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Latest & greatest articles for type 2 diabetes
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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
Dapagliflozin and Cardiovascular Outcomes in Patients With Type2Diabetes Mellitus and Previous Myocardial Infarction Sodium glucose transporter-2 inhibitors reduce the risk of major adverse cardiovascular events (MACE) in patients with type2diabetes 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 type2diabetes 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
Effect of Dapagliflozin on Heart Failure and Mortality in Type2Diabetes 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 type2diabetes mellitus. However, the impact of baseline left ventricular ejection fraction (EF) on the clinical (...) with type2diabetes 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.
Safety and Effectiveness of Bexagliflozin in Patients With Type2Diabetes 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 type2diabetes and CKD.Phase 3, double-blind, placebo-controlled, multicenter, multinational, randomized trial.54 sites across 4 countries. Patients with CKD stage 3a or 3b, type2diabetes 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
Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type2diabetes 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 (...) reduction and glycaemic control among Japanese patients with type2diabetes 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
Cardiovascular safety of linagliptin compared with other oral glucose-lowering agents in patients with type2diabetes: 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 type2diabetes (T2D) aged ≥18 years initiating
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
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
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 type2diabetes 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 type2 diabetes.Take Control (EudraCT number: 2015-001626-42) was a 24-week, multi-national, open-label, controlled, two-arm, parallel-group study (...) incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self-management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self-managed group.Self-managed titration of Gla-300 was superior to physician-managed titration in terms of HbA1c reduction, accompanied
Antihyperglycemic and Blood Pressure Effects of Empagliflozin in Black Patients With Type2Diabetes Mellitus and Hypertension Empagliflozin, a sodium-glucose cotransporter 2 inhibitor indicated for type2diabetes 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 (...) point), office and 24-hour ambulatory BP, body weight, and safety assessments. After a 2-week, open-label, placebo run-in, patients were randomly assigned to once daily empagliflozin (10 mg for the first 4 weeks, then force-titrated to 25 mg until week 24) or placebo. A mixed-effects model for repeated measures was performed on the primary and 2 key secondary end points, and an analysis of covariance for nonrepeated measures with last observation carried forward was performed for 2 other key
Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type2Diabetes African Americans suffer more than non-Hispanic whites from type2diabetes, 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
Fixed-ratio combination of insulin degludec and liraglutide (IDegLira) improves cardiovascular risk markers in patients with type2diabetes uncontrolled on basal insulin In this post hoc analysis we investigated the effects of insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus comparators on cardiovascular (CV) risk markers in participants in the DUAL II (vs. insulin degludec), DUAL V (vs. insulin glargine 100 units/mL) and DUAL VII (vs. basal-bolus therapy) trials, grouped (...) by sex, age (<65 years, ≥65 years) and diabetes duration (<10 years, ≥10 years). Treatment contrasts were in favour of IDegLira in many subgroups for changes from baseline in glycated haemoblogin (DUAL II, DUAL V), body weight (all three trials), systolic blood pressure (BP; all three trials), HDL cholesterol (DUAL VII) and LDL cholesterol (DUAL II, DUAL V). Higher heart rates were seen with IDegLira versus comparators (all three trials) plus significantly higher diastolic BP in men (DUAL V
Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type2diabetes To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add-on to sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy.In this 26-week, phase IIIb, open-label, parallel-group, treat-to-target trial (...) , conducted at 74 sites in 11 countries, insulin-naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53-97 mmol/mol (7.0-11.0%), body mass index 20-40 kg/m2 and inadequately controlled type2diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once-daily IDegLira or IGlar U100, both as add-on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26.A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions
Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type2diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial To assess the efficacy and safety of twice-daily insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart 30 (BIAsp 30) twice daily, both ± metformin, in Chinese adults (N = 543) with type2diabetes (T2D) inadequately controlled on premixed/self-mixed or basal insulin ± metformin.We (...) conducted a 26-week, phase III, open-label, treat-to-target, 2:1 randomized trial. Hierarchical testing was used with non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 26 as the primary endpoint and superiority for the confirmatory secondary endpoints which were as follows: change from baseline in fasting plasma glucose (FPG); nocturnal confirmed hypoglycaemic episodes (12:01-5:59 am, inclusive); total confirmed hypoglycaemic episodes (severe or plasma glucose <3.1 mmol/L
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
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