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Latest & greatest articles for insulin
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Glycaemic Efficacy and Safety of Linagliptin compared to Basal-Bolus Insulin Regimen in Patients with Type 2 Diabetes Undergoing Non-Cardiac Surgery: A Multicenter Randomized Clinical Trial The use of incretin-based therapy instead of or complementary to insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined glycaemic efficacy and safety of linagliptin compared to basal-bolus insulin regimen in hospitalized surgical patients (...) with T2D.This prospective open-label multicenter study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose(BG) 7.8-22.2 mmol/L treated with diet, oral agents or total insulin dose(TDD) ≤0.5 units/kg/day to linagliptin(n=128) daily or basal-bolus(n=122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG>7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups.Mean daily BG was inferior
Insulin glargine/lixisenatide fixed-ratio combination improves glycaemic variability and control without increasing hypoglycaemia Maintaining optimal glycaemic control reduces the risk of micro- and macrovascular complications in patients with type 2 diabetes. Typically, glycaemic control is based on glycated haemoglobin (HbA1c) as a measure of mean glucose concentration; however, this marker does not accurately reflect glycaemic variability (GV), which is characterized by the amplitude (...) , frequency and duration of hypo- and hyperglycaemic fluctuations. In the present study, we analysed data from the LixiLan-O trial, which compared iGlarLixi, a titratable fixed-ratio combination of the glucagon-like peptide-1 receptor agonist lixisenatide (Lixi) and long-acting basal insulin glargine 100 units/mL (iGlar), with its individual components, and the LixiLan-L trial, which compared iGlarLixi with iGlar. The GV features that were measured were mean and SD of self-measured plasma glucose (SMPG
DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at h Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day (...) and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes.This was a prospective, multicentre, crossover, controlled study (clinicaltrials.gov NCT01238406). All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System. In the intervention arm only, the amount of carbohydrate was entered into the bolus calculator; the rest of insulin delivery was automated and wireless via
Pilot Study on the Effect of Orally Administered Bisphenol A on Glucose and Insulin Response in Nonobese Adults. To determine the effects of varying doses of orally administered BPA on indices of glucose metabolism.Eleven college students (21.0 ± 0.8 years; 24.2 ± 3.9 kg/m2) were randomized in a double-blinded, crossover fashion separated by >1 week to placebo (PL), deuterated BPA at 4 µg/kg body weight (BPA-4), and deuterated BPA at 50 µg/kg body weight (BPA-50). Total BPA, glucose, insulin (...) , and C-peptide were assessed at baseline, minutes 15, 30, 45, 60, and every 30 minutes for 2 hours in response to a glucose tolerance test.There was a significant condition × time interaction for total BPA (P < 0.001) such that BPA increased more rapidly in BPA-50 than BPA-4 and PL (P = 0.003) and increased more rapidly in BPA-4 than PL (P < 0.001). There were no significant condition × time interactions on glucose, insulin, and C-peptide. Significant condition main effects were observed for glucose
Efficacy and safety of once-weekly dulaglutide versus insulin glargine in mainly Asian patients with type 2 diabetes mellitus on metformin and/or a sulphonylurea: A 52-week open-label, randomized phase III trial To compare the efficacy and safety of once-weekly dulaglutide with that of insulin glargine in combination with metformin and/or a sulphonylurea in mainly Asian patients with type 2 diabetes mellitus (T2DM).In this 52-week, randomized, parallel-arm open-label study, we enrolled patients (...) %) than in the glargine group at week 26 (P < 0.001 and P = 0.004, respectively). Body weight decreased with dulaglutide and increased with glargine. The incidence and rate of total hypoglycaemia were lower with dulaglutide versus glargine. Gastrointestinal adverse events, including diarrhoea and nausea, were the most frequently reported for patients taking dulaglutide.Once-weekly dulaglutide provides greater improvement in HbA1c, with weight loss and less hypoglycaemia, than once-daily insulin
Efficacy of an Education Program for People With Diabetes and Insulin Pump Treatment (INPUT): Results From a Randomized Controlled Trial Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin delivery, but it requires structured education to provide users with the necessary knowledge/skills and to support their motivation. Currently, no structured education program designed to provide this training has been evaluated. We developed a CSII-specific, structured (...) education program (Insulin Pump Treatment [INPUT]) and evaluated its impact on glycemic control, behavior, and psychosocial status.This was a multicenter, randomized, parallel trial with a 6-month follow-up. Eligible participants (age 16-75 years) currently were treated with insulin pump therapy. Participants were randomly assigned (1:1) to the INPUT program or to usual care using a computer-generated algorithm, with study center as the stratification factor. The primary outcome was HbA1c change from
Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials To evaluate the safety and efficacy of empagliflozin 10- and 25-mg doses plus a unique lower dose (2.5 mg) as adjunct to intensified insulin in patients with type 1 diabetes (T1D).The EASE (Empagliflozin as Adjunctive to inSulin thErapy) program (N = 1,707) included two double-blind, placebo-controlled phase 3 trials: EASE-2 with empagliflozin 10 mg (n = 243), 25 mg (n = 244), and placebo (n = 243), 52-week (...) treatment; and EASE-3 with empagliflozin 2.5 mg (n = 241), 10 mg (n = 248), 25 mg (n = 245), and placebo (n = 241), 26-week treatment. Together they evaluated empagliflozin 10 mg and 25 mg, doses currently approved in treatment of type 2 diabetes, and additionally 2.5 mg on 26-week change in glycated hemoglobin (primary end point) and weight, glucose time-in-range (>70 to ≤180 mg/dL), insulin dose, blood pressure, and hypoglycemia.The observed largest mean placebo-subtracted glycated hemoglobin
Do current guidelines for waist circumference apply to black Africans? Prediction of insulin resistance by waist circumference among Africans living in America To lower the risk of diabetes and heart disease in Africa, identification of African-centred thresholds for inexpensive biomarkers of insulin resistance (IR) is essential. The waist circumference (WC) thresholds that predicts IR in African men and women have not been established, but investigations recently conducted in Africa using
Advances in Glucose Monitoring and Automated Insulin Delivery: Supplement to Endocrine Society Clinical Practice Guidelines Endocrine Society guideline recommendations on diabetes technology in adults originate from the 2016 guideline titled "Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline." Society recommendations on diabetes technology in children are contained in the 2011
Heart Failure After Ischemic Stroke or TIA in Insulin-Resistant Patients Without Diabetes Treated with Pioglitazone The IRIS trial (Insulin Resistance Intervention After Stroke) demonstrated that pioglitazone reduced the risk for both cardiovascular events and diabetes mellitus in insulin-resistant patients. However, concern remains that pioglitazone may increase the risk for heart failure (HF) in susceptible individuals.In IRIS, patients with insulin resistance but without diabetes mellitus (...) adjustments, pioglitazone did not increase the risk of HF and conferred net cardiovascular benefit in patients with insulin resistance and cerebrovascular disease. The risk of HF with pioglitazone was not modified by baseline HF risk. The IRIS experience may be instructive for maximizing the net benefit of this therapy.URL: https://www.clinicaltrials.gov . Unique identifier: NCT00091949.
XULTOPHY (insulin degludec/liraglutide), antidiabetic Haute Autorité de Santé - XULTOPHY (insuline degludec/liraglutide), antidiabétique Développer la qualité dans le champ sanitaire, social et médico-social Recherche Évaluation & Recommandation La HAS Accréditation & Certification Outils, Guides & Méthodes Agenda Avis sur les Médicaments XULTOPHY (insuline degludec/liraglutide), antidiabétique Substance active (DCI) insuline degludec liraglutide DIABETOLOGIE - Mise au point Nature de la (...) demande Modification des conditions d'inscription Avis de la CT du 06 décembre 2017 Intérêt clinique important chez les diabétiques de type 2 mais pas d’avantage clinique démontré en cas d’échec du contrôle glycémique de l’association metformine / insuline basale XULTOPHY a l’AMM dans le traitement du diabète de type 2 de l’adulte pour améliorer le contrôle glycémique en association aux antidiabétiques oraux lorsque ceux-ci, seuls ou associés à une insuline basale, ne permettent pas d’obtenir un
Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. The achievement of glycaemic control remains challenging for patients with type 1 diabetes. We assessed the effectiveness of day-and-night hybrid closed-loop insulin delivery compared with sensor-augmented pump therapy in people with suboptimally controlled type 1 diabetes aged 6 years and older.In this open-label, multicentre, multinational, single-period, parallel randomised (...) controlled trial, participants were recruited from diabetes outpatient clinics at four hospitals in the UK and two centres in the USA. We randomly assigned participants with type 1 diabetes aged 6 years and older treated with insulin pump and with suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7·5-10·0%) to receive either hybrid closed-loop therapy or sensor-augmented pump therapy over 12 weeks of free living. Training on study insulin pump and continuous glucose monitoring took place over
2018LancetControlled trial quality: predicted high
Production costs and potential prices for biosimilars of human insulin and insulin analogues High prices for insulin pose a barrier to treatment for people living with diabetes, with an estimated 50% of 100 million patients needing insulin lacking reliable access. As insulin analogues replace regular human insulin (RHI) globally, their relative prices will become increasingly important. Three originator companies control 96% of the global insulin market, and few biosimilar insulins (...) are available. We estimated the price reductions that could be achieved if numerous biosimilar manufacturers entered the insulin market.Data on the price of active pharmaceutical ingredient (API) exported from India were retrieved from an online customs database. Manufacturers of insulins were contacted for price quotes. Where market API prices could not be identified, prices were estimated based on comparison of similarity, in terms of manufacturing process, with APIs for which prices were available
U500 Disposable Patch Insulin Pump: Results and Discussion of a Veterans Affairs Pilot Study We present a Veterans Affairs-sponsored pilot study of U500 concentrated insulin administered via disposable patch insulin pump (DPIP) vs twice-daily (BID) injections with an insulin pen in a case series format. We conducted a prospective, single-center, randomized, intent-to-treat pilot study. Ten participants were enrolled with poorly controlled diabetes, defined as hemoglobin A1C >8.0 and severe (...) insulin resistance defined as total daily dose >200 units. Participants were randomized in a 1:1 ratio to either U500 DPIP or U500 BID insulin titration protocols for 14 weeks. A clinical pattern emerged where four participants randomized to the DPIP treatment arm were withdrawn early as the DPIP did not work well for the purpose studied. There was not a statistically significant difference in the rate of hypoglycemia between treatment arms. Based on our clinical experience and results, we argue
Experimental BPA Exposure and Glucose-Stimulated Insulin Response in Adult Men and Women Human cross-sectional and animal studies have shown an association of the chemical bisphenol A (BPA) with insulin resistance, type 2 diabetes, and other metabolic diseases, but no human experimental study has investigated whether BPA alters insulin/C-peptide secretion.Men and postmenopausal women (without diabetes) were orally administered either the vehicle or a BPA dose of 50 µg/kg body weight, which has (...) been predicted by US regulators (Food and Drug Administration, Environmental Protection Agency) to be the maximum, safe daily oral BPA dose over the lifetime. Insulin response was assessed in two cross-over experiments using an oral glucose tolerance test (OGTT; experiment 1) and a hyperglycemic (HG) clamp (experiment 2). Main outcomes were the percentage change of BPA session measures relative to those of the control session.Serum bioactive BPA after experimental exposure was at levels detected
Dicarbonyl Stress and Glyoxalase-1 in Skeletal Muscle: Implications for Insulin Resistance and Type 2 Diabetes Glyoxalase-1 (GLO1) is a ubiquitously expressed cytosolic protein which plays a role in the natural maintenance of cellular health and is abundantly expressed in human skeletal muscle. A consequence of reduced GLO1 protein expression is cellular dicarbonyl stress, which is elevated in obesity, insulin resistance and type 2 diabetes (T2DM). Both in vitro and pre-clinical models suggest (...) dicarbonyl stress per se induces insulin resistance and is prevented by GLO1 overexpression, implicating a potential role for GLO1 therapy in insulin resistance and type 2 diabetes (T2DM). Recent work has identified the therapeutic potential of novel natural agents as a GLO1 inducer, which resulted in improved whole-body metabolism in obese adults. Given skeletal muscle is a major contributor to whole-body glucose, lipid, and protein metabolism, such GLO1 inducers may act, in part, through mechanisms
Medicines for Treatment Intensification in Type 2 Diabetes and Type of Insulin in Type 1 and Type 2 Diabetes in Low-Resource Settings: Synopsis of the World Health Organization Guidelines on Second- and Third-Line Medicines and Type of Insulin for the Con The World Health Organization developed these guidelines to provide guidance on selection of medicines for treatment intensification in type 2 diabetes and on use of insulin (human or analogue) in type 1 and 2 diabetes. The target audience (...) 2007 to 1 March 2017. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to assess the quality of the evidence and the strength of the recommendations. The guideline was peer-reviewed by 6 external reviewers.Give a sulfonylurea to patients with type 2 diabetes who do not achieve glycemic control with metformin alone or who have contraindications to metformin (strong recommendation, moderate-quality evidence).Introduce human insulin treatment to patients
Efficacy of iGlarLixi, a fixed-ratio combination of insulin glargine and lixisenatide, in patients with type 2 diabetes stratified as at high or low risk according to HEDIS measurements The Healthcare Effectiveness Data and Information Set (HEDIS) measurements assess glycaemic goal attainment in patients with type 2 diabetes, incorporating factors including age and health status. Healthier patients are assigned a glycated haemoglobin (HbA1c) goal of <7% (low-risk [LR]) and individuals aged >65 (...) years or with comorbidities are assigned a goal of <8% (high-risk [HR]). This post-hoc analysis assessed the safety and efficacy of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and lixisenatide, in 1898 patients from the phase 3 LixiLan-L and LixiLan-O clinical trials, retrospectively classified as LR (n = 1181) or HR (n = 717). iGlarLixi was more effective in reducing HbA1c than comparators in both LR and HR patients across the LixiLan-L trial (change from baseline, 1.1
More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial To compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial.BRIGHT (NCT02738151) was a multicenter, open-label, active-controlled, two-arm, parallel-group, 24-week, noninferiority study in insulin-naive patients (...) mean difference -0.05% (95% CI -0.15 to 0.05) (-0.6 mmol/mol [-1.7 to 0.6])-demonstrating noninferiority of Gla-300 versus IDeg-100 (P < 0.0001). Hypoglycemia incidence and event rates over 24 weeks were comparable with both insulins, whereas during the active titration period (0-12 weeks) the incidence and rate of anytime (24-h) confirmed hypoglycemia (≤70 and <54 mg/dL) were lower with Gla-300. Both insulins were properly titrated and exhibited no specific safety concerns.Gla-300 and IDeg-100