Latest & greatest articles for type 1 diabetes

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Top results for type 1 diabetes

121. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. (Abstract)

Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Glucagon-like peptide-1 (GLP-1) receptor agonists are effective treatments for type 2 diabetes, 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 type 2 diabetes.In this randomised (...) , double-blind, double-dummy, phase 3a trial, we recruited patients with type 2 diabetes 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

2019 Lancet Controlled trial quality: predicted high

122. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. (Abstract)

Dulaglutide and renal outcomes in type 2 diabetes: 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 type 2 diabetes 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 type 2 diabetes 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

2019 Lancet Controlled trial quality: predicted high

123. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. (Abstract)

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes 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 type 2 diabetes 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 type 2 diabetes 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

2019 Lancet Controlled trial quality: predicted high

124. Vitamin D Supplementation and Prevention of Type 2 Diabetes. Full Text available with Trip Pro

Vitamin D Supplementation and Prevention of Type 2 Diabetes. Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. 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 type 2 diabetes 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

2019 NEJM Controlled trial quality: predicted high

125. Intensive Glucose Control in Patients with Type 2 Diabetes - 15-Year Follow-up. Full Text available with Trip Pro

Intensive Glucose Control in Patients with Type 2 Diabetes - 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 type 2 diabetes 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 type 2 diabetes 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

2019 NEJM

126. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial (Abstract)

Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes.After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years (...) insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp.In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA1c control compared with IAsp.© 2019 by the American Diabetes Association.

2019 EvidenceUpdates

127. Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: A multicentre, randomized controlled trial using continuous glucose monitoring Full Text available with Trip Pro

Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: A multicentre, randomized controlled trial using continuous glucose monitoring Video abstract: View a video abstract for this article.This multicentre (N = 104), randomized controlled phase 4 study compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with insulin glargine 100 units/mL (Gla-100) in patients with type 1 (...) diabetes (T1D).Patients were randomized 1:1 to self-perform morning Gla-300 or Gla-100 injections daily for 16 weeks. The primary endpoint was percentage of time blood glucose remained in the target range (70-180 mg/dL) during Week 15/16, measured by blinded continuous glucose monitoring. Secondary endpoints included incidence and rate of nocturnal symptomatic hypoglycaemia (≤70 mg/dL), glycaemic variability parameters and safety assessments. Exploratory analyses were performed in patients

2019 EvidenceUpdates

128. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction Full Text available with Trip Pro

Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction Sodium glucose transporter-2 inhibitors reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus and a history of atherosclerotic cardiovascular disease. Because of their baseline risk, patients with previous myocardial infarction (MI) may derive even greater benefit from sodium glucose transporter-2 inhibitor therapy.DECLARE-TIMI (...) 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58) randomized 17 160 patients with type 2 diabetes mellitus and either established atherosclerotic cardiovascular disease (n=6974) or multiple risk factors (n=10 186) to dapagliflozin versus placebo. The 2 primary end points were composite of MACE (cardiovascular death, MI, or ischemic stroke) and the composite of cardiovascular death or hospitalization for heart failure. Those with previous MI (n=3584) made

2019 EvidenceUpdates

129. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus Full Text available with Trip Pro

Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus In DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the composite end point of cardiovascular death/hospitalization for heart failure (HHF) in a broad population of patients with type 2 diabetes mellitus. However, the impact of baseline left ventricular ejection fraction (EF) on the clinical (...) with type 2 diabetes mellitus stratified by EF, we found that dapagliflozin reduced HHF in patients with and without HFrEF and reduced cardiovascular death and all-cause mortality in patients with HFrEF.URL: https://www.clinicaltrials.gov . Unique identifier: NCT01730534.

2019 EvidenceUpdates

130. Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD (Abstract)

Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD Hyperglycemia exacerbates the progression of chronic kidney disease (CKD), but most glucose-lowering therapies do not address morbidities associated with CKD. Sodium/glucose cotransporter 2 (SGLT2) inhibitors offer potential benefits to patients with diabetes and CKD, but their effectiveness may be diminished with decreased kidney function. We aimed to evaluate the safety and effectiveness (...) of bexagliflozin, a novel SGLT2 inhibitor, in patients with type 2 diabetes and CKD.Phase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial.54 sites across 4 countries. Patients with CKD stage 3a or 3b, type 2 diabetes mellitus, and hemoglobin A1c level of 7.0% to 10.5% and estimated glomerular filtration rate (eGFR) of 30 to 59mL/min/1.73m2 who were taking oral hypoglycemic agents for 8 weeks.Bexagliflozin, 20mg, daily versus placebo for 24 weeks.Primary outcome was change

2019 EvidenceUpdates

131. Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled Full Text available with Trip Pro

reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area (...) Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat

2019 EvidenceUpdates

132. Cardiovascular safety of linagliptin compared with other oral glucose-lowering agents in patients with type 2 diabetes: A sequential monitoring programme in routine care (Abstract)

Cardiovascular safety of linagliptin compared with other oral glucose-lowering agents in patients with type 2 diabetes: A sequential monitoring programme in routine care To evaluate the safety of linagliptin versus other glucose-lowering medications in a multi-year monitoring programme using insurance claims data.In two commercial US claims databases, we identified three pairwise 1:1 propensity-score (PS)-matched cohorts of patients with type 2 diabetes (T2D) aged ≥18 years initiating

2019 EvidenceUpdates

133. Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, plac Full Text available with Trip Pro

Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, plac In patients with type 2 diabetes, 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 type 2 diabetes 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 type 2 diabetes

2019 EvidenceUpdates

134. Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes

://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 13Contents Contents 1 Recommendations 4 2 Information about ertugliflozin 5 3 Committee discussion 6 Clinical need and current management 6 Clinical evidence 8 Company's economic analysis 10 4 Appraisal committee members and NICE project team 12 Appraisal committee members 12 NICE project team 12 Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes (TA583) © NICE 2019. All rights reserved. Subject (...) to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 131 1 Recommendations Recommendations 1.1 Ertugliflozin with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor is recommended as an option for treating type 2 diabetes in adults when diet and exercise alone do not provide adequate glycaemic control, only if: the disease is uncontrolled with metformin and a DPP-4 inhibitor, and a sulfonylurea or pioglitazone is not appropriate. 1.2 If patients

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

135. Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues

Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues Dec2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 EUnetHTA Joint Action 3 WP4 Version 1.3, 7 th June 2019 Relative effectiveness assessment of pharmaceutical technologies SOTAGLIFLOZIN IS 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 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

2019 EUnetHTA

136. Sotagliflozin (Zynquista) - type 1 diabetes

Sotagliflozin (Zynquista) - type 1 diabetes Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. EMA/224114/2019 EMEA/H/C/004889 Zynquista (sotagliflozin) An overview of Zynquista (...) 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

2019 European Medicines Agency - EPARs

137. Take Control: A randomized trial evaluating the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes Full Text available with Trip Pro

Take Control: A randomized trial evaluating the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes To compare the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL (Gla-300) in people with inadequately controlled type 2 diabetes.Take Control (EudraCT number: 2015-001626-42) was a 24-week, multi-national, open-label, controlled, two-arm, parallel-group study (...) in insulin-naïve and pre-treated participants, randomized 1:1 to a self- or physician-managed titration of Gla-300. The fasting self-monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant-reported outcomes (PROs).At week 24, the least squares (LS) mean HbA1c

2019 EvidenceUpdates

138. Antihyperglycemic and Blood Pressure Effects of Empagliflozin in Black Patients With Type 2 Diabetes Mellitus and Hypertension Full Text available with Trip Pro

Antihyperglycemic and Blood Pressure Effects of Empagliflozin in Black Patients With Type 2 Diabetes Mellitus and Hypertension Empagliflozin, a sodium-glucose cotransporter 2 inhibitor indicated for type 2 diabetes mellitus (T2DM), can lower blood pressure (BP) and reduce cardiovascular mortality in patients with T2DM and preexisting cardiovascular disease. Its effects in blacks have been understudied.In this 24-week study, 150 blacks with T2DM and hypertension had glycohemoglobin (primary end

2019 EvidenceUpdates

139. Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7) Full Text available with Trip Pro

Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7) The aim of this study was to describe the risks of cardiovascular (CV) events and severe hypoglycaemia with insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) aged 65 years or older.A total of 7637 patients in the DEVOTE trial, a treat (...) . The effects across age groups of degludec vs glargine U100 on MACE, all-cause mortality and severe hypoglycaemia were comparable, suggesting that the risk of MACE, as well as all-cause mortality, is similar and the risk of severe hypoglycaemia is lower with degludec regardless of age. Evidence is conclusive only until 74 years of age.© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

2019 EvidenceUpdates

140. Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes (Abstract)

Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public (...) hospital clinics.This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively

2019 EvidenceUpdates