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In addition to the A1c benefit, those on semaglutide had a significant reduction in fasting plasma glucose, an average seven-point self-measured blood glucose (SMBG) profile, as well as postprandial SMBG. Lingvay reported that SUSTAIN-8 was a 52-week, double-blind, parallel-group, randomized controlled phase 3 trial conducted across 11 countries investigating the efficacy and safety of once-weekly subcutaneous semaglutide (1.0 mg) versus canagliflozin (300 mg daily) as add-on to metformin in people with type 2 diabetes. But for those with atherosclerotic heart disease, a GLP-1 receptor agonist should be the preferred choice, says Scheen. 1,2 Approximately 3 out of 4 patients were able to achieve A1C <7% with Ozempic ® 1 mg. 1 The primary composite . Intra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. Lingvay reported relationships with Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GI Dynamics, Intarcia, Mannkind, Merck, Mylan, Novartis, Pfizer, Sanofi, TARGET PharmaSolutions, and Valeritas. The SUSTAIN 6 trial demonstrated that once-weekly semaglutide (0.5 and 1.0 mg) significantly reduced major adverse cardiovascular (CV) events (MACE) vs placebo in subjects with type 2 diabetes (T2D) and high CV risk. The trial was simultaneously published in Lancet Diabetes & Endocrinology. When used in containers the nutrient release profile is 45 days (at 25°C / 70°F). Ashley N. says “I love the respect this company shows me and my body, and more importantly, all women and women’s bodies. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 3 trial is a phase 3a comparative study that evaluated the efficacy, safety, and tolerability of once-weekly semaglutide 1.0 mg s.c. versus that of once-weekly exenatide ER 2.0 mg s.c. over 56 weeks in adults with type 2 diabetes who are inadequately controlled on oral antidiabetic drugs (OADs). The key CV outcome results are summarized in Table 1. Source Reference: Lingvay I, et al "Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial" Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30311-0. Capehorn M, et al "Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1–3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10)" Diabetes Metab 2019; DOI: 10.1016/j.diabet.2019.101117. Regulatory guidance specifies the need to establish the cardiovascular safety of new therapies for type 2 diabetes in order to rule out excess cardiovascular risk.5 The preapproval Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Dia… Source Reference: Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" SUSTAIN-6 was a randomised, double-blind, placebo-controlled, parallel-group trial of 3297 patients at 230 sites in 20 "SUSTAIN 8 provides clinically relevant information regarding the head-to-head comparison of these two very commonly used glucose-lowering classes as second-line therapy in patients with type 2 diabetes," Lingvay stated during an oral presentation of the findings. "Therefore, the main conclusion of Lingvay and colleagues that 'these outcomes might guide treatment intensification choices' might be questioned from a clinical relevance point of view," Scheen said. Staff Writer, MedPage Today Mean body weight (baseline 96.9kg) decreased by 5.8kg with semaglutide and 1.9kg with liraglutide (ETD -3.83kg; 95% CI -4.57 to -3.09, P<0.0001). Obesity: How to Diagnose and Treat an Epidemic, Diabetes Mellitus Type 2 News & Perspectives, Risk Factors for the Development of Hepatocellular Carcinoma (HCC) in Chronic Hepatitis B Virus (HBV) Infection. September 20, 2019. Kristen Monaco, Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, European Association for the Study of Diabetes. Magicka Warden damage dealers are often shunned in endgame trial content. And because data show that GLP-1 agonists and SGLT2 inhibitors cause weight loss and lead to improvements in cardiovascular outcomes, as well as lower HbA1c, the two drug classes are increasingly being used as preferred second-line agents after metformin. modified in position 8 to reduce degradation by dipep-tidyl peptidase-4 (DPP-4). Is Type 2 Diabetes Linked to Increased Risk of Rheumatoid Arthritis? Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. Because of its progressive nature, many individuals receiving basal insulin require intensification of therapy to maintain optimal glycemic control and to reduce the risk of complications (1–5). 8,9 In conclusion, the SUSTAIN 10 results support semaglutide as a favourable treatment option in clinical practice. Although increasing the basal insulin dose and/or adding mealtime insulin is often effective, this approach can increase the risk of hypoglycemia and lead to weight gain in an often overweight population (6). European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. Type 2 diabetes (T2D) is a complex disorder that requires individualized treatment strategies. Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin This study aimed to compare the effects of semaglutide 1.0 mg and canagliflozin 300 mg on body composition in a subset of participants from the SUSTAIN 8 Phase IIIB, randomised double-blind trial who underwent whole-body dual-energy x-ray absorptiometry (DXA) … Lingvay I, et al "Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial" Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30311-0. The effects of gender, age and baseline CV risk on outcomes are important considerations for further study. A total of 739 individuals with type 2 diabetes were included in the 111-center trial. However, those on canagliflozin saw a greater drop in systolic and diastolic blood pressure (SBP: -3.5 vs -5.5 mmHg; DBP: -1.0 vs -3.0 mmHg). As expected, gastrointestinal adverse events were more common with semaglutide, while infections were more common for canagliflozin. Black-and-white clinical decisions in the future may not ultimately lie in choosing between these two popular classes of glucose-lowering agents, as more and more evidence is coming out in support of combination therapies, Scheen added. Cite this: SUSTAIN-8: Semaglutide vs Canagliflozin After Metformin in T2D - Medscape - Sep 23, 2019. Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30310-9. Our findings are consistent with those of previous trials in the SUSTAIN programme, These findings are consistent with those from the SUSTAIN 3 and 7 trials, which compared semaglutide with other GLP-1RA (exenatide extended release and dulaglutide, respectively). Results: Mean HbA 1c (baseline 8.2%) decreased by 1.7% with semaglutide and 1.0% with liraglutide (estimated treatment difference [ETD] -0.69%; 95% confidence interval [CI] -0.82 to -0.56, P<0.0001). SUSTAIN 8, the ongoing phase 3b trial in which semaglutide is being compared with the SGLT2i canagliflozin, should provide more robust data. SUSTAIN 8: Semaglutide outperforms canagliflozin as second-line therapy for type 2 diabetes medwireNews : Treatment with the glucagon-like peptide (GLP)-1 receptor agonist semaglutide results in better glycemic control than the sodium-glucose cotransporter (SGLT)2 inhibitor canagliflozin among people with type 2 diabetes uncontrolled on metformin, indicate the SUSTAIN 8 trial results. SUSTAIN 8 was a 52-week, phase 3b, randomised, double-blind, double-dummy, active-comparator, two-arm, parallel-group trial. Click the topic below to receive emails when new articles are available. The median duration of exposure was 21.6 months in SUSTAIN 6 and 15.9 months in PIONEER 6. "As a clinician, one usually makes a choice based on the personal story of the patient, combined with history and physical examination, to provide personalized medicine," he observed. Ischemic Stroke May Hint at Underlying Cancer, Topol: US Betrays Healthcare Workers in Coronavirus Disaster, The 6 Dietary Tips Patients Need to Hear From Their Clinicians. "SUSTAIN-8 provides clinically relevant information regarding the head-to-head comparison of these two commonly used glucose-lowering classes as second-line therapy in patients with type 2 diabetes," Lingvay told delegates. However, the cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries, he writes. SUSTAIN 6 compared the long-term safety and efficacy of semaglutide with placebo during 2 years in adults with type 2 diabetes at high risk for CV events . Our commitment to reproductive health. Lancet. Scheen reported working as a clinical investigator in the CANVAS-R trial with canagliflozin and in the PIONEER 7 trial with oral semaglutide. This website also contains material copyrighted by 3rd parties. In the SUSTAIN 7 trial, we evaluated the percentage of patients achieving an A1C <7%, which the ADA recommends as a reasonable goal for most adults. Keto vs Plant-Based Eating: Is the Carb-Insulin Model Correct? Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30310-9. © 2021 MedPage Today, LLC. "Studies show that achieving a target HbA1c of 7.0% or lower is crucial for reducing the development and progression of microvascular complications in type 2 diabetes," said Lingvay. El Dr. Lingvay informó que SUSTAIN-8 era un estudio aleatorizado controlado de fase 3, con grupo paralelo, a doble ciego, de 52 semanas, realizado en 11 países, en el cual se investigaron la eficacia y la tolerabilidad de semaglutida subcutánea una vez a la semana (1,0 mg) frente a canagliflozina (300 mg al día) como tratamiento añadido a metformina en personas con diabetes de tipo 2. "We might speculate about the add-on value of a combination therapy instead of the dilemma of choosing between a GLP-1 receptor agonist and an SGLT2 inhibitor," Scheen concludes. They Love Us. SUSTAIN 8 – Clinical Trial in Type 2 Diabetes Purpose of Study :This trial is looking at the addition of either a once-weekly injectable medication or a tablet for people with type 2 diabetes taking metformin only, to see if blood glucose control can be further improved. Freelance writer, MedscapeDisclosure: Becky McCall has disclosed no relevant financial relationships. Abstract 52. Suståne 8-4-4 is composed of aerobically composted turkey litter, feather meal, and sulfate of potash. You've successfully added to your alerts. Semaglutide is a new GLP-1 analog for the once-weekly treatment of T2D. FDA's Added-Sugar Labeling Policy to Pay Sweet Dividends, VA Tests Keto Diet in Diabetic Patients; Skeptics Raise Red Flags, 'I'm a Survivor': Incoming ADA President Has Type 1 Diabetes, Glucocorticoids Linked to Higher Mortality Rates in Patients with RA and Diabetes, Fast Five Quiz: Type 2 Diabetes Mellitus Comorbidities, Fast Five Quiz: Type 2 Diabetes Mellitus Presentation and Diagnosis. Share cases and questions with Physicians on Medscape Consult. The session will feature an update on SUSTAIN 6 (Semaglutide in Subjects with … Also, significantly more patients treated with semaglutide achieved a 10% or greater reduction in body weight versus canagliflozin (22.3% vs 8.9%). You will receive email when new content is published. This trial is conducted in Africa, Asia, Europe, North and South America. The SUSTAIN-6 trial showed that semaglutide is superior to placebo in improving glycemic control and reducing CV events in patients with DM2 and high CV risk. Semaglutide, a GLP-1 analogue with an extended half-life of approximately 1 week (which permits once-weekly subcutaneous administration),4 is currently in development but not yet approved for the treatment of type 2 diabetes. Sep 16, 2016 . These include André Scheen, MD, from the University of Liège, Belgium, who penned an editorial accompanying, also published in Lancet Diabetes & Endocrinology. If you log out, you will be required to enter your username and password the next time you visit. "The cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries. The decision regarding therapy "depends on many things...including the jurisdiction one is in, which incorporates the cost, and whether [that]...is covered by a third party; the side effect profile; and what the patient wants to take," Gerstein added. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. "In isolation, the trial will not drive therapy towards one agent or the other, but it will inform judgement when a clinician interacts with a patient and is really practicing personalized care," he commented. What Comes After Metformin in Type 2 Diabetes? Both treatments were added to an already existing diabetes regimen of one to three oral antidiabetic agents among the 577 adults included in the trial, which was led by Matthew Capehorn, MBChB, of Clifton Medical Centre in the U.K. Half the participants were randomized to receive 1.0 mg of once-weekly injectable semaglutide or 300 mg of oral canagliflozin. Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes - SUSTAIN-6. All material on this website is protected by copyright, Copyright © 1994-2021 by WebMD LLC. "Overall, the differences between semaglutide and SGLT2 inhibitors regarding these surrogate endpoints remain small, although significant," noted the author of an accompanying commentary, André Scheen, MD, PhD, of Liège University in Belgium. Fast Five Quiz: How Well Do You Know the Risk Factors and Treatment Indications for Type 2 Diabetes Mellitus? Blood Glucose on Admission Predicts COVID-19 Severity in All, Assessing Thyroid Nodules: A Clinician's Guide, FDA OKs 'Game-Changer' Oral GLP-1 Agonist for Type 2 Diabetes. BARCELONA — Only the second head-to-head trial to directly compare two new classes of type 2 diabetes drugs, a GLP-1 agonist with an SGLT2 inhibitor, shows the former, in this case once-weekly subcutaneous semaglutide (Ozempic, Novo Nordisk) was superior to the latter, daily canagliflozin (Invokana, Janssen) in reducing HbA1c and body weight in patients with type 2 diabetes uncontrolled on metformin. The SUSTAIN 9 trial shows that adding semaglutide to existing SGLT-2 inhibitor therapy results in significant and clinically relevant reductions in both HbA 1c and bodyweight, compared with placebo, in patients with uncontrolled type 2 diabetes. The quality of … You must declare any conflicts of interest related to your comments and responses. SUSTAIN-8 Phase 3 Trial Fills Evidence Gap "Studies show that achieving a target HbA 1c of 7.0% or lower is crucial for reducing the development and progression of … All patients were considered to have uncontrolled diabetes with an HbA1c of 7-10.5% on stable daily metformin. In the phase IIIb Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, once-weekly semaglutide (Ozempic) reduced HbA1c by 1.5% versus 1.0% with once-daily canagliflozin (Invokana) (HbA1c estimated treatment difference -0.49%, 95% CI -0.65 to -0.33; -5.34 mmol/mol, 95% CI -7.10 to -3.57), according to Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center in Dallas, and colleagues. The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes. This article is a collaboration between MedPage Today and: BARCELONA -- A glucagon-like peptide (GLP)-1 receptor agonist proved superior for lowering hemoglobin (Hb)A1c compared with a sodium–glucose cotransporter (SGLT)-2 inhibitor in a head-to-head comparison reported here. The SUSTAIN 8 trial – reported in The Lancet Diabetes & Endocrinology – demonstrated a significantly greater reduction in HbA1c levels with semaglutide versus the sodium-glucose cotransporter (SGLT)-2 inhibitor canagliflozin at 1 year, with mean decreases of 1.5% and 1.0%, respectively. Overall, mean eGFR decreased from baseline to week 104 across all treatment groups and subgroups, with the largest decreases in subjects with normal renal function or mild renal impairment ([Figure][1]). Presumably, this difference in cost will remain with the oral formulation of semaglutide," he wrote. All rights reserved. However, he also highlighted that things could shift in favor of semaglutide after its oral form is approved, as only the injectable version is currently available. Presented September 17, 2019. Please confirm that you would like to log out of Medscape. Glucagon-like peptide-1 re… This trial is conducted in Asia, Europe and the United States of America (USA). Phase 3 CV Outcomes Trial: SUSTAIN 6 Methods. SUSTAIN-6 was part of the global phase 3a trial programme for semaglutide, which included six sepa-rate clinical trials of over 7000 patients. Send comments and news tips to news@medscape.net. he wondered. In the SUSTAIN trials semaglutide consistently demonstrated superior reductions in HbA 1c and body weight vs placebo and a range of active comparators, including other GLP-1RAs (exenatide extended release [ER] and dulaglutide) and basal insulin glargine, with a safety profile similar to that of other GLP-1RAs , , , , , , . Participants treated with subcutaneous semaglutide also lost more weight compared with canagliflozin, on average 5.3 kg versus 4.2 kg, from a mean baseline of 90.2 kg. Abstract, Editorial. Burnout Might Really Be Depression; How Do Doctors Cope? In addition to this glucose-lowering benefit, patients on semaglutide also saw a superior reduction in body weight compared with patients on canagliflozin (-2.3 lb, 95% CI -3.88 to -0.79 lb; -1.06 kg, 95% CI -1.76 to -0.36 kg). Lingvay and colleagues analyzed data from the SUSTAIN 8 trial, which included 788 adults (mean age, 56.6 years; 46% women) with type 2 diabetes who were using metformin but … Although serious adverse events were rare for both drugs, almost double the number of patients taking semaglutide versus canagliflozin discontinued treatment, primarily because of gastrointestinal side effects. Both treatments were generally well-tolerated. Please see our. "There are very few head-to-head comparator trials with one [type 2 diabetes] drug class versus the other," said Ildiko Lingvay, MD, from UT Southwestern Medical Center, University of Texas, Dallas, who presented the findings of the SUSTAIN-8 trial here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting.
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