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Latest & greatest articles for type 2 diabetes
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INDEX (BMI) = 27 KG/M 2 , WHO HAVE FAILED TO ACHIEVE ADEQUATE GLYCAEMIC CONTROL DESPITE OPTIMAL INSULIN THERAPY Project ID: PTJA04 PTJA04 - Sotagliflozin is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) = 27 kg/m 2 , who have failed to achieve adequate glycaemic control despite optimal insulin therapy June 2019 EUnetHTA Joint Action 3 WP4 2 DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V1.0 16 (...) authors, co-authors dedicated reviewers and external clinical expert involved in the production of this assessment have declared that they have no conflicts of interest in relation to the technology assessed according to the EUnetHTA Declaration of Interest and Confidentiality Undertaking form. PTJA04 - Sotagliflozin is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) = 27 kg/m 2 , who have failed to achieve
and why it is authorised in the EU What is Zynquista and what is it used for? Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes. It is used in overweight patients (body mass index of at least 27 kg/m 2 ) when insulin on its own does not control blood sugar well enough. Zynquista contains the active substance sotagliflozin. How is Zynquista used? Zynquista is available as 200 mg tablets. The recommended dose is 1 tablet once a day before the first meal of the day (...) . After 3 months, the doctor may increase the dose to 2 tablets once a day if additional blood sugar control is needed. The medicine should be used with precautions to reduce the risk of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood). Zynquista can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in managing type 1 diabetes. For more information about using Zynquista, see the package leaflet
REPORTING ON LIFE EXPECTANCY 15 3.2.1. Literature search 15 3.2.2. The Scottish registry-based cohort study by Livingstone et al. 15 3.2.3. The Swedish registry-based cohort study by Petrie et al 16 2 Excess mortality and life expectancy of individuals with type 1 diabetes KCE Report 314 3.2.4. The Australian registry-based cohort study by Huo et al.. 16 3.2.5. Consistency of the evidence in the Scottish, Swedish and Australian cohort studies 17 3.2.6. The Taiwanese longitudinal cohort study based (...) 6 Excess mortality and life expectancy of individuals with type 1 diabetes KCE Report 314 PAD Peripheral Artery Disease PICO(D) Patient, Intervention, Comparator, Outcome, (Design) PY, PYE Patient Years (of Exposure or follow-up): PY or PYE can be used interchangeably RF Risk Factor(s) RR Relative Risk SMR Standardized Mortality Ratio SR Systematic Review T1D Type 1 Diabetes T2D Type2Diabetes y Year YLL Years of Life Lost KCE Report 314 Excess mortality and life expectancy of individuals
Durability of a primary care-led weight-management intervention for remission of type2diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial The DiRECT trial assessed remission of type2diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect.DiRECT (...) assistants were aware of allocation. We recruited individuals aged 20-65 years, with less than 6 years' duration of type2diabetes, BMI 27-45 kg/m2, and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825-853 kcal per day formula diet for 12-20 weeks), stepped food reintroduction (2-8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed
Liraglutide in Children and Adolescents with Type2Diabetes. Metformin is the regulatory-approved treatment of choice for most youth with type2diabetes early in the disease. However, early loss of glycemic control has been observed with metformin monotherapy. Whether liraglutide added to metformin (with or without basal insulin treatment) is safe and effective in youth with type2diabetes is unknown.Patients who were 10 to less than 17 years of age were randomly assigned, in a 1:1 ratio (...) %] with liraglutide and 55 [80.9%] with placebo), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.In children and adolescents with type2diabetes, liraglutide, at a dose of up to 1.8 mg per day (added to metformin, with or without basal insulin), was efficacious in improving glycemic control over 52 weeks. This efficacy came at the cost of an increased frequency of gastrointestinal adverse events. (Funded by Novo Nordisk; Ellipse ClinicalTrials.gov number
Maternal Glycemic Control in Type 1 Diabetes and the Risk for Preterm Birth: A Population-Based Cohort Study. Maternal type 1 diabetes (T1D) has been linked to preterm birth and other adverse pregnancy outcomes. How these risks vary with glycated hemoglobin (or hemoglobin A1c [HbA1c]) levels is unclear.To examine preterm birth risk according to periconceptional HbA1c levels in women with T1D.Population-based cohort study.Sweden, 2003 to 2014.2474 singletons born to women with T1D and 1 165 216 (...) reference infants born to women without diabetes.Risk for preterm birth (<37 gestational weeks). Secondary outcomes were neonatal death, large for gestational age, macrosomia, infant birth injury, hypoglycemia, respiratory distress, 5-minute Apgar score less than 7, and stillbirth.Preterm birth occurred in 552 (22.3%) of 2474 infants born to mothers with T1D versus 54 287 (4.7%) in 1 165 216 infants born to mothers without diabetes. The incidence of preterm birth was 13.2% in women
Metformin and second- or third-generation sulphonylurea combination therapy for adults with type2diabetes mellitus. The number of people with type2diabetes mellitus (T2DM) is increasing worldwide. The combination of metformin and sulphonylurea (M+S) is a widely used treatment. Whether M+S shows better or worse effects in comparison with other antidiabetic medications for people with T2DM is still controversial.To assess the effects of metformin and sulphonylurea (second- or third-generation (...) ) combination therapy for adults with type2diabetes mellitus.We updated the search of a recent systematic review from the Agency for Healthcare Research and Quality (AHRQ). The updated search included CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP. The date of the last search was March 2018. We searched manufacturers' websites and reference lists of included trials, systematic reviews, meta-analyses and health technology assessment reports. We asked investigators of the included trials
Canagliflozin and Renal Outcomes in Type2Diabetes and Nephropathy. Type2diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type2 diabetes.In this double-blind, randomized trial, we assigned patients with type2diabetes and albuminuric chronic (...) had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P = 0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture.In patients with type2diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years
Atrasentan and renal events in patients with type2diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial. Short-term treatment for people with type2diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes.We did this double-blind, randomised, placebo-controlled trial (...) at 689 sites in 41 countries. We enrolled adults aged 18-85 years with type2diabetes, estimated glomerular filtration rate (eGFR) 25-75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g who had received maximum labelled or tolerated renin-angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30
Incidence of type2diabetes mellitus in men receiving steroid 5α-reductase inhibitors: population based cohort study. To investigate the incidence of new onset type2diabetes mellitus in men receiving steroid 5α-reductase inhibitors (dutasteride or finasteride) for long term treatment of benign prostatic hyperplasia.Population based cohort study.UK Clinical Practice Research Datalink (CPRD; 2003-14) and Taiwanese National Health Insurance Research Database (NHIRD; 2002-12).Men in the CPRD who (...) received dutasteride (n=8231), finasteride (n=30 774), or tamsulosin (n=16 270) were evaluated. Propensity score matching (2:1; dutasteride to finasteride or tamsulosin) produced cohorts of 2090, 3445, and 4018, respectively. In the NHIRD, initial numbers were 1251 (dutasteride), 4194 (finasteride), and 86 263 (tamsulosin), reducing to 1251, 2445, and 2502, respectively, after propensity score matching.Incident type2diabetes using a Cox proportional hazard model.In the CPRD, 2081 new onset type2
Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials. To assess the efficacy and safety of dual sodium glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin in type 1 diabetes mellitus.Meta-analysis of randomised controlled trials.Medline; Cochrane Library; Embase; international meeting abstracts; international and national clinical trial registries; and websites of US, European, and Japanese regulatory authorities, up (...) to 10 January 2019.Randomised controlled trials evaluating the effect of sotagliflozin versus active comparators or placebo on glycaemic and non-glycaemic outcomes and on adverse events in type 1 diabetes in participants older than 18. Three reviewers extracted data for study characteristics, outcomes of interest, and risk of bias and summarised strength of evidence using the grading of recommendations assessment, development, and evaluation approach. Main outcomes were pooled using random effects
Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation. To compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes in children and young people.Pragmatic, multicentre, open label, parallel group (...) , randomised controlled trial and economic evaluation.15 paediatric National Health Service (NHS) diabetes services in England and Wales. The study opened to recruitment in May 2011 and closed in January 2017.Patients aged between 7 months and 15 years, with a new diagnosis of type 1 diabetes were eligible to participate. Patients who had a sibling with the disease, and those who took drug treatments or had additional diagnoses that could have affected glycaemic control were ineligible.Participants were
Dapagliflozin/metformin (type2diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports A17-66 Dapagliflozin/metformin (type2diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-66 Version 1.0 Dapagliflozin/metformin (type2diabetes mellitus) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin/metformin (type2diabetes mellitus) – Benefit
Dapagliflozin (type2diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Dapagliflozin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG (...) Reports – Commission No. A17-65 Dapagliflozin (type2diabetes mellitus) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-65 Version 1.0 Dapagliflozin (type2diabetes mellitus) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dapagliflozin (type2diabetes mellitus) – Benefit assessment according to §35a Social
AACE/ACE Comprehensive Type2Diabetes Management Algorithm CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE2DIABETES MANAGEMENT ALGORITHM – 2019 EXECUTIVE SUMMARY | Endocrine Practice | | > > > CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOL... Volume 25, Issue 1 (January 2019) Alerts for the Journal Click to get an email alert for every new issue of Endocrine Practice X Email (...) , Janet B. McGill , Jeffrey I. Mechanick , Paul D. Rosenblit , and Guillermo E. Umpierrez ( 2019 ) CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE2DIABETES MANAGEMENT ALGORITHM – 2019 EXECUTIVE SUMMARY . Endocrine Practice: January 2019, Vol. 25, No. 1, pp. 69-100. AACE/ACE Consensus Statement CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY
Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type2Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. Phase 3 trials have not compared oral semaglutide, a glucagon-like peptide 1 receptor agonist, with other classes of glucose-lowering therapy.To compare efficacy and assess long-term adverse event profiles of once-daily oral semaglutide vs sitagliptin, 100 mg added on to metformin (...) with or without sulfonylurea, in patients with type2 diabetes.Randomized, double-blind, double-dummy, parallel-group, phase 3a trial conducted at 206 sites in 14 countries over 78 weeks from February 2016 to March 2018. Of 2463 patients screened, 1864 adults with type2diabetes uncontrolled with metformin with or without sulfonylurea were randomized.Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467
Effect of a Behavioral Intervention Strategy on Sustained Change in Physical Activity and Sedentary Behavior in Patients With Type2Diabetes: The IDES_2 Randomized Clinical Trial. There is no definitive evidence that changes in physical activity/sedentary behavior can be maintained long term in individuals with type2 diabetes.To investigate whether a behavioral intervention strategy can produce a sustained increase in physical activity and reduction in sedentary time among individuals (...) with type2 diabetes.The Italian Diabetes and Exercise Study 2 was an open-label, assessor-blinded, randomized clinical superiority trial, with recruitment from October 2012 to February 2014 and follow-up until February 2017. In 3 outpatient diabetes clinics in Rome, 300 physically inactive and sedentary patients with type2diabetes were randomized 1:1 (stratified by center, age, and diabetes treatment) to receive a behavioral intervention or standard care for 3 years.All participants received usual
Automated insulin dosing guidance to optimise insulin management in patients with type2diabetes: a multicentre, randomised controlled trial. Insulin therapy is most effective if dosage titrations are done regularly and frequently, which is seldom practical for most clinicians, resulting in an insulin titration gap. The d-Nav Insulin Guidance System (Hygieia, Livonia, MI, USA) is a handheld device that is used to measure glucose, determine glucose patterns, and automatically determine (...) the appropriate next insulin dose. We aimed to determine whether the combination of the d-Nav device and health-care professional support is superior to health-care professional support alone.In this multicentre, randomised, controlled study, we recruited patients from three diabetes centres in the USA (in Detroit MI; Minneapolis, MN; and Des Moines IA). Patients were eligible if they were aged 21-70 years, diagnosed with type2diabetes with a glycated haemoglobin (HbA1c) concentration of 7·5% or higher (≥58