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Latest & greatest articles for type 2 diabetes
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Empaglifozin linagliptin fixed-dose combination (Glyxambi) - type2diabetes mellitus: Published 12 August 2019 1 Product Update: empagliflozin plus linagliptin 10mg/5mg, 25mg/5mg film-coated tablets (Glyxambi ® ) SMC No. (1236/17) Boehringer Ingelheim Ltd. 07 April 2017 (Issued July 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice (...) is summarised as follows: ADVICE: following an abbreviated submission empagliflozin/linagliptin (Glyxambi ® ) is accepted for restricted use within NHS Scotland. Indication under review: in adults aged 18 years and older with type2diabetes mellitus: ? To improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi ® do not provide adequate glycaemic control ? When already being treated with the free combination of empagliflozin and linagliptin SMC
Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type2diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type2diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg.In this 52-week, multicentre, randomised, open-label (...) , phase 3a trial, we recruited patients with type2diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type2diabetes (diagnosed ≥90 days before screening), HbA1c of 7·5-9·5% (58-80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system
Effects of dapagliflozin on development and progression of kidney disease in patients with type2diabetes: an analysis from the DECLARE-TIMI 58 randomised trial Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE-TIMI 58 cardiovascular outcomes trial, which included patients (...) with type2diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.In DECLARE-TIMI 58, patients with type2diabetes, HbA1c 6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min were randomly assigned (1:1) to 10 mg dapagliflozin or placebo once daily. A prespecified secondary cardiorenal composite outcome was defined
Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard (...) ) in hypoglycaemia-prone adults with type 1 diabetes.SMILE was an open-label randomised controlled trial done in people aged 24-75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8-10·0% (40-86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After
Oral Semaglutide and Cardiovascular Outcomes in Patients with Type2Diabetes. Establishing cardiovascular safety of new therapies for type2diabetes is important. Safety data are available for the subcutaneous form of the glucagon-like peptide-1 receptor agonist semaglutide but are needed for oral semaglutide.We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (...) of 1592 (1.0%), respectively (hazard ratio, 0.74; 95% CI, 0.35 to 1.57). Death from any cause occurred in 23 of 1591 patients (1.4%) in the oral semaglutide group and 45 of 1592 (2.8%) in the placebo group (hazard ratio, 0.51; 95% CI, 0.31 to 0.84). Gastrointestinal adverse events leading to discontinuation of oral semaglutide or placebo were more common with oral semaglutide.In this trial involving patients with type2diabetes, the cardiovascular risk profile of oral semaglutide was not inferior
An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. Type 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed.We conducted a phase 2, randomized, placebo-controlled, double-blind trial (...) of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo, and follow-up for progression to clinical type 1 diabetes was performed with the use of oral glucose-tolerance tests at 6-month intervals.A total of 76 participants (55 [72%] of whom were ≤18 years of age) underwent
Dulaglutide and renal outcomes in type2diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type2diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease.REWIND was a multicentre (...) , randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type2diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum
Dulaglutide and cardiovascular outcomes in type2diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type2diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens (...) of individuals with type2diabetes with and without previous cardiovascular disease and a wide range of glycaemic control.This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type2diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer
Vitamin D Supplementation and Prevention of Type2Diabetes. Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type2diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown.We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per (...) was 0.88 (0.95% confidence interval, 0.75 to 1.04; P = 0.12). The incidence of adverse events did not differ significantly between the two groups.Among persons at high risk for type2diabetes not selected for vitamin D insufficiency, vitamin D3 supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694
Oral semaglutide versus subcutaneous liraglutide and placebo in type2diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Glucagon-like peptide-1 (GLP-1) receptor agonists are effective treatments for type2diabetes, lowering glycated haemoglobin (HbA1c) and weight, but are currently only approved for use as subcutaneous injections. Oral semaglutide, a novel GLP-1 agonist, was compared with subcutaneous liraglutide and placebo in patients with type2 diabetes.In this randomised (...) , double-blind, double-dummy, phase 3a trial, we recruited patients with type2diabetes from 100 sites in 12 countries. Eligible patients were aged 18 years or older, with HbA1c of 7·0-9·5% (53-80·3 mmol/mol), on a stable dose of metformin (≥1500 mg or maximum tolerated) with or without a sodium-glucose co-transporter-2 inhibitor. Participants were randomly assigned (2:2:1) with an interactive web-response system and stratified by background glucose-lowering medication and country of origin, to once
Intensive Glucose Control in Patients with Type2Diabetes - 15-Year Follow-up. We previously reported that a median of 5.6 years of intensive as compared with standard glucose lowering in 1791 military veterans with type2diabetes resulted in a risk of major cardiovascular events that was significantly lower (by 17%) after a total of 10 years of combined intervention and observational follow-up. We now report the full 15-year follow-up.We observationally followed enrolled participants (...) of separation of the glycated hemoglobin curves (hazard ratio, 0.83; 95% CI, 0.70 to 0.99), but this benefit did not continue after equalization of the glycated hemoglobin levels (hazard ratio, 1.26; 95% CI, 0.90 to 1.75).Participants with type2diabetes who had been randomly assigned to intensive glucose control for 5.6 years had a lower risk of cardiovascular events than those who received standard therapy only during the prolonged period in which the glycated hemoglobin curves were separated
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
Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type2diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, plac In patients with type2diabetes, intensive glucose control can be renoprotective and albuminuria-lowering treatments can slow the deterioration of kidney function. We assessed the albuminuria-lowering effect of the sodium-glucose co (...) -transporter-2 inhibitor dapagliflozin with and without the dipeptidyl peptidase-4 inhibitor saxagliptin, and the effect of dapagliflozin-saxagliptin on glycaemic control in patients with type2diabetes and moderate-to-severe chronic kidney disease.In this double-blind, placebo-controlled trial (DELIGHT), we enrolled patients at 116 research centres in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain, Taiwan, and the USA. We included patients with a known history of type2diabetes
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
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
Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type2diabetes (SUSTAIN 9): a randomised, placebo-controlled trial Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analogue for type2diabetes. Few clinical trials have reported on the concomitant use of GLP-1 receptor agonists with sodium-glucose cotransporter-2 (SGLT-2) inhibitors. We aimed to investigate the efficacy and safety of semaglutide when added to SGLT-2 inhibitor therapy in patients with inadequately (...) controlled type2 diabetes.The SUSTAIN 9 double-blind, parallel-group trial was done at 61 centres in six countries (Austria, Canada, Japan, Norway, Russia, and the USA). Adults with type2diabetes and HbA1c 7·0-10·0% (53-86 mmol/mol), despite at least 90 days of treatment with an SGLT-2 inhibitor, were randomly assigned (1:1) to receive subcutaneous semaglutide 1·0 mg or volume-matched placebo once weekly for 30 weeks, after a dose-escalation schedule of 4 weeks of 0·25 mg semaglutide or placebo and 4
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