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[PMID]:29370218
[Au] Autor:Yale JF; Pettus JH; Brito-Sanfiel M; Lavalle-Gonzalez F; Merino-Trigo A; Stella P; Chevalier S; Buzzetti R
[Ad] Endereço:Department of Medicine, McGill University, Montreal, Canada.
[Ti] Título:The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3.
[So] Source:PLoS One;13(1):e0190579, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:AIMS: To evaluate the effect of concomitant dipeptidyl peptidase IV inhibitor (DPPIVi) use on efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in people with type 2 diabetes on oral antihyperglycaemic drugs. METHODS: A post hoc patient-level meta-analysis was performed using data from EDITION 2 (basal insulin [N = 811]) and EDITION 3 (insulin-naïve [N = 878]), multicentre, randomised, open-label, parallel-group, phase 3a trials of similar design. Endpoints analysed included HbA1c, hypoglycaemia and adverse events, investigated in subgroups of participants with and without concomitant DPPIVi use. RESULTS: Of 1689 participants randomised, 107 (13%, Gla-300) and 133 (16%, Gla-100) received DPPIVi therapy. The least squares mean change in HbA1c (baseline to month 6) was comparable between treatment groups, irrespective of DPPIVi use (no evidence of heterogeneity of treatment effect across subgroups, p = 0.753), although group sizes were unbalanced. The cumulative mean number of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemic events, and the risk and annualised rate of such events, were consistently lower for Gla-300 than Gla-100 during the night (between 00:00 and 05:59 h) or at any time of day (24 h period), irrespective of DPPIVi use. Severe hypoglycaemia occurred in 8/838 and 10/844 participants in the Gla-300 and Gla-100 groups, respectively, and was not affected by DPPIVi use. The adverse event profile was similar between treatment groups and DPPIVi subgroups. CONCLUSIONS: Glycaemic control with Gla-300 was comparable to Gla-100, with less hypoglycaemia during the night and at any time of day (24 h), irrespective of concomitant DPPIVi use. TRIAL REGISTRATION: ClinicalTrials.gov NCT01499095; NCT01676220.
[Mh] Termos MeSH primário: Glicemia/análise
Diabetes Mellitus Tipo 2/tratamento farmacológico
Inibidores da Dipeptidil Peptidase IV/uso terapêutico
Hipoglicemia/tratamento farmacológico
Hipoglicemiantes/uso terapêutico
Insulina Glargina/uso terapêutico
[Mh] Termos MeSH secundário: Idoso
Peso Corporal
Diabetes Mellitus Tipo 2/sangue
Relação Dose-Resposta a Droga
Quimioterapia Combinada
Feminino
Seres Humanos
Insulina Glargina/administração & dosagem
Masculino
Meia-Idade
Estudos Multicêntricos como Assunto
Ensaios Clínicos Controlados Aleatórios como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Dipeptidyl-Peptidase IV Inhibitors); 0 (Hypoglycemic Agents); 2ZM8CX04RZ (Insulin Glargine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180126
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0190579


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[PMID]:29241887
[Au] Autor:Dawoud D; Fenu E; Higgins B; Wonderling D; Amiel SA
[Ad] Endereço:National Guideline Centre, Royal College of Physicians, London, UK; Clinical Pharmacy Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt. Electronic address: dalia.dawoud@rcplondon.ac.uk.
[Ti] Título:Basal Insulin Regimens for Adults with Type 1 Diabetes Mellitus: A Cost-Utility Analysis.
[So] Source:Value Health;20(10):1279-1287, 2017 12.
[Is] ISSN:1524-4733
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: To assess the cost-effectiveness of basal insulin regimens for adults with type 1 diabetes mellitus in England. METHODS: A cost-utility analysis was conducted in accordance with the National Institute for Health and Care Excellence reference case. The UK National Health Service and personal and social services perspective was used and a 3.5% discount rate was applied for both costs and outcomes. Relative effectiveness estimates were based on a systematic review of published trials and a Bayesian network meta-analysis. The IMS CORE Diabetes Model was used, in which net monetary benefit (NMB) was calculated using a threshold of £20,000 per quality-adjusted life-year (QALY) gained. A wide range of sensitivity analyses were conducted. RESULTS: Insulin detemir (twice daily) [iDet (bid)] had the highest mean QALY gain (11.09 QALYs) and NMB (£181,456) per patient over the model time horizon. Compared with the lowest cost strategy (insulin neutral protamine Hagedorn once daily), it had an incremental cost-effectiveness ratio of £7844/QALY gained. Insulin glargine (od) [iGlarg (od)] and iDet (od) were ranked as second and third, with NMBs of £180,893 and £180,423, respectively. iDet (bid) remained the most cost-effective treatment in all the sensitivity analyses performed except when high doses were assumed (>30% increment compared with other regimens), where iGlarg (od) ranked first. CONCLUSIONS: iDet (bid) is the most cost-effective regimen, providing the highest QALY gain and NMB. iGlarg (od) and iDet (od) are possible options for those for whom the iDet (bid) regimen is not acceptable or does not achieve required glycemic control.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 1/tratamento farmacológico
Hipoglicemiantes/administração & dosagem
Insulina Detemir/administração & dosagem
Insulina Glargina/administração & dosagem
Insulina Isófana/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Teorema de Bayes
Glicemia/efeitos dos fármacos
Simulação por Computador
Análise Custo-Benefício
Diabetes Mellitus Tipo 1/economia
Inglaterra
Feminino
Seres Humanos
Hipoglicemiantes/economia
Insulina Detemir/economia
Insulina Glargina/economia
Insulina Isófana/economia
Masculino
Meia-Idade
Modelos Econômicos
Anos de Vida Ajustados por Qualidade de Vida
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); 2ZM8CX04RZ (Insulin Glargine); 4FT78T86XV (Insulin Detemir); 53027-39-7 (Insulin, Isophane)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180202
[Lr] Data última revisão:
180202
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:29241884
[Au] Autor:Brekke L; Buysman E; Grabner M; Ke X; Xie L; Baser O; Wei W
[Ad] Endereço:Optum, Eden Prairie, MN, USA. Electronic address: lee.brekke@optum.com.
[Ti] Título:The Use of Decomposition Methods in Real-World Treatment Benefits Evaluation for Patients with Type 2 Diabetes Initiating Different Injectable Therapies: Findings from the INITIATOR Study.
[So] Source:Value Health;20(10):1252-1259, 2017 12.
[Is] ISSN:1524-4733
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Determining characteristics of patients likely to benefit from a particular treatment could help physicians set personalized targets. OBJECTIVES: To use decomposition methodology on real-world data to identify the relative contributions of treatment effects and patients' baseline characteristics. METHODS: Decomposition analyses were performed on data from the Initiation of New Injectable Treatment Introduced after Antidiabetic Therapy with Oral-only Regimens (INITIATOR) study, a real-world study of patients with type 2 diabetes started on insulin glargine (GLA) or liraglutide (LIRA). These analyses investigated relative contributions of differences in baseline characteristics and treatment effects to observed differences in 1-year outcomes for reduction in glycated hemoglobin A (HbA ) and treatment persistence. RESULTS: The greater HbA reduction seen with GLA compared with LIRA (-1.39% vs. -0.74%) was primarily due to differences in baseline characteristics (HbA and endocrinologist as prescribing physician; P < 0.050). Patients with baseline HbA of 9.0% or more or evidence of diagnosis codes related to mental illness achieved greater HbA reductions with GLA, whereas patients with baseline polypharmacy (6-10 classes) or hypogylcemia achieved greater reductions with LIRA. Decomposition analyses also showed that the higher persistence seen with GLA (65% vs. 49%) was mainly caused by differences in treatment effects (P < 0.001). Patients 65 years and older, those with HbA of 9.0% or more, those taking three oral antidiabetes drugs, and those with polypharmacy of more than 10 classes had higher persistence with GLA; patients 18 to 39 years and those with HbA of 7.0% to less than 8.0% had higher persistence with LIRA. CONCLUSIONS: Although decomposition does not demonstrate causal relationships, this method could be useful for examining the source of differences in outcomes between treatments in a real-world setting and could help physicians identify patients likely to respond to a particular treatment.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hemoglobina A Glicada/metabolismo
Hipoglicemiantes/administração & dosagem
Insulina Glargina/administração & dosagem
Liraglutida/administração & dosagem
[Mh] Termos MeSH secundário: Adolescente
Adulto
Fatores Etários
Idoso
Feminino
Seres Humanos
Injeções
Masculino
Adesão à Medicação/estatística & dados numéricos
Meia-Idade
Polimedicação
Análise de Regressão
Estudos Retrospectivos
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents); 2ZM8CX04RZ (Insulin Glargine); 839I73S42A (Liraglutide)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180202
[Lr] Data última revisão:
180202
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:28953430
[Au] Autor:Wu JW; Azoulay L; Majdan A; Boivin JF; Pollak M; Suissa S
[Ad] Endereço:Jennifer W. Wu, Laurent Azoulay, Jean-François Boivin, and Samy Suissa, McGill University; Jewish General Hospital; Michael Pollak, McGill University; and Agnieszka Majdan, Jewish General Hospital, Montreal, Quebec, Canada.
[Ti] Título:Long-Term Use of Long-Acting Insulin Analogs and Breast Cancer Incidence in Women With Type 2 Diabetes.
[So] Source:J Clin Oncol;35(32):3647-3653, 2017 Nov 10.
[Is] ISSN:1527-7755
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Purpose The association between long-acting insulin analogs and increased breast cancer risk is uncertain, particularly with the short follow-up in previous studies. We assessed this risk long term in women with type 2 diabetes. Methods A population-based cohort of women 40 years or older, all of whom were treated with long-acting (glargine, detemir) or neutral protamine Hagedorn (NPH) insulin between 2002 and 2012, was formed using the United Kingdom's Clinical Practice Research Datalink. Women were followed until February 2015 or breast cancer diagnosis. Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) and 95% CIs of incident breast cancer, comparing long-acting insulin analogs with NPH overall, as well as by duration and cumulative dose. Results The cohort included 22,395 women who received insulin treatment, with 321 incident breast cancer events occurring during up to 12 years of follow-up (incidence rate 3.3 per 1,000 person-years). Compared with NPH insulin, insulin glargine was associated with an increased risk of breast cancer (HR, 1.44; 95% CI, 1.11 to 1.85), mainly increasing 5 years after glargine initiation (HR, 2.23; 95% CI, 1.32 to 3.77) and after > 30 prescriptions (HR, 2.29; 95% CI, 1.26 to 4.16). The risk was particularly elevated among prior insulin users (HR, 1.53; 95% CI, 1.10 to 2.12) but not for new users, which included fewer patients and for which one cannot rule out an HR of 1.81. The risk associated with insulin detemir was not significantly elevated (HR, 1.17; 95% CI, 0.77 to 1.77). Conclusion Long-term use of insulin glargine is associated with an increased risk of breast cancer in women with type 2 diabetes. The risk associated with insulin detemir remains uncertain because there are fewer users of this insulin.
[Mh] Termos MeSH primário: Neoplasias da Mama/epidemiologia
Diabetes Mellitus Tipo 2/complicações
Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/uso terapêutico
[Mh] Termos MeSH secundário: Idoso
Canadá
Feminino
Seres Humanos
Hipoglicemiantes/efeitos adversos
Incidência
Insulina Detemir/uso terapêutico
Insulina Glargina/uso terapêutico
Insulina Isófana/uso terapêutico
Meia-Idade
Risco
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Hypoglycemic Agents); 2ZM8CX04RZ (Insulin Glargine); 4FT78T86XV (Insulin Detemir); 53027-39-7 (Insulin, Isophane)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170928
[St] Status:MEDLINE
[do] DOI:10.1200/JCO.2017.73.4491


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[PMID]:28846865
[Au] Autor:Xu Y; Sun L; Anderson M; Bélanger P; Trinh V; Lavallée P; Kantesaria B; Marcoux MJ; Breidinger S; Bateman KP; Goykhman D; Woolf EJ
[Ad] Endereço:MRL, Department of PPDM, Regulated Bioanalysis, 770 Sumneytown Pike, WP75B-300, West Point, PA 19486, USA. Electronic address: yang_xu@merck.com.
[Ti] Título:Insulin glargine and its two active metabolites: A sensitive (16pM) and robust simultaneous hybrid assay coupling immunoaffinity purification with LC-MS/MS to support biosimilar clinical studies.
[So] Source:J Chromatogr B Analyt Technol Biomed Life Sci;1063:50-59, 2017 Sep 15.
[Is] ISSN:1873-376X
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:MK-1293 is a newly approved follow-on/biosimilar insulin glargine for the treatment of Type 1 and Type 2 diabetics. To support pivotal clinical studies during biosimilar evaluation, a sensitive, specific and robust liquid chromatography and tandem mass spectrometry (LC-MS/MS) assay for the simultaneous quantification of glargine and its two active metabolites, M1 and M2 were developed. Strategies to overcome analytical challenges, so as to optimize assay sensitivity and improve ruggedness, were evolved, resulting in a fully validated LC-MS/MS method with a lower limit of quantification (LLOQ) at 0.1ng/mL (∼16pM, equivalent to ∼2.8µU/mL) for glargine, M1 and M2, respectively, using 0.5mL of human plasma. The assay employed hybrid methodology that combined immunoaffinity purification and reversed-phase chromatography followed by electrospray-MS/MS detection operated under positive ionization mode. Stable-isotope labeled 6[D ]Leu-glargine and 4[D ]Leu-M1 were used as internal standards. With a calibration range from 0.1 to 10ng/mL, the intra-run precision (n=5) and accuracy were <6.21%, and 96.9-102.1%, while the inter-run (n=5/run for 7days) precision and accuracy were <9.55% and 96.5-105.1%, respectively, for all 3 analytes. Matrix effect, recovery, analyte stability, and interferences from control matrix, potential concomitant medications and anti-drug antibody were assessed. The assay was fully automated and has been successfully used in support of biosimilar clinical studies. Greater than 94.3% of incurred sample reanalysis (ISR) results met acceptance criteria, demonstrating the robustness of the assay. The strategic considerations during method development and validation are discussed, and can be applied to quantification of other peptides, especially insulin analogs, in the future.
[Mh] Termos MeSH primário: Cromatografia Líquida/métodos
Insulina Glargina/sangue
Insulina Glargina/metabolismo
Espectrometria de Massas em Tandem/métodos
[Mh] Termos MeSH secundário: Diabetes Mellitus Tipo 1
Estabilidade de Medicamentos
Seres Humanos
Insulina Glargina/química
Análise dos Mínimos Quadrados
Reprodutibilidade dos Testes
Sensibilidade e Especificidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
2ZM8CX04RZ (Insulin Glargine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171002
[Lr] Data última revisão:
171002
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170829
[St] Status:MEDLINE


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[PMID]:28672317
[Au] Autor:Wysham C; Bhargava A; Chaykin L; de la Rosa R; Handelsman Y; Troelsen LN; Kvist K; Norwood P
[Ad] Endereço:Rockwood Clinic, University of Washington School of Medicine, Spokane.
[Ti] Título:Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial.
[So] Source:JAMA;318(1):45-56, 2017 Jul 04.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Hypoglycemia, a serious risk for insulin-treated patients with type 2 diabetes, negatively affects glycemic control. Objective: To test whether treatment with basal insulin degludec is associated with a lower rate of hypoglycemia compared with insulin glargine U100 in patients with type 2 diabetes. Design, Setting, and Participants: Randomized, double-blind, treat-to-target crossover trial including two 32-week treatment periods, each with a 16-week titration period and a 16-week maintenance period. The trial was conducted at 152 US centers between January 2014 and December 2015 in 721 adults with type 2 diabetes and at least 1 hypoglycemia risk factor who were previously treated with basal insulin with or without oral antidiabetic drugs. Interventions: Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 361) or to receive insulin glargine U100 followed by insulin degludec (n = 360) and randomized 1:1 to morning or evening dosing within each treatment sequence. Main Outcomes and Measures: The primary end point was the rate of overall symptomatic hypoglycemic episodes (severe or blood glucose confirmed [<56 mg/dL]) during the maintenance period. Secondary end points were the rate of nocturnal symptomatic hypoglycemic episodes (severe or blood glucose confirmed, occurring between 12:01 am and 5:59 am) and the proportion of patients with severe hypoglycemia during the maintenance period. Results: Of the 721 patients randomized (mean [SD] age, 61.4 [10.5] years; 53.1% male), 580 (80.4%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 were 185.6 vs 265.4 episodes per 100 patient-years of exposure (PYE) (rate ratio = 0.70 [95% CI, 0.61-0.80]; P < .001; difference, -23.66 episodes/100 PYE [95% CI, -33.98 to -13.33]), and the proportions of patients with hypoglycemic episodes were 22.5% vs 31.6% (difference, -9.1% [95% CI, -13.1% to -5.0%]). The rates of nocturnal symptomatic hypoglycemia with insulin degludec vs insulin glargine U100 were 55.2 vs 93.6 episodes/100 PYE (rate ratio = 0.58 [95% CI, 0.46-0.74]; P < .001; difference, -7.41 episodes/100 PYE [95% CI, -11.98 to -2.85]), and the proportions of patients with hypoglycemic episodes were 9.7% vs 14.7% (difference, -5.1% [95% CI, -8.1% to -2.0%]). The proportions of patients experiencing severe hypoglycemia during the maintenance period were 1.6% (95% CI, 0.6%-2.7%) for insulin degludec vs 2.4% (95% CI, 1.1%-3.7%) for insulin glargine U100 (McNemar P = .35; risk difference, -0.8% [95% CI, -2.2% to 0.5%]). Statistically significant reductions in overall and nocturnal symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 were also seen for the full treatment period. Conclusions and Relevance: Among patients with type 2 diabetes treated with insulin and with at least 1 hypoglycemia risk factor, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemia. Trial Registration: clinicaltrials.gov Identifier: NCT02030600.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemia/prevenção & controle
Hipoglicemiantes/uso terapêutico
Insulina Glargina/uso terapêutico
Insulina de Ação Prolongada/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Glicemia/análise
Estudos Cross-Over
Diabetes Mellitus Tipo 2/sangue
Método Duplo-Cego
Feminino
Hemoglobina A Glicada/análise
Seres Humanos
Hipoglicemia/induzido quimicamente
Hipoglicemiantes/efeitos adversos
Insulina Glargina/efeitos adversos
Insulina de Ação Prolongada/efeitos adversos
Masculino
Meia-Idade
Fatores de Risco
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents); 0 (Insulin, Long-Acting); 2ZM8CX04RZ (Insulin Glargine); 54Q18076QB (insulin degludec)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170704
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.7117


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[PMID]:28672316
[Au] Autor:Lane W; Bailey TS; Gerety G; Gumprecht J; Philis-Tsimikas A; Hansen CT; Nielsen TSS; Warren M; Group Information; SWITCH 1
[Ad] Endereço:Mountain Diabetes and Endocrine Center, Asheville, North Carolina.
[Ti] Título:Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial.
[So] Source:JAMA;318(1):33-44, 2017 Jul 04.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death. Objective: To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes. Design, Setting, and Participants: Double-blind, randomized, crossover noninferiority trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period. Interventions: Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) and randomized 1:1 to morning or evening dosing within each treatment sequence. Main Outcomes and Measures: The primary end point was the rate of overall severe or blood glucose-confirmed (<56 mg/dL) symptomatic hypoglycemic episodes during the maintenance period. Secondary end points included the rate of nocturnal symptomatic hypoglycemic episodes and proportion of patients with severe hypoglycemia during the maintenance period. The noninferiority criterion for the primary end point and for the secondary end point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided statistical testing for superiority was conducted. Results: Of the 501 patients randomized (mean age, 45.9 years; 53.7% men), 395 (78.8%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia were 2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec group vs 2462.7 episodes per 100 PYE in the insulin glargine U100 group for a rate ratio (RR) of 0.89 (95% CI, 0.85-0.94; P < .001 for noninferiority; P < .001 for superiority; rate difference, -130.31 episodes per 100 PYE; 95% CI, -193.5 to -67.16). The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE in the insulin degludec group vs 428.6 episodes per 100 PYE in the insulin glargine U100 group, for an RR of 0.64 (95% CI, 0.56-0.73; P < .001 for noninferiority; P < .001 for superiority; rate difference, -61.94 episodes per 100 PYE; 95% CI, -83.85 to -40.03). A lower proportion of patients in the insulin degludec than in the insulin glargine U100 group experienced severe hypoglycemia during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI, 13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI, -10.8% to -2.7%). Conclusions and Relevance: Among patients with type 1 diabetes and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemic episodes. Trial Registration: clinicaltrials.gov Identifier: NCT02034513.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 1/tratamento farmacológico
Hipoglicemia/prevenção & controle
Hipoglicemiantes/uso terapêutico
Insulina Glargina/uso terapêutico
Insulina de Ação Prolongada/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Glicemia/análise
Estudos Cross-Over
Diabetes Mellitus Tipo 1/sangue
Método Duplo-Cego
Feminino
Hemoglobina A Glicada/análise
Seres Humanos
Hipoglicemia/induzido quimicamente
Hipoglicemiantes/efeitos adversos
Insulina Glargina/efeitos adversos
Insulina de Ação Prolongada/efeitos adversos
Masculino
Meia-Idade
Fatores de Risco
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents); 0 (Insulin, Long-Acting); 2ZM8CX04RZ (Insulin Glargine); 54Q18076QB (insulin degludec)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170704
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.7115


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[PMID]:28606095
[Au] Autor:Suzuki S; Oura T; Takeuchi M; Boye KS
[Ad] Endereço:Medicines Development Unit Japan, Eli Lilly Japan K.K, Sannomiya Plaza Bldg. 7-1-5, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan. suzuki_shuichi@lilly.com.
[Ti] Título:Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies.
[So] Source:Health Qual Life Outcomes;15(1):123, 2017 Jun 12.
[Is] ISSN:1477-7525
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Standardized patient-reported outcome (PRO) questionnaires can be utilized to evaluate treatment satisfaction (subjective evaluation of treatment) in patients with type 2 diabetes (T2D). These outcomes are important because they may affect patient adherence and overall study results. METHODS: PROs were evaluated in two randomized 26-week clinical trials in Japanese patients with T2D taking dulaglutide 0.75 mg (dulaglutide) once weekly; comparators were once-daily liraglutide (0.9 mg/day) and once-weekly placebo in one study and once-daily insulin glargine (glargine) in the other study. The Perceptions About Medications-Diabetes 21 Questionnaire - Japanese version (PAM-D21-J) and the Injectable Diabetes Medication Questionnaire - Japanese version (IDMQ-J) were completed by patients in both studies. These measures were both considered exploratory endpoints. All scale scores range from 0 to 100, with higher scores reflecting better outcomes. RESULTS: Patients reported that dulaglutide was more convenient and flexible than liraglutide (PAM-D21-J Convenience/Flexibility subscale: dulaglutide least-square mean [LSM], 84.58; liraglutide LSM, 78.94; p = .026), and that they were more satisfied with dulaglutide than with liraglutide (IDMQ-J Satisfaction subscale: dulaglutide, 75.24; liraglutide, 69.53; p = .012). Patients also reported that dulaglutide was more convenient and flexible than glargine (PAM-D21-J Convenience/Flexibility subscale: dulaglutide, 87.89; glargine, 79.22; p < .001), and that they were more satisfied with dulaglutide than with glargine (IDMQ-J Satisfaction subscale: dulaglutide, 78.86; glargine, 69.66; p < .001), and felt dulaglutide was more effective than glargine, with fewer symptoms and adverse events (PAM-D21-J Perceived Effectiveness subscale: dulaglutide, 77.61; glargine, 67.22; p < .001; Emotional Effects subscale: dulaglutide, 93.02; glargine, 89.55; p = .017; IDMQ-J Blood Glucose Control subscale: dulaglutide, 76.33; glargine, 67.57; p < .001). In addition, patients responded that dulaglutide was superior to placebo in the PAM-D21-J Convenience/Flexibility, Perceived Effectiveness, and Emotional Effects subscales and all IDMQ-J subscales (Satisfaction, Ease of Use, Lifestyle Impact, Blood Glucose Control). CONCLUSIONS: Overall, after 26 weeks of once-weekly dulaglutide administration in Japanese patients with T2D, PROs were generally positive versus the three comparator treatments (liraglutide, glargine, and placebo), suggesting increased treatment satisfaction through better blood glucose control and convenience/flexibility and reduced negative emotional effects of diabetes. TRIAL REGISTRATION: ClinicalTrials.gov (monotherapy study: NCT01558271 , registered March 12, 2012; combination therapy study: NCT01584232 , registered April 23, 2012).
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Peptídeos Semelhantes ao Glucagon/análogos & derivados
Hipoglicemiantes/uso terapêutico
Fragmentos Fc das Imunoglobulinas/uso terapêutico
Insulina Glargina/uso terapêutico
Liraglutida/uso terapêutico
Medidas de Resultados Relatados pelo Paciente
Proteínas Recombinantes de Fusão/uso terapêutico
[Mh] Termos MeSH secundário: Idoso
Esquema de Medicação
Quimioterapia Combinada
Feminino
Peptídeos Semelhantes ao Glucagon/administração & dosagem
Peptídeos Semelhantes ao Glucagon/uso terapêutico
Seres Humanos
Hipoglicemiantes/administração & dosagem
Fragmentos Fc das Imunoglobulinas/administração & dosagem
Insulina Glargina/administração & dosagem
Liraglutida/administração & dosagem
Masculino
Meia-Idade
Qualidade de Vida
Proteínas Recombinantes de Fusão/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Hypoglycemic Agents); 0 (Immunoglobulin Fc Fragments); 0 (Recombinant Fusion Proteins); 2ZM8CX04RZ (Insulin Glargine); 62340-29-8 (Glucagon-Like Peptides); 839I73S42A (Liraglutide); WTT295HSY5 (dulaglutide)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170929
[Lr] Data última revisão:
170929
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170614
[St] Status:MEDLINE
[do] DOI:10.1186/s12955-017-0696-7


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[PMID]:28605603
[Au] Autor:Marso SP; McGuire DK; Zinman B; Poulter NR; Emerson SS; Pieber TR; Pratley RE; Haahr PM; Lange M; Brown-Frandsen K; Moses A; Skibsted S; Kvist K; Buse JB; DEVOTE Study Group
[Ad] Endereço:From the Research Medical Center, Kansas City, MO (S.P.M.); University of Texas Southwestern Medical Center, Dallas (D.K.M.); Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto (B.Z.); Imperial Clinical Trials Unit, Imperial College London, London (N.R.P.);
[Ti] Título:Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes.
[So] Source:N Engl J Med;377(8):723-732, 2017 08 24.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS: We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-to-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome. RESULTS: Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P<0.001 for noninferiority). At 24 months, the mean glycated hemoglobin level was 7.5±1.2% in each group, whereas the mean fasting plasma glucose level was significantly lower in the degludec group than in the glargine group (128±56 vs. 136±57 mg per deciliter, P<0.001). Prespecified adjudicated severe hypoglycemia occurred in 187 patients (4.9%) in the degludec group and in 252 (6.6%) in the glargine group, for an absolute difference of 1.7 percentage points (rate ratio, 0.60; P<0.001 for superiority; odds ratio, 0.73; P<0.001 for superiority). Rates of adverse events did not differ between the two groups. CONCLUSIONS: Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine with respect to the incidence of major cardiovascular events. (Funded by Novo Nordisk and others; DEVOTE ClinicalTrials.gov number, NCT01959529 .).
[Mh] Termos MeSH primário: Doenças Cardiovasculares/induzido quimicamente
Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/efeitos adversos
Insulina Glargina/efeitos adversos
Insulina de Ação Prolongada/efeitos adversos
[Mh] Termos MeSH secundário: Idoso
Glicemia/análise
Doenças Cardiovasculares/epidemiologia
Diabetes Mellitus Tipo 2/sangue
Diabetes Mellitus Tipo 2/complicações
Método Duplo-Cego
Feminino
Seres Humanos
Hipoglicemia/induzido quimicamente
Hipoglicemiantes/uso terapêutico
Incidência
Insulina Glargina/uso terapêutico
Insulina de Ação Prolongada/uso terapêutico
Estimativa de Kaplan-Meier
Masculino
Meia-Idade
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Hypoglycemic Agents); 0 (Insulin, Long-Acting); 2ZM8CX04RZ (Insulin Glargine); 54Q18076QB (insulin degludec)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170613
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1615692


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[PMID]:28475455
[Au] Autor:Reid TS; Schafer F; Brusko C
[Ad] Endereço:a Mercy Diabetes Center , Janesville , WI , USA.
[Ti] Título:Higher concentration insulins: an overview of clinical considerations.
[So] Source:Postgrad Med;129(5):554-562, 2017 Jun.
[Is] ISSN:1941-9260
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Three higher concentration insulin products (insulin lispro 200 units/mL, insulin degludec 200 units/mL, and insulin glargine 300 units/mL) received US Food and Drug Administration (FDA) approval in 2015. Although human regular insulin 500 units/mL (U-500) was approved in 1997, a pen and dedicated U-500 syringe became available in 2016. These products offer more treatment options for the increasing numbers of patients requiring insulin to achieve and maintain glycemic targets. Higher concentration insulins have some unique safety and efficacy considerations. Important considerations when transitioning patients from the 100 unit/mL concentration (U-100) to the higher concentration include bioequivalence, pen dose increments, and pen appearance. Bioequivalent insulins have similar pharmacokinetic properties and no dose adjustments are expected when transitioning from the U-100 to the higher concentration. In contrast, higher concentration insulins with different pharmacokinetic and pharmacodynamic properties compared with the U-100 formulation may require dose adjustments. In order to provide safe and effective therapy to patients with higher daily insulin dose requirements, it is important for healthcare professionals to become very familiar with the characteristics of and differences between each of the higher concentration insulins. This paper highlights differences between the U-100 and higher concentration insulins and focuses on practical aspects of use.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/química
Hipoglicemiantes/uso terapêutico
Insulinas/química
Insulinas/uso terapêutico
[Mh] Termos MeSH secundário: Seres Humanos
Hipoglicemiantes/administração & dosagem
Insulina Glargina
Insulina Lispro
Insulina de Ação Prolongada
Insulinas/administração & dosagem
Equivalência Terapêutica
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Hypoglycemic Agents); 0 (Insulin Lispro); 0 (Insulin, Long-Acting); 0 (Insulins); 2ZM8CX04RZ (Insulin Glargine); 54Q18076QB (insulin degludec)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170619
[Lr] Data última revisão:
170619
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170506
[St] Status:MEDLINE
[do] DOI:10.1080/00325481.2017.1325311



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