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Tecnologia: Insulinas análogas de liberação prolongada versus insulina NPH (protamina neutra de Hagedorn). Indicação: Tratamento de adultos com diabetes mellitus tipo 2. Pergunta: Há diferenças de efeito nos principais desfechos de eficácia e segurança entre insulinas análogas de liberação prolongada versus insulina NPH no tratamento de pacientes com DM2? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foi selecionada e incluída uma revisão sistemática. Conclusão: As insulinas análogas (glargina e detemir) não demonstraram superioridade nos desfechos de eficácia e segurança quando comparadas à insulina NPH, não demonstraram redução significativa em relação à mortalidade por todas as causas e complicações secundárias ao DM2. Quando comparadas à insulina NPH, foi observado redução na hipoglicemia confirmada e hipoglicemia noturna a favor das insulinas análogas e na hipoglicemia grave a favor da insulina detemir
Technology: Long-acting insulin analogues versus NPH insulin (human isophane insulin). Indication: Treatment of adults with type 2 diabetes mellitus. Question: Are there effect differences in key efficacy and safety outcomes between long-acting insulin analogues versus NPH insulin in the treatment of DM2 patients? Methods: Rapid review of evidence (overview) of systematic reviews, with a bibliographic survey carried out in the PUBMED database, using a structured search strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Results: A systematic review was selected and included. Conclusion: Analog insulins (glargine and detemir) did not demonstrate superiority in efficacy and safety outcomes when compared to NPH insulin, did not demonstrate a significant reduction in all-cause mortality and complications secondary to DM2. When compared to NPH insulin, a reduction in confirmed hypoglycemia and nocturnal hypoglycemia in favor of analogue insulins and in severe hypoglycemia in favor of insulin detemir was observed
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Diabetes Mellitus, Type 2/drug therapy , Insulin Detemir/therapeutic use , Insulin Glargine/therapeutic use , Insulin, Isophane/therapeutic use , Comparative Effectiveness Research , Hypoglycemia/complicationsABSTRACT
Insulin analogues can reduce gestational hyperglycemia more safely and effectively because their molecular structure and metabolic characteristics are more consistent with the characteristics of gestational glucose metabolism. However, the safety and effectiveness of some insulin analogues in pregnancy remain unclear. At present, only a few insulin analogues, insulin aspart, insulin lispro and insulin detemir, have been approved for use during pregnancy in China. As for misuse or off-label insulin analogues during pregnancy, clinicians should make adjustments based on published clinical safety data. In this review, the safety and progress in the management of gestational hyperglycemia with rapid- and long-acting insulin analogues and insulin degludec/insulin aspart are reviewed to provide reference for insulin therapy during pregnancy.
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Diabetes is a kind of worldwide chronic disease with high incidence,which threatens people's lives and work.With the development of DNA recombination technology,long-acting basal insulin analogues bring gospel and hope for patients with diabetes.Insulin glargine (IGla),detemir (IDet) and degludec (IDeg),as three basic types of insulin,commonly used in clinical practice that slowly absorbed and distributed by changing the structure,and relatively long acting time,more fit the physiological model of insulin secretion.Therefore,the existing studies of molecular structure,long-acting mechanism,safety evaluation and pharmacodynamic effects of three kinds of insulin preparations are briefly summarized.
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OBJECTIVE:To systematically review the efficacy and safety of insulin glargine versus insulin detemir in the treat-ment of type 2 diabetes,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from PubMed,EM-Base,Cochrane Library,CBM,CJFD,VIP and Wanfang database,randomized controlled trials (RCT) about the clinical efficacy and safety of insulin glargine versus insulin detemir in the treatment of type 2 diabetes were collected. Meta-analysis was performed by using Rev Man 5.2 software after data extraction and quality evaluation by Cochrane 5.1.0. RESULTS:A total of 18 RCTs,in-volving 3 638 patients were included. Results of Meta-analysis showed there was no significant difference in reducing glycosylated hemoglobin[MD=0.08,95%CI (-0.01,0.17),P=0.09];fasting blood glucose level in insulin glargine group was significantly lower thaninsulin detemir,the difference was statistically significant [MD=0.15,95%CI(0.03,0.27),P=0.02]. And there was no significant difference in the incidence of hypoglycemia [OR=0.97,95%CI(0.91,1.03),P=0.25];the degree of body mass gain ininsulin detemir was significantly lower than insulin glargine group [MD=-0.95,95%CI(-1.06,-0.85),P=0.003],but the in-cidence of injection site reactions was significantly higher than insulin glargine group [OR=2.28,95%CI(1.16,4.50),P=0.02],the differences were statistically significant. CONCLUSIONS:The insulin glargine has better efficacy,than insulin detemir with lower incidence of injection site reactions but higher degree of body mass gain than insulin detemir in the treatment of type 2 diabetes.
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Objective To explore modification of islet cell function in type 2 diabetes by the treatment of insulin detemir and insulin aspart.Methods A total of 68 patients with diagnosed type 2 diabetes were randomized into two grouops,the control group (insulin glargine combined with insulin aspart)and observation group (insulin detemir combined with insulin aspart),each group had 34 cases.Before and after treatment,fasting insulin and 2 h postprandial insulin,glycated hemoglobin (HbA1c),C peptide and fructosamine (FMN)levels were compared in two groups,and the treatment safety was observed.Results After treatment,fasting insulin and C -peptide levels in the two groups were significantly increased than before treatment(P 0.05).In the observation group,except for 2h postprandial insulin levels,other indicators had no significant differences compared with the control group (P >0.05 ).After treatment,FMN and HbA1c in the two groups decreased significantly compared with before treatment(P 0.05).During treatment,both two groups observed hypoglycemia,but there were no severe adverse reactions.Conclusion The clinical application of insulin detemir combined with insulin aspart in the treatment of type 2 diabetes can significantly improve the insulin -producing cells and accelerate functional recovery, and the clinical effect is better than the united aspart insulin glargine,with no significant adverse reactions,it can be recommended as a clinical type 2 diabetes treatment drug of choice.
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[Summary] Poorly controlled hyperglycemia is closely associated with adverse outcomes during pregnancy. As the prevalence of diabetes rapidly increases ,the management of diabetes during pregnancy has been a significant and urgent need in clinical practice. This article reviewed the hot spots in the research field of gestational diabetes mellitus (GDM ) and pregnancy with diabetes mellitus ,including progresses on the risk factors for GDM and the long term effects of diabetes during pregnancy on mothers and offspring. This was followed by a body of evidences on the clinical benefits of improved glycemic control during pregnancy ,current therapeutic strategy using insulin as the golden standard as well as the potential advantage of insulin determir due to its unique pharmacokinetic‐pharmacodynamic (PK‐PD ) profile in this therapeutic area. Finally ,the authors summarized data from clinical trials on the usage of insulin detemir in pregnancy and in particular went over the designs and results of two randomly controlled trials investigating the efficacy and safety of insulin detemir in pregnancy patients with T1DM. Currently available data proved that insulin detemir was effective in improving glycemic control with a good safety profile in diabetic pregnant patients ,which may serve as an ideal choice in the management of diabetes during pregnancy.
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Objective To observe the clinical efficacy of different kinds of insulin combined with Metformin in the treatment of T2DM.Methods 120 T2DM patients were selected and divided into three groups according to different therapies of reducing blood sugar with 40 cases in each group.Group A was treated with insulin glargine combined with Metformin;Group B with insulin detemir combined with Metformin and Group C with protamine zinc insulin combined with Metformin .The time for reaching the standards of blood sugar and the corresponding usage amount of insulin of three groups were observed;After 6 months, the three groups were com-pared in terms of FBG, PBG HbA1c, HOMA-IR, TC, TG and LDL-C.Meanwhile, the incidence rate of hypoglycemia after treat-ment was observed.Results Time for reaching the standards of blood sugar in Group A, Group B and Group C was (6.9 ±2.3)d, (4.1 ±3.0)d and (3.8 ±1.5)d, respectively;the corresponding dosages of insulin of the three groups was (19.0 ±7.8)U, (12.1 ±5.9)U and (11.9 ±5.3)U, respectively, with significant difference between Group A and Groups C, D (p0.05).After 6 months, FBG, PBG, HbA1c, HOMA-IR in Group B, Group C and Group A were significantly reduced (p0.05).6 months follow-ing the treatment, TC, TG and LDL-C in Group B, Group C and Group A were significantly different (p0.05).Conclusion The insulin detemir and protamine zinc insulin com-bined with Metformin has a better clinical efficacy in the treatment of T2DM.It can promptly control the blood sugar level and lead to a lower incidence rate of hypoglycemia.Therefore it is worthy of promotion.
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Insulin detemir is a long-acting basal insulin analogue recently introduced in veterinary medicine for treatment of canine diabetes mellitus. As there are only limited studies in dogs, long-term evaluation of insulin detemir in veterinary medicine is required. In this study, we investigated trends in12-hour blood glucose concentration during hospitalization and evaluated initial and following doses of insulin detemir for several months in six diabetic dogs. The mean levels of blood glucose over 12-hour periods were between 113.5 to 327.2 mg/dL, and the average glucose nadir was 103 mg/dL in the six dogs. The dogs were treated with a mean dosage of 0.24 U/kg of insulin detemir, but hypoglycemia was observed in four of the dogs at the first monthly follow-up. Thus, insulin doses were adjusted according to the nadir levels of glucose observed during the follow-up periods (range, 1 to 16 months). The total range of insulin doses throughout the study period was between 0.1 and 0.4 U/kg. Changes in insulin doses in each dog during the follow-up period were not variable. We suggest that insulin detemir might be not only an alternative choice against traditional insulin for patients with insulin resistance or concurrent disease but also an effective home therapy medication in canine patients with DM. This study could help inform veterinary practitioners regarding the use of insulin detemir for canine insulin-dependent DM.
Subject(s)
Animals , Dogs , Humans , Adrenocortical Hyperfunction , Blood Glucose , Diabetes Mellitus , Diabetic Ketoacidosis , Follow-Up Studies , Glucose , Hospitalization , Hypoglycemia , Insulin Resistance , Insulin , Insulin Detemir , Veterinary MedicineABSTRACT
Objetivo: Analizar la costo-efectividad del uso de Detemir frente a otras insulinas (Glargine e NPH) para tratamiento de diabetes tipo 2 en Colombia. Métodos: Mediante un modelo deMarkov se analizó la costo-efectividad desde la perspectiva del tercero pagador, en una cohorte de 10000 personas de 45 años, en un horizonte temporal de 5 años. Como desenlaces se evaluaron eventos cardiovasculares y muertes evitadas -medidas en Años de Vida Salvados (AVS)- relacionadas con eventos de hipoglicemia severa. Los costos se tomaron de bases de datos de prestadores de servicios de salud a precios 2013. Se utilizó una tasa de descuento del 3% para costos y resultados. Se aplicó un análisis de sensibilidad para comprobar la robustez del modelo. Resultados: Detemir presentó un menor número de eventos de hipoglicemia severa (730) frente a Glargine (1.910) y NPH (2.140), y un menor número de eventos macrovasculares (1.053) y microvasculares (1.019) frente a Glargine (1.116,1.037, respectivamente) y NPH (1.129 y 1.042, respectivamente). Detemir evitó 122 y 147 muertes frente a Glargine y NPH, respectivamente, equivalentes a 4.233 y 3.513 AVS, respectivamente. Tras el descuento el ICER por AVS con Detemir frente a Glargine fue de USD $ 998,39 y frente a NPH fue de USD $4.096,86. En el análisis de sensibilidad tipo Montecarlo, Detemir se mantiene costo-efectivo en el 100% de los casos, según el umbral propuesto por la OMS. Conclusiones: Detemir, desde la perspectiva del tercero pagador, es costo-efectivo frente a Glargine y NPH para tratamiento de diabetes tipo 2 en Colombia.
Objective: Analyze the cost-effectiveness of using Detemir versus using other insulins (Glargine and NPH insulin) for treatment of type 2 diabetes in Colombia. Methods: A Markov model was used to evaluate cost-effectiveness of Determir from a third-party payer's perspective in a hypothetical cohort of 10,000 patients, aged 45 years, with type 2 diabetes in risk of cardiovascular events and death in a 5-year time horizon. Both cardiovascular events and deaths avoided -expressed in Life-Year Saved- related to severe hypoglycemia events were considered as outcomes. Costs were obtained from health care providers databases at 2013 prices. A discount rate of 3% was applied to costs and outcomes. A sensitivity analysis was conducted to test the robustness of the model. Results: In the model, using Detemir has fewer numbers of severe hypoglycemic events (730) versus NPH insulin (1,910) and Glargine (2,140), and fewer number of macrovas-cular (1,053) and microvascular (1,019) events versus Glargine (1,116; 1,037) and NPH (1,129; 1,042). Using Detemir, 122 and 147 deaths were avoided compared to Glargine and NPH respectively; those figures are respectively equivalent to 4,233and 3,513 Life-Year Saved. As discount was applied the ICER per Life-Year Saved for Detemir versus Glargine was US$ 998.39 and USD 4,096.86 against NPHinsulin. In the Montecarlo sen-sitivity analysis Detemir remains cost effective in 100% of cases according to the WHO-proposed threshold. Conclusion: From a third-party payer's perspective,Detemir is cost-effective compared to Glargine and NPH insulin for treatment of type 2 diabetes in Colombia.
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Objective To observe the clinical effect by using insulin detemir therapy in children and adolescents with type 1 diabetes mellitus(T1DM).Methods Thirty children and adolescents with T1DM were divided into 2 groups to receive Humulin R and Determir(observation group,n =15) or Humulin R and neutral protamine hagedorn (NPH) (control group,n =15)insulin therapy.Daily insulin dose,glycemic variability,incidence of non-severe and severe hypoglycemia events after the institution of insulin therapy were collected.Results The daily doses of insulin were (1.16 ± 0.30) U/kg in the observation group and(1.21 ± 0.35) U/kg in the control group,respectively.There was no clinically important change between 2 groups(t =0.526,P ＞ 0.05).Within-subject variation in fasting plasma glucose was significantly lower in observation group(29％)than that in control group(65％) (t =5.296,P ＜0.01).One case of severe hypoglycemia event occurred in the observation group,but 5 cases occurred in the control group(t =4.863,P ＜ 0.0l).Two cases of nocturnal hypoglycaemia(22:00-7:00) events occurred in the observation group,7 cases occurred in the control group(t =4.506,P ＜ 0.01).Conclusions Institution of insulin detemir therapy is associated with low within-subject variation in fasting plasma glucose and decreased rates of severe and nocturnal hypoglycemia while dose of insulin did not increase.This makes insulin detemir a valuable new tool for the treatment of children and adolescents with T1 DM.
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Pregnancy affects both maternal and fetal metabolism, and even in non-diabetic women, it exerts a diabetogenic effect. Among pregnant women, 2% to 14% develop gestational diabetes. Pregnancy can also occur in women with preexisting diabetes, which may predispose the fetus to many alterations in organogenesis, restrict growth, and the mother, to some diabetes-related complications, such as retinopathy and nephropathy, or to acceleration of the course of these complications, if they are already present. Women with gestational diabetes generally start their treatment with diet and lifestyle changes; when these changes are not enough for optimal glycemic control, insulin therapy must then be considered. Women with type 2 diabetes using oral hypoglycemic agents are advised to change to insulin therapy. Those with preexisting type 1 diabetes should start intensive glycemic control. As basal insulin analogues have frequently been used off-label in pregnant women, there is a need to evaluate their safety and efficacy. The aim of this review is to report the use of both short- and long-acting insulin analogues during pregnancy and to enable clinicians, obstetricians, and endocrinologists to choose the best insulin treatment for their patients.
A gravidez afeta tanto o metabolismo materno quanto o fetal e, mesmo em mulheres não diabéticas, apresenta um efeito diabetogênico. Entre as mulheres grávidas, 2% a 14% desenvolvem o diabetes gestacional. A gravidez pode ocorrer também em mulheres já diabéticas, o que pode predispor o feto a muitas alterações na organogênese, restrição de crescimento e a mãe a algumas complicações relacionadas ao diabetes, tais como retinopatia e nefropatia, ou acelerar o curso dessas complicações se já estiverem presentes. Pacientes com diabetes gestacional geralmente iniciam seu tratamento com dieta e mudanças no estilo de vida; porém, quando essas medidas falham em atingir um controle glicêmico adequado, a insulinoterapia deve ser considerada. Pacientes com diabetes tipo 2 em uso de hipoglicemiantes orais são aconselhadas a iniciar o uso de insulina. Pacientes com diabetes tipo 1 preexistente devem iniciar um controle glicêmico estrito. Em função do fato de os análogos basais de insulina estarem sendo utilizados muito frequentemente off-label em pacientes grávidas, faz-se necessário avaliar sua segurança e eficácia nessa condição. O objetivo desta revisão é avaliar o uso de tais análogos, tanto de ação curta como prolongada, durante a gravidez, para possibilitar médicos clínicos, obstetras e endocrinologistas escolher o melhor regime terapêutico para suas pacientes.
Subject(s)
Female , Humans , Pregnancy , Diabetes Mellitus, Type 1/drug therapy , /drug therapy , Hypoglycemic Agents/therapeutic use , Insulin, Long-Acting/therapeutic use , Insulin, Short-Acting/therapeutic use , Pregnancy in Diabetics/drug therapy , Blood Glucose/metabolismABSTRACT
There have appeared many new insulin analogues in recently years. Two of them are rapid-acting insulin analogues(aspart,lispro).The regions between the insulin analog molecules were modified,which have shorter time than regular human insulin in onset of action,peak,duration of acting,and are better in decreasing postprandial glucose and opportunity of hypoglycemia before next meal.The another insulin analogues were galargine and detemir.They were obtained from changing insulin isoelectric point and increasing molecular weight,which lengthen time for disintegration,absorption and action and have little absorption variation and no overt peak.They can simulate physiological base insulin excretion.