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[PMID]:28185141
[Au] Autor:Hövelmann U; Heise T; Nosek L; Sassenfeld B; Thomsen KMD; Haahr H
[Ad] Endereço:Profil Institut für Stoffwechselforschung GmbH, Hellersbergstrasse 9, 41460, Neuss, Germany.
[Ti] Título:Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions.
[So] Source:Clin Drug Investig;37(5):503-509, 2017 May.
[Is] ISSN:1179-1918
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Fast-acting insulin aspart (faster aspart) is insulin aspart set in a new formulation with faster initial absorption after subcutaneous administration. This study investigated the pharmacokinetic properties, including the absolute bioavailability, of faster aspart when administered subcutaneously in the abdomen, upper arm or thigh. METHODS: In a randomised, open-label, crossover trial, 21 healthy male subjects received a single injection of faster aspart at five dosing visits: 0.2 U/kg subcutaneously in the abdomen, upper arm and thigh, intramuscularly in the thigh and 0.02 U/kg intravenously. Blood sampling for pharmacokinetics was performed pre-dose and frequently thereafter until 12 h post-dose (8 h after intravenous administration). RESULTS: Onset of appearance (~3 min), time to 50% of maximum concentration (t ; ~20 min) and time to maximum concentration (t ; ~55 min) were all similar between injection regions. Early exposure within the first 2 h after injection (AUC and AUC ) as well as maximum concentration (C ) were comparable for the abdomen and upper arm, but were ~25% lower for the thigh as seen previously for other mealtime insulin products. Total exposure (AUC ) was similar for the abdomen, upper arm and thigh, and absolute bioavailability was ~80% after subcutaneous administration of faster aspart in all three injection regions. CONCLUSION: The current study supports the ultra-fast pharmacokinetic characteristics of faster aspart across different injection regions, with administration in the abdomen and upper arm resulting in greater early exposure than in the thigh. ClinicalTrials.gov identifier: NCT02089451.
[Mh] Termos MeSH primário: Hipoglicemiantes/administração & dosagem
Hipoglicemiantes/farmacocinética
Insulina Aspart/administração & dosagem
Insulina Aspart/farmacocinética
[Mh] Termos MeSH secundário: Abdome/fisiologia
Adulto
Braço/fisiologia
Disponibilidade Biológica
Glicemia/efeitos dos fármacos
Glicemia/metabolismo
Química Farmacêutica
Estudos Cross-Over
Método Duplo-Cego
Feminino
Seres Humanos
Injeções Intramusculares
Injeções Subcutâneas
Masculino
Coxa da Perna/fisiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170526
[Lr] Data última revisão:
170526
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170211
[St] Status:MEDLINE
[do] DOI:10.1007/s40261-017-0499-y


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[PMID]:28156005
[Au] Autor:O'Neill SM; Kenny LC; Khashan AS; West HM; Smyth RM; Kearney PM
[Ad] Endereço:Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, 5th Floor, Cork University Maternity Hospital, Wilton, Cork, Munster, Ireland.
[Ti] Título:Different insulin types and regimens for pregnant women with pre-existing diabetes.
[So] Source:Cochrane Database Syst Rev;2:CD011880, 2017 02 03.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe, pen) and types of insulin (e.g. fast-acting insulin, human insulin). OBJECTIVES: To assess the effects of different insulin types and different insulin regimens in pregnant women with pre-existing type 1 or type 2 diabetes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 October 2016), ClinicalTrials.gov (17 October 2016), the WHO International Clinical Trials Registry Platform (ICTRP; 17 October 2016), and the reference lists of retrieved studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared different insulin types and regimens in pregnant women with pre-existing diabetes.We had planned to include cluster-RCTs, but none were identified. We excluded quasi-randomised controlled trials and cross-over trials. We included studies published in abstract form and contacted the authors for further details when applicable. Conference abstracts were superseded by full publications. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: The findings in this review were based on very low-quality evidence, from single, small sample sized trial estimates, with wide confidence intervals (CI), some of which crossed the line of no effect; many of the prespecified outcomes were not reported. Therefore, they should be interpreted with caution. We included five trials that included 554 women and babies (four open-label, multi-centre, two-arm trials; one single centre, four-arm RCT). All five trials were at a high or unclear risk of bias due to lack of blinding, unclear methods of randomisation, and selective reporting of outcomes. Pooling of data from the trials was not possible, as each trial looked at a different comparison.1. One trial (N = 33 women) compared Lispro insulin with regular insulin and provided very low-quality evidence for the outcomes. There were seven episodes of pre-eclampsia in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (risk ratio (RR) 0.68, 95% CI 0.35 to 1.30). There were five caesarean sections in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (RR 0.59, 95% CI 0.25 to 1.39). There were no cases of fetal anomaly in the Lispro group and one in the regular insulin group, with no clear difference between the groups (RR 0.35, 95% CI 0.02 to 8.08). Macrosomia, perinatal deaths, episodes of birth trauma including shoulder dystocia, nerve palsy, and fracture, and the composite outcome measure of neonatal morbidity were not reported.2. One trial (N = 42 women) compared human insulin to animal insulin, and provided very low-quality evidence for the outcomes. There were no cases of macrosomia in the human insulin group and two in the animal insulin group, with no clear difference between the groups (RR 0.22, 95% CI 0.01 to 4.30). Perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy and fracture and the composite outcome measure of neonatal morbidity were not reported.3. One trial (N = 93 women) compared pre-mixed insulin (70 NPH/30 REG) to self-mixed, split-dose insulin and provided very low-quality evidence to support the outcomes. Two cases of macrosomia were reported in the pre-mixed insulin group and four in the self-mixed insulin group, with no clear difference between the two groups (RR 0.49, 95% CI 0.09 to 2.54). There were seven cases of caesarean section (for cephalo-pelvic disproportion) in the pre-mixed insulin group and 12 in the self-mixed insulin group, with no clear difference between groups (RR 0.57, 95% CI 0.25 to 1.32). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome measure of neonatal morbidity were not reported.4. In the same trial (N = 93 women), insulin injected with a Novolin pen was compared to insulin injected with a conventional needle (syringe), which provided very low-quality evidence to support the outcomes. There was one case of macrosomia in the pen group and five in the needle group, with no clear difference between the different insulin regimens (RR 0.21, 95% CI 0.03 to 1.76). There were five deliveries by caesarean section in the pen group compared with 14 in the needle group; women were less likely to deliver via caesarean section when insulin was injected with a pen compared to a conventional needle (RR 0.38, 95% CI 0.15 to 0.97). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture, and the composite outcome measure of neonatal morbidity were not reported.5. One trial (N = 223 women) comparing insulin Aspart with human insulin reported none of the review's primary outcomes: macrosomia, perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia. nerve palsy, or fracture, or the composite outcome measure of neonatal morbidity.6. One trial (N = 162 women) compared insulin Detemir with NPH insulin, and supported the outcomes with very low-quality evidence. There were three cases of major fetal anomalies in the insulin Detemir group and one in the NPH insulin group, with no clear difference between the groups (RR 3.15, 95% CI 0.33 to 29.67). Macrosomia, perinatal death, pre-eclampsia, caesarean section, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome of neonatal morbidity were not reported. AUTHORS' CONCLUSIONS: With limited evidence and no meta-analyses, as each trial looked at a different comparison, no firm conclusions could be made about different insulin types and regimens in pregnant women with pre-existing type 1 or 2 diabetes. Further research is warranted to determine who has an increased risk of adverse pregnancy outcome. This would include larger trials, incorporating adequate randomisation and blinding, and key outcomes that include macrosomia, pregnancy loss, pre-eclampsia, caesarean section, fetal anomalies, and birth trauma.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 1/tratamento farmacológico
Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/uso terapêutico
Insulina/uso terapêutico
Complicações na Gravidez/tratamento farmacológico
Gravidez em Diabéticas/tratamento farmacológico
[Mh] Termos MeSH secundário: Feminino
Seres Humanos
Hipoglicemiantes/administração & dosagem
Insulina/administração & dosagem
Insulina Aspart/uso terapêutico
Insulina Detemir/uso terapêutico
Insulina Lispro/uso terapêutico
Gravidez
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Hypoglycemic Agents); 0 (Insulin); 0 (Insulin Lispro); 4FT78T86XV (Insulin Detemir); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170619
[Lr] Data última revisão:
170619
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170204
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD011880.pub2


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[PMID]:28133990
[Au] Autor:Kelton KA; Perk S; Loveland S; Perez-Nieves M; Fu H; Peng X
[Ad] Endereço:a Medical Decision Modeling , Indianapolis , IN , USA.
[Ti] Título:Economic outcomes with the conversion of insulin delivery methods in hospitals.
[So] Source:J Med Econ;20(5):533-540, 2017 May.
[Is] ISSN:1941-837X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To evaluate the insulin wastage and associated acquisition costs when switching from individual patient supply (IPS) of 3-mL pens of rapid-acting insulin (RAI) aspart to floor stock (FS) dispensing of 3-mL vials of RAI lispro, and with conversion from IPS of 3-mL pens to centralized unit dose (CUD) of 10-mL vials of basal insulin detemir. METHODS: Data from September 2010 to December 2012 from three hospitals in the Roper St. Francis Healthcare (RSFH) were used: Roper Hospital (368 beds), Bon Secours St. Francis Hospital (204 beds), and Roper St. Francis Mt. Pleasant Hospital (85 beds). Insulin wastage and associated acquisition costs were estimated using regression models. RESULTS: The conversion from IPS of 3-mL pens of insulin aspart to FS of 3-mL vials of lispro was associated with a significant decrease in insulin wastage (204,042 IUs; p < .001) and equated to an average savings of $106.40 per patient at all three hospitals combined (p < .001). For basal insulin, conversion from IPS of 3-mL pens of insulin detemir to CUD of 10-mL vials was associated with a significant decrease in insulin wastage at Roper and St. Francis Hospitals (p < .001). For Mt. Pleasant Hospital, the decrease was not statistically significant. The predicted average reduction in insulin wastage per month was 52,542.9 IUs (p < .001) at all three hospitals combined. CONCLUSIONS: Switching RAI from IPS of 3-mL pens of insulin aspart to one-time unit dose insulin lispro dispensed from FS 3-mL vials as needed significantly reduced insulin wastage and associated acquisition costs at the three combined hospitals. Conversion of basal insulin from IPS of 3-mL pens of insulin detemir to CUD of 10-mL vials of insulin detemir was associated with a significant reduction in insulin wastage and associated acquisition costs at three hospitals combined.
[Mh] Termos MeSH primário: Diabetes Mellitus/tratamento farmacológico
Hipoglicemiantes/economia
Insulina/economia
Serviço de Farmácia Hospitalar/economia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Criança
Pré-Escolar
Sistemas de Liberação de Medicamentos
Feminino
Seres Humanos
Hipoglicemiantes/administração & dosagem
Insulina/administração & dosagem
Insulina Aspart/administração & dosagem
Insulina Aspart/economia
Insulina Lispro/administração & dosagem
Insulina Lispro/economia
Masculino
Meia-Idade
Modelos Econométricos
Estudos Retrospectivos
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Hypoglycemic Agents); 0 (Insulin); 0 (Insulin Lispro); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171025
[Lr] Data última revisão:
171025
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170131
[St] Status:MEDLINE
[do] DOI:10.1080/13696998.2017.1288126


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[PMID]:28099755
[Au] Autor:Kristensen PL; Tarnow L; Bay C; Nørgaard K; Jensen T; Parving HH; Perrild H; Beck-Nielsen H; Christiansen JS; Thorsteinsson B; Pedersen-Bjergaard U
[Ad] Endereço:Nordsjaellands Hospital Hillerød, Department of Cardiology, Nephrology and Endocrinology, Hillerød, Denmark.
[Ti] Título:Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes.
[So] Source:Diabet Med;34(5):625-631, 2017 May.
[Is] ISSN:1464-5491
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIMS: To assess the difference between analogue and human insulin with regard to nocturnal glucose profiles and risk of hypoglycaemia in people with recurrent severe hypoglycaemia. METHODS: A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA 65 ± 12 mmol/mol (8.1 ± 1.1%), mean ± sd duration of diabetes 30 ± 14 years], who participated in a 2-year randomized, crossover trial of basal-bolus therapy with insulin detemir/insulin aspart or human NPH insulin/human regular insulin (the HypoAna trial) were studied for 2 nights during each treatment. Venous blood was drawn hourly during sleep. Primary endpoints were nocturnal glucose profiles and occurrence of hypoglycaemia (blood glucose ≤ 3.9 mmol/l). RESULTS: During insulin analogue treatment, the mean nocturnal plasma glucose level was significantly higher than during treatment with human insulin (10.6 vs 8.1 mmol/l). The fasting plasma glucose level was similar between the treatments. Nocturnal hypoglycaemia was registered during 41/101 nights (41%) in the human insulin arm and 19/117 nights (16%) in the insulin analogue arm, corresponding to a hazard ratio of 0.26 (95% CI 0.14 to 0.45; P < 0.0001) with insulin analogue. CONCLUSIONS: Treatment with insulin analogue reduces the occurrence of nocturnal hypoglycaemia assessed by nocturnal glucose profiles in people with Type 1 diabetes prone to severe hypoglycaemia. Nocturnal glucose profiles provide a more comprehensive assessment of clinical benefit of insulin regimens as compared to conventional recording of hypoglycaemia.
[Mh] Termos MeSH primário: Glicemia/efeitos dos fármacos
Diabetes Mellitus Tipo 1/tratamento farmacológico
Hipoglicemia/prevenção & controle
Insulina/análogos & derivados
Insulina/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Idoso
Glicemia/metabolismo
Ritmo Circadiano/efeitos dos fármacos
Estudos Cross-Over
Diabetes Mellitus Tipo 1/sangue
Diabetes Mellitus Tipo 1/epidemiologia
Feminino
Seres Humanos
Hipoglicemia/induzido quimicamente
Hipoglicemia/epidemiologia
Insulina/efeitos adversos
Insulina Aspart/administração & dosagem
Insulina Aspart/efeitos adversos
Insulina Isófana/administração & dosagem
Insulina Isófana/efeitos adversos
Insulina de Ação Prolongada/administração & dosagem
Insulina de Ação Prolongada/efeitos adversos
Masculino
Meia-Idade
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Insulin); 0 (Insulin, Long-Acting); 53027-39-7 (Insulin, Isophane); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170928
[Lr] Data última revisão:
170928
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170119
[St] Status:MEDLINE
[do] DOI:10.1111/dme.13317


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[PMID]:28055230
[Au] Autor:Bode BW; Johnson JA; Hyveled L; Tamer SC; Demissie M
[Ad] Endereço:1 Atlanta Diabetes Associates , Atlanta, Georgia .
[Ti] Título:Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion.
[So] Source:Diabetes Technol Ther;19(1):25-33, 2017 Jan.
[Is] ISSN:1557-8593
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Faster aspart is insulin aspart (IAsp) in a new formulation, which in continuous subcutaneous insulin infusion (CSII) in subjects with type 1 diabetes has shown a faster onset and offset of glucose-lowering effect than IAsp. METHODS: This double-blind, randomized, crossover active-controlled trial compared 2-h postprandial plasma glucose (PPG) response, following 2 weeks of CSII with faster aspart or IAsp. Primary endpoint: mean change in PPG 2 h after a standardized meal test (ΔPG ). Subjects (n = 43) had masked continuous glucose monitoring (CGM) throughout. RESULTS: Faster aspart provided a statistically significantly greater glucose-lowering effect following the meal versus IAsp: ΔPG : 3.03 mmol/L versus 4.02 mmol/L (54.68 mg/dL vs. 72.52 mg/dL); estimated treatment difference (ETD) [95% CI]: -0.99 mmol/L [-1.95; -0.03] (-17.84 mg/dL [-35.21; -0.46]; P = 0.044). One hour postmeal, PG levels were -1.64 mmol/L (-29.47 mg/dL) lower with faster aspart versus IAsp (P = 0.006). Interstitial glucose (IG) profiles supported these findings; the largest differences were observed at breakfast: 9.08 versus 9.56 mmol/L (163.57 vs. 172.19 mg/dL; ETD [95% CI]: -0.48 mmol/L [-0.97; 0.01]; -8.62 mg/dL [-17.49; 0.24]; P = 0.057). Duration of low IG levels (≤3.9 mmol/L [70 mg/dL] per 24 h) was statistically significantly shorter for faster aspart versus IAsp (2.03 h vs. 2.45 h; ETD [95% CI]: -0.42 [-0.72; -0.11]; P = 0.008). No unexpected safety findings were observed. CONCLUSIONS: CSII delivery of faster aspart had a greater glucose-lowering effect than IAsp after a meal test. CGM results recorded throughout all meals supported this finding, with less time spent with low IG levels.
[Mh] Termos MeSH primário: Glicemia/metabolismo
Diabetes Mellitus Tipo 1/tratamento farmacológico
Hipoglicemiantes/uso terapêutico
Insulina Aspart/uso terapêutico
Período Pós-Prandial/efeitos dos fármacos
[Mh] Termos MeSH secundário: Adulto
Estudos Cross-Over
Diabetes Mellitus Tipo 1/sangue
Método Duplo-Cego
Feminino
Seres Humanos
Hipoglicemiantes/administração & dosagem
Infusões Subcutâneas
Insulina Aspart/administração & dosagem
Sistemas de Infusão de Insulina
Masculino
Meia-Idade
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171103
[Lr] Data última revisão:
171103
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170106
[St] Status:MEDLINE
[do] DOI:10.1089/dia.2016.0350


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[PMID]:27995731
[Au] Autor:Radhakutty A; Stranks JL; Mangelsdorf BL; Drake SM; Roberts GW; Zimmermann AT; Stranks SN; Thompson CH; Burt MG
[Ad] Endereço:School of Medicine, Flinders University, Adelaide, Australia.
[Ti] Título:Treatment of prednisolone-induced hyperglycaemia in hospitalized patients: Insights from a randomized, controlled study.
[So] Source:Diabetes Obes Metab;19(4):571-578, 2017 Apr.
[Is] ISSN:1463-1326
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIM: Prednisolone causes hyperglycaemia predominantly between midday and midnight. Consequently, glargine-based basal-bolus insulin regimens may under treat daytime hyperglycaemia and cause nocturnal hypoglycaemia. We investigated whether an isophane-based insulin regimen is safer and more effective than a glargine-based regimen in hospitalized patients. MATERIALS AND METHODS: Fifty inpatients prescribed ≥20 mg/day prednisolone acutely with (1) finger prick blood glucose level (BGL) ≥15 mmol/L or (2) BGLs ≥10 mmol/L within the previous 24 hours were randomized to either insulin isophane or glargine before breakfast and insulin aspart before meals. The initial daily insulin dose was 0.5 U/kg bodyweight or 130% of the current daily insulin dose. Glycaemic control was assessed using a continuous glucose monitoring system. RESULTS: On Day 1, there were no significant differences in percentage of time outside a target glucose range of 4 to 10 mmol/L (41.3% ± 5.5% vs 50.0% ± 5.7%, P = .28), mean daily glucose (10.2 ± 0.7 vs 10.8 ± 0.8 mmol/L, P = .57) or glucose <4 mmol/L (2.2% ± 1.1% vs 2.0% ± 1.3%, P = .92) in patients randomized to isophane and glargine. In patients treated for 3 days, the prednisolone dose was reduced ( P = .02) and the insulin dose was increased over time ( P = .02), but the percentage of time outside the 4 to 10 mmol/L glucose range did not differ over time ( P = .45) or between groups ( P = .24). CONCLUSIONS: There were no differences in the efficacy or safety of the isophane and glargine-based insulin regimens. We recommend an initial daily insulin dose of 0.5 units/kg bodyweight if not on insulin, a greater than 30% increase in pre-prednisolone insulin dose and larger insulin dose adjustments in patients with prednisolone-induced hyperglycaemia.
[Mh] Termos MeSH primário: Hiperglicemia/tratamento farmacológico
Hipoglicemiantes/administração & dosagem
Insulina Glargina/administração & dosagem
Insulina Isófana/administração & dosagem
Prednisolona/efeitos adversos
[Mh] Termos MeSH secundário: Idoso
Glicemia/efeitos dos fármacos
Esquema de Medicação
Feminino
Hospitalização
Seres Humanos
Hiperglicemia/induzido quimicamente
Hipoglicemia/induzido quimicamente
Pacientes Internados
Insulina/administração & dosagem
Insulina Aspart/administração & dosagem
Masculino
Refeições
Meia-Idade
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); 0 (Insulin); 2ZM8CX04RZ (Insulin Glargine); 53027-39-7 (Insulin, Isophane); 9PHQ9Y1OLM (Prednisolone); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171102
[Lr] Data última revisão:
171102
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161221
[St] Status:MEDLINE
[do] DOI:10.1111/dom.12859


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[PMID]:27873152
[Au] Autor:Heise T; Hövelmann U; Zijlstra E; Stender-Petersen K; Jacobsen JB; Haahr H
[Ad] Endereço:Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraße 9, 41460, Neuss, Germany. tim.heise@profil.com.
[Ti] Título:A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus.
[So] Source:Drugs Aging;34(1):29-38, 2017 Jan.
[Is] ISSN:1179-1969
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Due to population aging, an increasing number of elderly patients with diabetes use insulin. It is therefore important to investigate the characteristics of new insulins in this population. Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with faster absorption. This study investigated the pharmacological properties of faster aspart in elderly subjects with type 1 diabetes mellitus (T1DM). METHODS: In a randomised, double-blind, two-period crossover trial, 30 elderly (≥65 years) and 37 younger adults (18-35 years) with T1DM received single subcutaneous faster aspart or IAsp dosing (0.2 U/kg) and underwent an euglycaemic clamp (target 5.5 mmol/L) for up to 12 h. RESULTS: The pharmacokinetic and pharmacodynamic time profiles were left-shifted for faster aspart versus IAsp. In each age group, onset of appearance occurred approximately twice as fast (~3 min earlier) and early exposure (area under the concentration-time curve [AUC] for serum IAsp from time zero to 30 min [AUC ]) was greater (by 86% in elderly and 67% in younger adults) for faster aspart than for IAsp. Likewise, onset of action occurred 10 min faster in the elderly and 9 min faster in younger adults, and early glucose-lowering effect (AUC for the glucose infusion rate [GIR] from time zero to 30 min [AUC ]) was greater (by 109%) for faster aspart than for IAsp in both age groups. Total exposure (AUC ) and the maximum concentration (C ) for faster aspart were greater (by 30 and 28%, respectively) in elderly than in younger adults. No age group differences were seen for the total (AUC ) or maximum (GIR ) glucose-lowering effect. CONCLUSION: This study demonstrated that the ultra-fast pharmacological properties of faster aspart are similar in elderly subjects and younger adults with T1DM. ClinicalTrials.gov Identifier: NCT02003677.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 1/tratamento farmacológico
Hipoglicemiantes/farmacocinética
Hipoglicemiantes/uso terapêutico
Insulina Aspart/farmacocinética
Insulina Aspart/uso terapêutico
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Envelhecimento/sangue
Envelhecimento/efeitos dos fármacos
Glicemia/análise
Química Farmacêutica
Estudos Cross-Over
Diabetes Mellitus Tipo 1/sangue
Relação Dose-Resposta a Droga
Método Duplo-Cego
Feminino
Técnica Clamp de Glucose
Seres Humanos
Hipoglicemiantes/administração & dosagem
Hipoglicemiantes/química
Insulina Aspart/administração & dosagem
Insulina Aspart/química
Insulina de Ação Curta/administração & dosagem
Insulina de Ação Curta/química
Insulina de Ação Curta/farmacocinética
Insulina de Ação Curta/uso terapêutico
Masculino
Fatores de Tempo
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); 0 (Insulin, Short-Acting); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170821
[Lr] Data última revisão:
170821
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161123
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1007/s40266-016-0418-6


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[PMID]:27709762
[Au] Autor:Heise T; Zijlstra E; Nosek L; Rikte T; Haahr H
[Ad] Endereço:Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.
[Ti] Título:Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial.
[So] Source:Diabetes Obes Metab;19(2):208-215, 2017 Feb.
[Is] ISSN:1463-1326
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIM: To evaluate the pharmacological characteristics of faster-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) during continuous subcutaneous insulin infusion (CSII). METHODS: In this randomized, double-blind, crossover trial, 48 men and women aged 18 to 64 years with type 1 diabetes mellitus (T1DM) received faster aspart and IAsp as a 0.15 U/kg bolus dose via CSII, on top of a basal rate (0.02 U/kg/h), in a glucose clamp setting (target 5.5 mmol/L). RESULTS: After a CSII bolus dose, the pharmacokinetic/pharmacodynamic profiles for faster aspart were left-shifted compared with those for IAsp. For faster aspart vs IAsp, the early glucose-lowering effect (area under the curve for glucose infusion rate [GIR] ) was approximately 2-fold higher (least squares means 24.9 vs 11.4 mg/kg; estimated ratio faster aspart/IAsp 2.18, 95% confidence interval [CI] [1.33; 5.04]; P = .002), onset of glucose-lowering effect (time to early 50% of maximum GIR) occurred 11.1 minutes earlier (41.1 vs 52.3 minutes; 95% CI faster aspart - IAsp [-15.4; -6.9]; P<.001), and offset of glucose-lowering effect (time to late 50% of maximum GIR) occurred 24.0 minutes earlier (214.7 vs 238.7 minutes; 95% CI [-38.9; -9.1]; P=.002). Likewise, significantly greater early exposure and significantly earlier onset and offset of exposure were observed for faster aspart vs IAsp. Faster aspart and IAsp were both well tolerated. CONCLUSIONS: In patients with T1DM using CSII, faster aspart better mimics the endogenous prandial insulin secretion and action than does IAsp. Faster aspart therefore has the potential to provide clinical benefits over current rapid-acting insulins in the insulin pump setting.
[Mh] Termos MeSH primário: Glicemia/efeitos dos fármacos
Diabetes Mellitus Tipo 1/tratamento farmacológico
Hipoglicemiantes/farmacologia
Insulina Aspart/farmacologia
Sistemas de Infusão de Insulina
[Mh] Termos MeSH secundário: Adulto
Área Sob a Curva
Glicemia/metabolismo
Estudos Cross-Over
Diabetes Mellitus Tipo 1/metabolismo
Método Duplo-Cego
Feminino
Técnica Clamp de Glucose
Seres Humanos
Hipoglicemiantes/administração & dosagem
Infusões Subcutâneas
Insulina Aspart/administração & dosagem
Análise dos Mínimos Quadrados
Masculino
Meia-Idade
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171101
[Lr] Data última revisão:
171101
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161007
[St] Status:MEDLINE
[do] DOI:10.1111/dom.12803


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[PMID]:27560769
[Au] Autor:Onishi Y; Yamada K; Zacho J; Ekelund J; Iwamoto Y
[Ad] Endereço:The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.
[Ti] Título:Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial.
[So] Source:J Diabetes Investig;8(2):210-217, 2017 Mar.
[Is] ISSN:2040-1124
[Cp] País de publicação:Japan
[La] Idioma:eng
[Ab] Resumo:AIMS/INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit-to-unit from twice-daily basal or pre-mix insulin to twice-daily IDegAsp in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: In this 6-week, open-label, parallel-group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre-trial insulin. During the trial, insulin doses were adjusted according to a pre-specified algorithm to achieve pre-breakfast and pre-dinner plasma glucose of 4.4-7.2 mmol/L. RESULTS: No severe hypoglycemic episodes occurred. There were no statistically significant differences in rates of confirmed hypoglycemia (rate ratio IDegAsp/BIAsp 30: 0.63, 95% confidence interval: 0.31-1.30) and confirmed nocturnal hypoglycemia (rate ratio: 0.49, 95% confidence interval: 0.10-2.38) for IDegAsp vs BIAsp 30. The hypoglycemia rate for IDegAsp was constant over the 6 weeks of treatment. IDegAsp and BIAsp 30 were both safe and well tolerated. Reduction in fasting plasma glucose was statistically significantly greater for IDegAsp than for BIAsp 30 (estimated treatment difference, IDegAsp-BIAsp 30: -1.6 mmol/L, 95% confidence interval: -2.4 to -0.8). The apparent decrease in mean postprandial plasma glucose increment (IDegAsp: 4.2-3.8 mmol/L; BIAsp 30: 4.5-2.8 mmol/L) was not statistically significantly different between treatments (estimated treatment difference: 1.0 mmol/L, 95% confidence interval: -0.1 to 2.2). CONCLUSIONS: Switching unit-to-unit from basal or pre-mix insulin to IDegAsp seems not to be associated with any concerns related to hypoglycemia or general safety in Japanese patients with type 2 diabetes.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/uso terapêutico
Insulina Aspart/uso terapêutico
Insulina de Ação Prolongada/uso terapêutico
[Mh] Termos MeSH secundário: Idoso
Glicemia/efeitos dos fármacos
Feminino
Seres Humanos
Hipoglicemia/induzido quimicamente
Hipoglicemiantes/administração & dosagem
Insulina Aspart/administração & dosagem
Insulina Aspart/efeitos adversos
Insulina de Ação Prolongada/administração & dosagem
Insulina de Ação Prolongada/efeitos adversos
Japão
Masculino
Meia-Idade
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); 0 (Insulin, Long-Acting); 54Q18076QB (insulin degludec); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170327
[Lr] Data última revisão:
170327
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160826
[St] Status:MEDLINE
[do] DOI:10.1111/jdi.12569


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[PMID]:27130075
[Au] Autor:Cichosz SL; Lundby-Christensen L; Johansen MD; Tarnow L; Almdal TP; Hejlesen OK; Group TC
[Ad] Endereço:Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
[Ti] Título:Prediction of excessive weight gain in insulin treated patients with type 2 diabetes.
[So] Source:J Diabetes;9(4):325-331, 2017 Apr.
[Is] ISSN:1753-0407
[Cp] País de publicação:Australia
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Weight gain is an ongoing challenge when initiating insulin therapy in patients with type 2 diabetes mellitus (T2DM). However, if prediction of insulin-associated weight gain was possible on an individual level, targeted initiatives could be implemented to reduce weight gain. The aim of the present study was to identify predictors of weight gain in insulin-treated patients with T2DM. METHODS: In all, 412 individuals with T2DM were, in addition to metformin or placebo, randomized into 18-month treatment groups with three different insulin analog treatment regimens (biphasic, aspart, detemir). Participants with excessive weight gain were defined as the group with weight gain in the 4th quartile (>6.2 kg).We developed a pattern classification method to predict individuals prone to excessive weight gain. RESULTS: Over the 18-month treatment period, median weight gain among all 412 patients was 2.4 kg (95% prediction interval [PI] -5.6, 12.4 kg), whereas median weight gain for those in the upper 4th quartile (n = 103) was 8.9 kg (95% PI 6.3, 15.2 kg). No clinical baseline data were strong predictors of excessive weight gain. However, the weight gain during the first 3 months of the trial and the subsequent dose of insulin yielded a useful predictor for weight gain at the 18-month follow-up. Combining these two predictors into a prediction model with other clinical available information produced a receiver operating characteristic area under the curve of 0.80. CONCLUSIONS: We have developed a prediction model that could help identify a substantial proportion of individuals with T2DM prone to large weight gain during insulin therapy.
[Mh] Termos MeSH primário: Insulinas Bifásicas/uso terapêutico
Diabetes Mellitus Tipo 2/tratamento farmacológico
Insulina Aspart/uso terapêutico
Insulina Detemir/uso terapêutico
Ganho de Peso/efeitos dos fármacos
[Mh] Termos MeSH secundário: Idoso
Insulinas Bifásicas/efeitos adversos
Glicemia/metabolismo
Distribuição de Qui-Quadrado
Diabetes Mellitus Tipo 2/sangue
Diabetes Mellitus Tipo 2/fisiopatologia
Quimioterapia Combinada
Feminino
Seguimentos
Hemoglobina A Glicada/metabolismo
Seres Humanos
Hipoglicemiantes/efeitos adversos
Hipoglicemiantes/uso terapêutico
Insulina Aspart/efeitos adversos
Insulina Detemir/efeitos adversos
Modelos Logísticos
Masculino
Metformina/uso terapêutico
Meia-Idade
Prognóstico
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Biphasic Insulins); 0 (Blood Glucose); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents); 4FT78T86XV (Insulin Detemir); 9100L32L2N (Metformin); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160501
[St] Status:MEDLINE
[do] DOI:10.1111/1753-0407.12418



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