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1.
Diabetes Obes Metab ; 24(4): 684-692, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34957654

RESUMO

AIM: To investigate whether upper gastrointestinal (GI) disease has any effect on the exposure of oral semaglutide, an important consideration given that its absorption occurs primarily in the stomach. MATERIALS AND METHODS: In an open-label, parallel-group trial (NCT02877355), subjects aged 18-80 years with type 2 diabetes with mild-to-moderate upper GI disease (N = 36; chronic gastritis [n = 5], gastroesophageal reflux disease [n = 8], and both [n = 23]) or without upper GI disease (N = 19) received oral semaglutide 3 mg once daily for 5 days, followed by 7 mg for 5 days. The primary and key supportive endpoints were the area under the semaglutide plasma concentration-time curve (AUC) from 0 to 24 hours after last trial product administration on day 10 (AUC0-24h,day10 ) and the maximum semaglutide plasma concentration (Cmax,day10 ), respectively. RESULTS: Semaglutide exposure was not statistically significantly different between subjects with and without upper GI disease. Estimated group ratios (subjects with/without upper GI disease) were 1.18 (95% confidence interval [CI], 0.80, 1.75) for AUC0-24h,day10 and 1.16 (95% CI, 0.77, 1.76) for Cmax . Time to Cmax and semaglutide half-life were similar in subjects with and without upper GI disease. Oral semaglutide was well tolerated; all adverse events were mild-to-moderate, with no withdrawals because of adverse events. CONCLUSIONS: There was no significant difference in exposure to oral semaglutide in subjects with or without upper GI disease, hence no dose adjustment is required.


Assuntos
Diabetes Mellitus Tipo 2 , Gastroenteropatias , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/induzido quimicamente , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Gastroenteropatias/induzido quimicamente , Gastroenteropatias/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon , Humanos , Hipoglicemiantes , Pessoa de Meia-Idade , Adulto Jovem
2.
Medicine (Baltimore) ; 101(17): e29154, 2022 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-35512071

RESUMO

BACKGROUND: Dipeptidyl-peptidase IV inhibitor (DPP-4i) is a common hypoglycemic medication in treating type 2 diabetes millitus. It has become widely utilized in clinical practice due to its ability to effectively manage blood glucose while posing a low risk of hypoglycemia and weight gain. However, there is no consensus on DPP-4i's pancreatic safety due to a paucity of clinical evidence. The safe event appears to be easily overlooked. This review aims to evaluate the pancreatic safety of DPP-4i in patients with type 2 diabetes mellitus using the standard pairwise and network meta-analysis methods. METHODS: MEDLINE, Embase, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials will be used to search for published literature on the pancreatic safety of DPP-4 inhibitors in type 2 diabetes millitus, and clinical trial registries will be used to look for unpublished trials. Two independent reviewers will screen literature for eligibility, extract available data, and assess the risk of bias. All divergences will be resolved after rechecking the source papers and further discussion among the reviewers with a complete consensus before inclusion. The risk of bias will be assessed by the Cochrane bias risk tool, and the quality of evidence will be interpreted by the GRADE Working Group approach. We will use STATA16.0 and WinBUGS1.4.3 for paired meta-analysis and Bayesian network meta-analysis. RESULTS: This study will evaluate the pancreatic safety of DPP-4 inhibitors in type 2 diabetes millitus. CONCLUSION: This systematic review and network meta-analysis will evaluate the pancreatic safety of DPP-4i in patients with type 2 diabetes millitus. The findings of this study may supplement the evidence-based information on DPP-4i, improve existing understanding of this issue, and assist patients and clinicians in making better treatment decisions by raising their awareness of the problem. PROTOCOL REGISTRATION NUMBER: INPLASY202230014.


Assuntos
Diabetes Mellitus Tipo 2 , Inibidores da Dipeptidil Peptidase IV , Teorema de Bayes , Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Humanos , Hipoglicemiantes/efeitos adversos , Metanálise como Assunto , Metanálise em Rede , Revisões Sistemáticas como Assunto
3.
Diab Vasc Dis Res ; 19(3): 14791641221093175, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35543342

RESUMO

OBJECTIVE: To compare clinical outcomes in diabetic patients with heart failure managed by insulin with those managed by non-insulin (oral hypoglycemic agents and/or lifestyle modification) based therapy. METHODS: PubMed and Scopus databases were searched for studies conducted on diabetic patients with heart failure. Studies were to compare outcomes of patients managed by insulin versus non-insulin therapies. RESULTS: 15 studies were included. Compared to those who were managed using non-insulin therapy, insulin-treated patients had increased risk of all-cause mortality (RR 1.46, 95% CI: 1.14, 1.88) and cardiovascular specific mortality (RR 1.62, 95% CI: 1.33, 1.96). Those managed using insulin also had increased risk of hospitalization (RR 1.45, 95% CI: 1.09, 1.93) and readmission (RR 1.49, 95% CI: 1.32, 1.67). There was no additional risk for stroke (RR 1.07, 95% CI: 0.91, 1.27) or myocardial infarction (MI) (RR 1.10, 95% CI: 0.96, 1.27) between the two groups of patients. CONCLUSIONS: Receipt of insulin among diabetic patients with heart failure was associated with an increased risk of mortality, hospitalization and readmission compared to management using oral hypoglycemic agents and/or lifestyle modification. Such patients should be closely monitored for any adverse events.


Assuntos
Diabetes Mellitus , Insuficiência Cardíaca , Infarto do Miocárdio , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Infarto do Miocárdio/tratamento farmacológico
4.
Artigo em Inglês | MEDLINE | ID: mdl-35504696

RESUMO

INTRODUCTION: We investigated trends in the proportion of diabetes treatment and glycemic control, which may be altered by recent advances in insulin and non-insulin drugs, in Japanese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A serial cross-sectional study was performed using a multicenter large-population database from the Japan Diabetes Clinical Data Management study group. Patients with type 2 diabetes who attended clinics belonging to the study group between 2002 and 2018 were included to examine trends in glycated hemoglobin A1c (HbA1c) by treatment group using multivariable non-linear regression model. RESULTS: The proportion of patients with insulin only decreased from 15.0% to 3.6%, patients with insulin+non-insulin drugs increased from 8.1% to 15.1%, patients with non-insulin drugs increased from 50.8% to 67.0%, and those with no drugs decreased from 26.1% to 14.4% from 2002 to 2018, respectively. The HbA1c levels of each group, except for no drugs, continued to decrease until 2014 (unadjusted mean HbA1c (%) from 2002 to 2014: from 7.89 to 7.45 for insulin only, from 8.09 to 7.63 for insulin+non-insulin, and from 7.51 to 6.98 for non-insulin) and remained unchanged thereafter. Among insulin-treated patients, use of human insulin decreased, use of long-acting analog insulin increased, and concomitant use of non-insulin drugs increased (from 35.1% in 2002 to 80.9% in 2018), which included increased use of dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and glucagon-like peptide 1 receptor agonists, and the persistently high use of metformin. CONCLUSIONS: During the past two decades, combined use of insulin and non-insulin drugs increased and glycemic control improved and leveled off after 2014 in Japanese patients with type 2 diabetes. Further studies of the trend in association with age and factors related to metabolic syndrome are necessary to investigate strategies aiming at personalized medicine in diabetes care.


Assuntos
Diabetes Mellitus Tipo 2 , Insulina , Estudos Transversais , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Hemoglobina A Glicada/análise , Controle Glicêmico , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Insulina Regular Humana , Japão/epidemiologia
5.
BMC Nephrol ; 23(1): 174, 2022 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-35524187

RESUMO

INTRODUCTION: Metformin-associated lactic acidosis (MALA) is a rare but life-threatening condition. Here, we report the outcome of a patient with MALA complicated by acute coronary syndrome. CASE PRESENTATION: A 47-year-old obese woman of Caucasian ethnicity was admitted for syncope and tachypnea with Kussmaul breathing. She had a type-2 diabetes and was on oral antidiabetic therapy. Hemoglobin A1c was 6.6%. On admission, a severe acute kidney injury (serum creatinine: 1251 µmol/L) with hyperkalemia (7.5 mmol/L) and severe lactic acidosis (ph:7.042, bicarbonate: 9.9 mmol/L, partial pressure of carbon dioxide: 21.8 mmHg, lactate: 20.0 mmol/L) was found. Despite bicarbonate therapy, ph further decreased. Within 2.5 h of admission, a temporary hemodialysis catheter was placed, and one session of a high-efficiency hemodialysis was performed. 8 h after admission, a continuous venovenous hemodiafiltration was initiated and maintained for 2 days. The metformin therapy was stopped. Supplemental oxygen, intravenous catecholamines (4 days) and antibiotic therapy (7 days) were applied. During this therapy of lactic acidosis, an acute coronary syndrome evolved by day 2 after admission and resolved by day 5 in hospital. After recovery, the patient was transferred to a general ward on day 7 and left the hospital on day 11. By discharge, both the acute kidney injury and the acute coronary syndrome were reversible. CONCLUSION: In the patient with MALA complicated by acute coronary syndrome, the combination of a high-efficiency hemodialysis and, consecutively, continuous venovenous hemodiafiltration led to a favorable outcome.


Assuntos
Acidose Láctica , Síndrome Coronariana Aguda , Injúria Renal Aguda , Diabetes Mellitus Tipo 2 , Metformina , Acidose Láctica/induzido quimicamente , Acidose Láctica/terapia , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/terapia , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/terapia , Bicarbonatos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade
7.
Prim Care ; 49(2): 213-223, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35595478

RESUMO

Assessing glycemia over time remains a standard recommendation in the care of all people with diabetes. Glycemic assessment methods range from laboratory- and office-based methods to patient-based methods. Assessing A1c has long been the most common method of assessing overall glycemia. Continuous glucose monitoring (CGM) can also be used, especially via glucose management indicator or time-in-range, which can be useful especially when A1c might be impractical, unreliable, or inaccurate, or for glycemia assessment over a shorter interval. Other measures of glycemia, including hypoglycemia and glycemic variability, are becoming increasingly important in many cases and are also available via CGM.


Assuntos
Glicemia , Hipoglicemia , Automonitorização da Glicemia/métodos , Glucose , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/diagnóstico , Hipoglicemiantes/uso terapêutico
8.
Prim Care ; 49(2): 255-273, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35595481

RESUMO

Because macrovascular complications of diabetes are the leading cause of mortality and decreased quality of life for individuals with diabetes, prevention and risk reduction are paramount. Besides lifestyle management, contemporary therapies can significantly reduce risk for cardiovascular events in diabetes. For primary prevention, most individuals should be on statin therapy, whereas those at high atherosclerotic cardiovascular disease risk should also be on glucagon-like peptide 1 receptor agonists (GLP1RA) or sodium/glucose cotransporter-2 inhibitors (SGLT2i) at any hemoglobin A1c. For secondary prevention, addition of GLP1RA or SGLT2i, PCKS9i, rivaroxaban, and/or icosapent ethyl should be considered in addition to a statin and low-dose aspirin.


Assuntos
Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Inibidores de Hidroximetilglutaril-CoA Redutases , Inibidores do Transportador 2 de Sódio-Glicose , Doenças Cardiovasculares/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Receptor do Peptídeo Semelhante ao Glucagon 1/uso terapêutico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipoglicemiantes/uso terapêutico , Qualidade de Vida , Inibidores do Transportador 2 de Sódio-Glicose/farmacologia , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico
9.
Prim Care ; 49(2): 287-300, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35595483

RESUMO

The incidence of all diabetes types are increasing, including the rate of women with diabetes in pregnancy. Preconception counseling continues to be an important part of visits with women who have diabetes and those at risk for gestational diabetes. Intensive control of blood sugar reduces the risk of negative outcomes in mother and baby. Diet and insulin are the preferred treatments for diabetes in pregnancy. While metformin has shown benefits in pregnancy, its use is debated. Insulin dose adjustments are required to reach glycemic goals during pregnancy and tend to change throughout its course with higher doses needed with increasing insulin resistance in the second and third trimesters. Breastfeeding is encouraged for all women regardless of diabetes type. Insulin doses generally need adjustment after delivery due to placental delivery leading to decreased insulin and lactation increasing energy requirements.


Assuntos
Diabetes Gestacional , Hipoglicemiantes , Glicemia , Diabetes Gestacional/tratamento farmacológico , Feminino , Humanos , Insulina , Placenta , Período Pós-Parto , Gravidez
10.
Prim Care ; 49(2): 301-313, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35595484

RESUMO

Insulin is an important treatment in diabetes, and understanding insulin pharmacokinetics is vital to clinical practice. The primary care physician should be knowledgeable about the decision for use, initiation of treatment and titration as well as common pitfalls such as hypoglycemia and cost.


Assuntos
Diabetes Mellitus Tipo 2 , Insulina , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico
11.
Prim Care ; 49(2): 315-326, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35595485

RESUMO

The landscape of diabetes treatment has evolved significantly in recent years. While metformin remains first-line for the treatment of type 2 diabetes, 2 new classes of medications (sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide agonists) are becoming mainstays in therapy. These classes boast strong efficacy and desired long-term outcomes, offering cardiovascular and renal protection, as well as other benefits such as weight loss and low risk of hypoglycemia. Most recent guidelines have highlighted the importance of using shared decision making and patient-centered choices when determining medication outcomes.


Assuntos
Diabetes Mellitus Tipo 2 , Metformina , Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/uso terapêutico , Humanos , Hipoglicemiantes/farmacologia , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Perda de Peso
12.
Prim Care ; 49(2): 327-337, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35595486

RESUMO

The management of diabetes in clinical practice has many challenges: quickly interpreting a large volume of self-monitoring of blood glucose data, ensuring safe and accurate titration of basal insulin, managing patients on insulin pump therapy, and synthesizing glycemic data into actionable reports to improve patient outcomes. Technological advancements are emerging as a solution to some of these challenges. This article reviews mobile applications for insulin dosing, continuous glucose monitoring, insulin pump therapy, and smart insulin pens available for patients with type 1 and type 2 diabetes.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Tecnologia
14.
Cardiovasc Diabetol ; 21(1): 79, 2022 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-35596173

RESUMO

BACKGROUND: In patients with type 2 diabetes mellitus (T2DM) an association between severe hypoglycaemic episodes and the risk of cardiovascular (CV) morbidity and mortality has been previously established. METHODS: We aimed to investigate the influence of hypoglycaemia on several diabetes-related and platelet-related miRNAs selected based on bioinformatic analysis and literature search, including hsa-miR-16, hsa-miR-34a, hsa-miR-129-2, hsa-miR-15a, hsa-miR-15b, hsa-miR-106a, miR-223, miR-126. Selected miRNAs were validated by qRT-PCR in 14 patients with T2DM on metformin monotherapy, without established CV disease and antiplatelet therapy during a stepwise hypoglycaemic clamp experiment and a follow-up 7 days after the clamp event. In order to identify which pathways and phenotypes are associated with validated miRNAs we performed target prediction on genes expressed with high confidence in platelets. RESULTS: Circulating levels of miR-106a-5p, miR-15b, miR-15a, miR-16-5p, miR-223 and miR-126 were increased after euglycaemic clamp followed by hypoglycaemic clamp, each with its distinctive time trend. On the contrary, miR-129-2-3p, miR-92a-3p and miR-34a-3p remained unchanged. MiR-16-5p was negatively correlated with interleukin (IL)-6, intercellular adhesion molecule (ICAM) and vascular cell adhesion molecule (VCAM) (p = 0.002, p < 0.001, p = 0.016, respectively), whereas miR-126 was positively correlated with VCAM (p < 0.001). There were negative correlations between miR-16-5p, miR-126 and coagulation factors, including factor VIII and von Willebrand factor (vWF). Among all studied miRNAs, miR-126, miR-129-2-3p and miR-15b showed correlation with platelet function. Bioinformatic analysis of platelet-related targets of analyzed miRNAs showed strong enrichment of IL-2 signaling. We also observed significant enrichment of pathways and diseases related to cancer, CV diseases, hyperglycemia, and neurological diseases. CONCLUSIONS: Hypoglycaemia can significantly influence the expression of platelet-enriched miRNAs, with a time trend paralleling the time course of platelet activation. This suggests miRNAs could be exploited as biomarkers for platelet activation in response to hypoglycaemia, as they are probably released by platelets upon activation by hypoglycaemic episodes. Should they hold their promise in clinical endpoint studies, platelet-derived miRNAs might become helpful markers of CV risk in subjects with diabetes. Trial registration The study was registered at clinical trials.gov; Impact of Hypoglycaemia in Patients With DIAbetes Mellitus Type 2 on PLATElet Activation (Diaplate), trial number: NCT03460899.


Assuntos
Diabetes Mellitus Tipo 2 , Hipoglicemia , MicroRNAs , Biomarcadores , Plaquetas , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/genética , Humanos , Hipoglicemiantes/uso terapêutico
15.
Vopr Pitan ; 91(2): 5-14, 2022.
Artigo em Russo | MEDLINE | ID: mdl-35596630

RESUMO

The TCF7L2 gene is one of the new markers associated with the development of type 2 diabetes mellitus (DM). Evaluation of the effect of TCF7L2 gene polymorphisms on the effectiveness of hypoglycemic therapy will allow an individual approach to the choice of methods for treating type 2 DM in their carriers. The aim of the research was to study the effect of carriage of TCF7L2 gene polymorphisms on glycemic control parameters in patients with type 2 DM receiving metformin glucose-lowering therapy in combination with a low-calorie version of the standard diet. Material and methods. The study included 55 patients with type 2 DM (mean age 59.9±6.9, BMI 44.3±8.2 kg/m2) receiving metformin monotherapy at a dosage of 1500-2000 mg/day in combination with a low-calorie variant of the standard diet (1730±130 kcal/day). The frequency of occurrence of polymorphisms rs7903146/rs12255372 of the TCF7L2 gene was studied. The indicators of glycemic and metabolic control, anthropometric parameters and body composition were evaluated. Results. The frequency of occurrence of the T-allele of both single nucleotide polymorphisms rs7903146 and rs12255372 of the TCF7L2 gene among patients was 38.2%. Among carriers of the T-allele rs7903146 of the TCF7L2 gene, 72% of patients responded to therapy, showing a statistically significant decrease in the level of fasting glycemia by an average of 16.2±1.6% from the baseline, while among carriers of the CC genotype - 10.5±1.5% (p=0.017). There were no statistically significant changes in glycemic control indicators on hypoglycemic therapy during 7 months of observation, both in the group of T allele and CC genotype carriers. Conclusionss. An improvement in glycemic control was established in patients with type 2 DM among carriers of the T allele rs7903146 of the TCF7L2 gene during metformin therapy in combination with a low-calorie standard diet. The study of TCF7L2 gene polymorphism in combination with indicators of glucose metabolism makes it possible to predict the effectiveness of hypoglycemic therapy with great accuracy.


Assuntos
Diabetes Mellitus Tipo 2 , Metformina , Idoso , Restrição Calórica , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/genética , Predisposição Genética para Doença , Genótipo , Humanos , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Pessoa de Meia-Idade , Polimorfismo de Nucleotídeo Único , Proteína 2 Semelhante ao Fator 7 de Transcrição/genética
16.
Eur Rev Med Pharmacol Sci ; 26(8): 2782-2793, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35503623

RESUMO

OBJECTIVE: To evaluate the efficacy and safety profile of fixed ratio combinations (FRC) in patients with type 2 diabetes mellitus (DMT2) poorly controlled on different insulin regimens. PATIENTS AND METHODS: This multicentric observational study included 376 patients (157 males, 219 female), with longstanding DMT2 inadequately controlled (HbA1c >7%) on different insulin regimens; premix insulin analogs (MIX) (23.2%), basal-bolus regimen (BB) (30.9%) or basal oral therapy (BOT) (37.1%) to whom FRC was introduced at least 6 months prior to data collection. RESULTS: Median age of patients was 67 years, with the duration of diabetes for 14 years, median HbA1c of 8.4% and BMI of 34.35 kg/m2. The proportion of patients treated with IDegLira and IGlarLixi was similar (48.4% vs. 51.6%). There was a borderline difference regarding regimen groups (p = 0.059) implying the greatest improvement of HbA1c in the MIX group. The significant interaction between BOT and BB/MIX regimens (p = 0.011) was noted indicating the largest reduction of BMI in BB and MIX groups. After the FRC administration, there was no significant difference in gastrointestinal (GIT) side-effects. The number of patients with hypoglycemic episodes decreased from 24% to 7% after FRC initiation (p < .001). The group using IGlarLixi required a significantly higher average dose steps compared to IDegLira (p < .001 for all) to achieve glycemic goals, while a larger proportion of patients using IDegLira lost more than 5 kg, compared to IGlarLixi (p < .001). Significant improvement was observed in all glycemic parameters in all insulin treated patients after replacement of insulin therapy with FRC (p < .001 for all). Composite outcome defined as any weight loss and HbA1c below 7% was accomplished in 20.3% of patients. CONCLUSIONS: In real life setting switching to both FRC options in people with longstanding inadequately controlled DMT2 treated with different insulin regimens could offer an effective therapeutic choice for achieving glycemic goals, with an improved safety profile.


Assuntos
Diabetes Mellitus Tipo 2 , Idoso , Glicemia , Diabetes Mellitus Tipo 2/induzido quimicamente , Diabetes Mellitus Tipo 2/tratamento farmacológico , Combinação de Medicamentos , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes , Insulina/uso terapêutico , Insulina Glargina/efeitos adversos , Masculino , Peptídeos
17.
Eur Rev Med Pharmacol Sci ; 26(8): 2802-2817, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35503625

RESUMO

OBJECTIVE: The aim is to assess the comparative efficacy and safety of combination therapy with vildagliptin and metformin vs. metformin monotherapy in the treatment of type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: We searched on PubMed, Cochrane Library, Web of Science, and Embase databases for randomized controlled trials (RCTs) of combination therapy with vildagliptin and metformin vs. metformin monotherapy in patients with T2DM published up to 30 February 2021. The Cochrane tool and Revman 5.3 software was used to assess the risk of bias and conducted the meta-analysis in the included RCTs. Evidence level was assessed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. RESULTS: A total of 11 RCTs and 8533 patients were included. For the efficacy, we found that combination therapy with vildagliptin and metformin (dose of metformin ≥1500mg/d) had a significantly higher reduction in hemoglobin A1c (HbA1c) [mean differences (MD)= -0.59, 95% CI (-0.28, -0.16), p<0.00001] and fasting plasma glucose (FPG) level [MD= -0.82, 95% CI (-1.09, -0.56), p<0.00001] than combination therapy with vildagliptin and metformin (dose of metformin <1500 mg/d). Vildagliptin plus metformin as combination therapy reduced body weight loss ratio [MD=0.22, 95% CI (0.17, 0.27), p<0.00001] when compared with metformin monotherapy. In terms of safety, the vildagliptin plus metformin as combination therapy did not increase risk of total adverse events (AEs) [RR=0.98, 95% CI (0.94,1.02), p=0.29], however there were significant statistical difference and did not increase the risk of diarrhea [RR=0.55, 95% CI (0.40, 0.76), p=0.0003] and Gastrointestinal (GI) disorders [RR=0.72, 95% CI (0.58, 0.91), p=0.006], but significantly increased risk of dizziness [RR=1.41, 95% CI (1.06, 1.88), p=0.02] when compared with metformin monotherapy. CONCLUSIONS: Compared with metformin, vildagliptin combined with metformin could significantly reduce FPG, HbA1c and body weight. When the dose of metformin in the combination group of vildagliptin and metformin is ≥1500mg/d, the results showed significant reduction in HbA1c and FPG. In addition, it had no risk of increase in total AEs, diarrhea, and GI disorders, but had significant risk of increase in dizziness. GRADE showed that the quality of evidence had high certainty in FPG and moderate certainty in HbA1c, body weight and all AEs.


Assuntos
Diabetes Mellitus Tipo 2 , Metformina , Glicemia , Peso Corporal , Diarreia/tratamento farmacológico , Tontura/induzido quimicamente , Quimioterapia Combinada , Hemoglobina A Glicada , Humanos , Hipoglicemiantes/efeitos adversos , Metformina/efeitos adversos , Nitrilas/efeitos adversos , Pirrolidinas/efeitos adversos , Vildagliptina/uso terapêutico
18.
Zhong Nan Da Xue Xue Bao Yi Xue Ban ; 47(4): 462-468, 2022 Apr 28.
Artigo em Inglês, Chinês | MEDLINE | ID: mdl-35545341

RESUMO

OBJECTIVES: Patients with classical type 1 diabetes mellitus (T1DM) require lifelong dependence on exogenous insulin therapy due to pancreatic beta-cell destruction and absolute insulin deficiency. T1DM accounts for about 90% of children with diabetes in China, with a rapid increase in incidence and a younger-age trend. Epidemiological studies have shown that the overall glycated haemoglobin (HbA1c) and compliance rate are low in Chinese children with T1DM. Optimal glucose control is the key for diabetes treatment, and maintaining blood glucose within the target range can prevent or delay chronic vascular complications in patients with T1DM. Therefore, this study aims to investigate the glycemic control of children with T1DM from Hunan and Henan Province with flash glucose monitoring system (FGMS), and to explore factors associated with glycemic variability. METHODS: A total of 215 children with T1DM under 14 years old were enrolled continuously in 16 hospitals from August 2017 to August 2020. All subjects wore a FGMS device to collect glucose data. Correlation of HbA1c, duration of diabetes, or glucose scan rates with glycemic variability was analyzed. Glucose variability was compared according to the duration of diabetes, HbA1c, glucose scan rates and insulin schema. RESULTS: HbA1c and duration of diabetes were positively correlated with mean blood glucose, standard deviation of glucose, mean amplitude of glucose excursions (MAGE), and coefficient of variation (CV) of glucose (all P<0.01). The glucose scan rates during FGMS wearing was significantly positively correlated with time in range (TIR) (P=0.001) and negatively correlated with MAGE and mean duration of hypoglycemia (all P<0.01). Children with duration ≤1 year had lower time below range (TBR) and MAGE when compared with those with duration >1 year (all P<0.05). TIR and TBR in patients with HbA1c ≤7.5% were higher (TIR: 65% vs 45%, TBR: 5% vs 4%, P<0.05), MAGE was lower (7.0 mmol/L vs 9.4 mmol/L, P<0.001) than those in HbA1c >7.5% group. Compared to the multiple daily insulin injections group, TIR was higher (60% vs 52%, P=0.006), MAGE was lower (P=0.006) in the continuous subcutaneous insulin infusion group. HbA1c was lower in the high scan rates (≥14 times/d) group (7.4% vs 8.0%, P=0.046), TIR was significantly higher (58% vs 47%, P<0.001), and MAGE was lower (P<0.001) than those in the low scan rate (<14 times/d) group. CONCLUSIONS: The overall glycemic control of T1DM patients under 14 years old in Hunan and Henan Province is under a high risk of hypoglycemia and great glycemic variability. Shorter duration of diabetes, targeted HbA1c, higher glucose scan rates, and CSII are associated with less glycemic variability.


Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemia , Adolescente , Arritmias Cardíacas , Glicemia , Automonitorização da Glicemia/efeitos adversos , Criança , Diabetes Mellitus Tipo 1/tratamento farmacológico , Glucose , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico
19.
Front Endocrinol (Lausanne) ; 13: 795225, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35528003

RESUMO

In diabetes mellitus (DM) treatment, Continuous Glucose Monitoring (CGM) linked with insulin delivery becomes the main strategy to improve therapeutic outcomes and quality of patients' lives. However, Blood Glucose (BG) regulation with CGM is still hampered by limitations of algorithms and glucose sensors. Regarding sensor technology, current electrochemical glucose sensors do not capture the full spectrum of other physiological signals, i.e., lipids, amino acids or hormones, relaying the general body status. Regarding algorithms, variability between and within patients remains the main challenge for optimal BG regulation in closed-loop therapies. This work highlights the simulation benefits to test new sensing and control paradigms which address the previous shortcomings for Type 1 Diabetes (T1D) closed-loop therapies. The UVA/Padova T1DM Simulator is the core element here, which is a computer model of the human metabolic system based on glucose-insulin dynamics in T1D patients. That simulator is approved by the US Food and Drug Administration (FDA) as an alternative for pre-clinical testing of new devices and closed-loop algorithms. To overcome the limitation of standard glucose sensors, the concept of an islet-based biosensor, which could integrate multiple physiological signals through electrical activity measurement, is assessed here in a closed-loop insulin therapy. This investigation has been addressed by an interdisciplinary consortium, from endocrinology to biology, electrophysiology, bio-electronics and control theory. In parallel to the development of an islet-based closed-loop, it also investigates the benefits of robust control theory against the natural variability within a patient population. Using 4 meal scenarios, numerous simulation campaigns were conducted. The analysis of their results then introduces a discussion on the potential benefits of an Artificial Pancreas (AP) system associating the islet-based biosensor with robust algorithms.


Assuntos
Técnicas Biossensoriais , Diabetes Mellitus Tipo 1 , Glicemia/análise , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Hipoglicemiantes/uso terapêutico , Insulina , Sistemas de Infusão de Insulina , Estados Unidos
20.
Biomed Res Int ; 2022: 8263999, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35528161

RESUMO

Terpenoids and phenols from Trachyspermum ammi (T. ammi) have reported some pharmacological actions. The objective of the work was to isolate the active constituent, its identification by spectroscopic techniques, and evaluation of the antidiabetic and neuroprotective activity from T. ammi on STZ Wistar rats. The dried fruits of T ammi were kept in a hydrodistillation apparatus to collect essential oil. The isolated fraction went through TLC, UV, FTIR, HPLC, HRMS, C13, and 1H NMR for characterization. Two dosage concentrations from the isolated compound were prepared as 10 and 20 mg/kg for treatment groups. The groups were tested for thermal and mechanical hyperalgesia, writhing, grip strength, spontaneous locomotor test, neuromuscular coordination tests, and histopathological and lipid profile analysis. Diabetes was induced by streptozotocin (45 mg/kg i.p.) and 12 weeks of treatment-induced diabetic neuropathy in Wistar rats. Biomarkers were evaluated to understand the neuropathic protection of thymol on STZ-treated Wistar rats. The biomarker studies (SOD, NO, LPO, Na+K+ATPase, and TNF-α) further confirmed thymol's diabetic neuropathy protective action. This study suggests that isolated compound thymol was antidiabetic and neuroprotective as it has shown controlled glucose levels defensive nerve damage in STZ Wistar rats. P < 0.05 level of significance was observed in the levels of endogenous biomarkers, fasting blood glucose levels, actophotometer response, and response latency in treated groups compared to the diabetic group, whereas P < 0.001 level of significance during lipid profile levels, thermal algesia, and neuromuscular comparison tests was noted in treated groups compared to the diabetic group.


Assuntos
Ammi , Apiaceae , Diabetes Mellitus Experimental , Neuropatias Diabéticas , Óleos Voláteis , Animais , Biomarcadores , Glicemia , Diabetes Mellitus Experimental/patologia , Neuropatias Diabéticas/tratamento farmacológico , Frutas , Hipoglicemiantes/farmacologia , Hipoglicemiantes/uso terapêutico , Óleos Voláteis/uso terapêutico , Ratos , Ratos Wistar , Estreptozocina , Timol
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