRODUCTION Besides its critical role in metabolic homeostasis, peroxisome proliferator-activated receptor (PPAR)-γ modulates several cellular responses involved in atherothrombosis. This multicenter, double-blind, randomized study investigated the effects of two oral hypoglycemic agents on markers of inflammation, platelet activation, thrombogenesis, and oxidative stress in patients with type 2 diabetes. METHODS AND RESULTS The primary objective of this study was to evaluate the effect on C-reactive protein (CRP) after a 16-week treatment period with either pioglitazone or metformin. Additionally, markers of vascular inflammatory response, platelet activation, thrombogenesis, oxidative stress, glucose, and lipid metabolism, as well as liver function, were measured. In total, 50 patients completed the study. Pioglitazone-treated patients were found to have statistically significantly larger decreases in mean CRP levels (-0.4 mg/dL) compared to those treated with metformin (-0.2 mg/dL) (P=0.04), as well as greater reductions in levels of mean fasting plasma glucose (-27 vs. -9 mg/dL; P=0.01), serum insulin (-2 vs. -1.9 mU/L; P=0.014), homeostatic model assessment (HOMA) (-1.2 vs. -0.9; P=0.015), and E-selectin (-12.4 vs. +3.4 μg/mL; P=0.01). Mean glycated hemoglobin (HbA1c) levels decreased in both treatment groups from baseline to week 16 (-0.4% in the pioglitazone group, -0.2% in the metformin group; P=0.36). Pioglitazone treatment was also found to be associated with a statistically significant increase in total cholesterol levels (+10 mg/dL in the pioglitazone arm, -3 mg/dL in the metformin arm; P=0.05) and a decrease in liver enzyme levels. CONCLUSIONS The favorable changes in markers of systemic and vascular inflammatory response with pioglitazone suggest that it may positively influence the atherothrombotic process in type 2 diabetes.
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Vitamin C further improves the protective effect of GLP-1 on the ischemia-reperfusion-like effect induced by hyperglycemia post-hypoglycemia in type 1 diabetes.
Ceriello, A, Novials, A, Ortega, E, Canivell, S, Pujadas, G, La Sala, L, Bucciarelli, L, Rondinelli, M, Genovese, S
Cardiovascular diabetology. 2013;:97
Abstract
BACKGROUND It has been reported that hyperglycemia following hypoglycemia produces an ischemia-reperfusion-like effect in type 1 diabetes. In this study the possibility that GLP-1 has a protective effect on this phenomenon has been tested. METHODS 15 type 1 diabetic patients underwent to five experiments: a period of two hours of hypoglycemia followed by two hours of normo-glycemia or hyperglycemia with the concomitant infusion of GLP-1 or vitamin C or both. At baseline, after 2 and 4 hours, glycemia, plasma nitrotyrosine, plasma 8-iso prostaglandin F2alpha, sCAM-1a, IL-6 and flow mediated vasodilation were measured. RESULTS After 2 h of hypoglycemia, flow mediated vasodilation significantly decreased, while sICAM-1, 8-iso-PGF2a, nitrotyrosine and IL-6 significantly increased. While recovering with normoglycemia was accompanied by a significant improvement of endothelial dysfunction, oxidative stress and inflammation, a period of hyperglycemia after hypoglycemia worsens all these parameters. These effects were counterbalanced by GLP-1 and better by vitamin C, while the simultaneous infusion of both almost completely abolished the effect of hyperglycemia post hypoglycemia. CONCLUSIONS This study shows that GLP-1 infusion, during induced hyperglycemia post hypoglycemia, reduces the generation of oxidative stress and inflammation, improving the endothelial dysfunction, in type 1 diabetes. Furthermore, the data support that vitamin C and GLP-1 may have an additive protective effect in such condition.
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Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study.
Rossi, MC, Nicolucci, A, Di Bartolo, P, Bruttomesso, D, Girelli, A, Ampudia, FJ, Kerr, D, Ceriello, A, Mayor, Cde L, Pellegrini, F, et al
Diabetes care. 2010;(1):109-15
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OBJECTIVE Widespread use of carbohydrate counting is limited by its complex education. In this study we compared a Diabetes Interactive Diary (DID) with standard carbohydrate counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction. RESEARCH DESIGN AND METHODS Adults with type 1 diabetes were randomly assigned to DID (group A, n = 67) or standard education (group B, n = 63) and followed for 6 months. A subgroup also completed the SF-36 Health Survey (SF-36) and World Health Organization-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ) at each visit. RESULTS Of 130 patients (aged 35.7 +/- 9.4 years; diabetes duration 16.5 +/- 10.5 years), 11 dropped out. Time for education was 6 h (range 2-15 h) in group A and 12 h (2.5-25 h) in group B (P = 0.07). A1C reduction was similar in both groups (group A from 8.2 +/- 0.8 to 7.8 +/- 0.8% and group B from 8.4 +/- 0.7 to 7.9 +/- 1.1%; P = 0.68). Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight. No severe hypoglycemic episode occurred. WHO-DTSQ scores increased significantly more in group A (from 26.7 +/- 4.4 to 30.3 +/- 4.5) than in group B (from 27.5 +/- 4.8 to 28.6 +/- 5.1) (P = 0.04). Role Physical, General Health, Vitality, and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS DID is at least as effective as traditional carbohydrate counting education, allowing dietary freedom for a larger proportion of type 1 diabetic patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality-of-life dimensions.
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Lowering glucose to prevent adverse cardiovascular outcomes in a critical care setting.
Ceriello, A, Zarich, SW, Testa, R
Journal of the American College of Cardiology. 2009;(5 Suppl):S9-13
Abstract
High admission blood glucose levels after acute myocardial infarction are common and associated with an increased risk of death in patients with or without diabetes. Hyperglycemia is associated with altered myocardial blood flow and energetics and can lead to a pro-oxidative/proinflammatory state. The use of intensive insulin treatment has shown superior benefits in the treatment of hyperglycemia versus glucose-insulin-potassium infusion, particularly in critical care settings.