Patients on semaglutide also had a drop of 8.44 pounds (95% CI -10 to -6.6 lb; -3.83 kg, 95% CI −4.57 to −3.0 kg) in body weight versus liraglutide, the researchers reported, adding, however, that those on semaglutide had more commonly occurring gastrointestinal adverse events versus liraglutide. For more diabetes and endocrinology news, follow us on Twitter and Facebook. Scheen reported working as a clinical investigator in the CANVAS-R trial with canagliflozin and in the PIONEER 7 trial with oral semaglutide. The primary composite . 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. 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. 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. Trial designs and endpoints for the SUSTAIN and PIONEER phase 3a glycaemic efficacy trials (SUSTAIN 1–5 and two SUSTAIN JAPAN trials, and PIONEER 1–5, 7–8 and the two PIONEER Japanese trials [9 and 10]) are summarized in Tables S2 and S3, and have also been reported previously. MACE outcome was observed in 108 of 1648 patients (6.6%) and 146 of 1649 (8.9%) patients in the semaglu- What Comes After Metformin in Type 2 Diabetes? 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. Click the topic below to receive emails when new articles are available. Intra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. Magicka Warden damage dealers are often shunned in endgame trial content. Send comments and news tips to news@medscape.net. Abstract, Editorial. All material on this website is protected by copyright, Copyright © 1994-2021 by WebMD LLC. SUSTAIN 8, the ongoing phase 3b trial in which semaglutide is being compared with the SGLT2i canagliflozin, should provide more robust data. 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. Ashley N. says “I love the respect this company shows me and my body, and more importantly, all women and women’s bodies. "The cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries. "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. "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. outcomes of the SUSTAIN-6 trial. Kristen Monaco, 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. 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. Share cases and questions with Physicians on Medscape Consult. Also presented at the EASD meeting, the phase IIIb SUSTAIN 10 trial found that semaglutide was superior to the GLP-1 RA liraglutide (Victoza) for HbA1c and body weight reduction. 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 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. The median duration of exposure was 21.6 months in SUSTAIN 6 and 15.9 months in PIONEER 6. 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). You will receive email when new content is published. Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30310-9. 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. 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. 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. All rights reserved. The main issue stems from sustain issues that are severely holding them back from reaching their DPS potential; in patches where they are able to sustain like resorting to using blood for blood, they are otherwise quite up there. 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… 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 … Presumably, this difference in cost will remain with the oral formulation of semaglutide," he wrote. 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 … 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. Please confirm that you would like to log out of Medscape. Please see our. Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, European Association for the Study of Diabetes. Please enter a Recipient Address and/or check the Send me a copy checkbox. 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. Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30310-9. © 2021 MedPage Today, LLC. 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. "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. Dr. Green is part of the Scientific Sessions Meeting Planning Committee, planning sessions in the area of macrovascular complications . Suståne 8-4-4 is composed of aerobically composted turkey litter, feather meal, and sulfate of potash. SUSTAIN 8 was a 52-week, phase 3b, randomised, double-blind, double-dummy, active-comparator, two-arm, parallel-group trial. In both the CVOTs, trial completion rate was high (SUSTAIN 6: 97.6%; PIONEER 6: 99.7%) with vital status at end-of-trial known for 99.6% of patients in SUSTAIN 6 and 100% in PIONEER 6. 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). 16-31. Half the participants were randomized to receive 1.0 mg of once-weekly injectable semaglutide or 300 mg of oral canagliflozin. 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. Our commitment to reproductive health. Fast Five Quiz: How Well Do You Know the Risk Factors and Treatment Indications for Type 2 Diabetes Mellitus? Keto vs Plant-Based Eating: Is the Carb-Insulin Model Correct? Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes - SUSTAIN-6. Sep 16, 2016 . This trial is conducted in Africa, Asia, Europe, North and South America. Freelance writer, MedscapeDisclosure: Becky McCall has disclosed no relevant financial relationships. EASD 2019 Annual Meeting. Key Results. SUSTAIN-6 was part of the global phase 3a trial programme for semaglutide, which included six sepa-rate clinical trials of over 7000 patients. European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. Both treatments were generally well-tolerated. If you log out, you will be required to enter your username and password the next time you visit. Semaglutide is a new GLP-1 analog for the once-weekly treatment of T2D. "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. Phase 3 CV Outcomes Trial: SUSTAIN 6 Methods. A total of 739 individuals with type 2 diabetes were included in the 111-center trial. Regarding adverse events, 76% of patients on semaglutide experienced any form of adverse events vs 72% of canagliflozin patients, while 5% of both treatment groups had a serious adverse event, the researchers reported. Our findings are consistent with those of previous trials in the SUSTAIN programme, 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 . As expected, gastrointestinal adverse events were more common with semaglutide, while infections were more common for canagliflozin. 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. All patients were considered to have uncontrolled diabetes with an HbA1c of 7-10.5% on stable daily metformin. Patients were screened by investigators at 115 sites, and the trial was done at 111 centres (hospitals and specialised research centres) in 11 countries (Argentina, Brazil, Canada, India, Ireland, Lebanon, Malaysia, Mexico, Sweden, the UK, and the USA). These include André Scheen, MD, from the University of Liège, Belgium, who penned an editorial accompanying, also published in Lancet Diabetes & Endocrinology. Throughout the 30-week trial, the results of which were simultaneously published in Diabetes & Metabolism, those on 1.0 mg of once-weekly semaglutide had a 1.7% mean HbA1c decrease vs a drop of 1.0% for those on 1.2 mg of once-daily injectable liraglutide. Also, significantly more patients treated with semaglutide achieved a 10% or greater reduction in body weight versus canagliflozin (22.3% vs 8.9%). 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). When used in containers the nutrient release profile is 45 days (at 25°C / 70°F). Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" Is Type 2 Diabetes Linked to Increased Risk of Rheumatoid Arthritis? Type 2 diabetes (T2D) is a complex disorder that requires individualized treatment strategies. Suståne 8-4-4 All Natural is available in both fine and medium particle sizes. But for those with atherosclerotic heart disease, a GLP-1 receptor agonist should be the preferred choice, says Scheen. "Presumably, this difference in cost will remain with the oral formulation of semaglutide?" Please use this form to submit your questions or comments on how to make this article more useful to clinicians. Nevertheless, there may even be a place for using both together in patients at high risk of cardiovascular and renal disease. Glucagon-like peptide-1 re… Those on canagliflozin also saw a slight drop in pulse rate (-0.6 beats/min), while those on semaglutide had a slight increase (2.7 beats/min). Lancet. As well as the significantly greater reduction in HbA1c with semaglutide compared with canagliflozin — a treatment difference of 0.5 percentage points (P < .0001) — 66.1% versus 45.1% achieved an HbA1c < 7%. 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. 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. "Beyond effects on HbA1c and bodyweight, consideration should also be given to patient preference, individual tolerance profile, and cost," he said. 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. SUSTAIN-6 was a randomised, double-blind, placebo-controlled, parallel-group trial of 3297 patients at 230 sites in 20 You've successfully added to your alerts. But data comparing the two drugs classes head-to-head in patients inadequately controlled with metformin are lacking, with just one prior study comparing the new oral formulation of semaglutide — just approved by the FDA — with the SGLT2 inhibitor empagliflozin (Jardiance, Lilly/Boehringer Ingelheim). 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. Commenting is limited to medical professionals. The effects of gender, age and baseline CV risk on outcomes are important considerations for further study. modified in position 8 to reduce degradation by dipep-tidyl peptidase-4 (DPP-4). 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. This trial is conducted in Asia, Europe and the United States of America (USA). SUSTAIN 8 and 10 were both funded by Novo Nordisk. Learn More. One of the macrovascular sessions she said she’s looking forward to is titled Update on Cardiovascular Outcomes Trials (CVOTs) on Friday, June 9 (2:00 p.m.–4:00 p.m.). 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]). 1,2 Approximately 3 out of 4 patients were able to achieve A1C <7% with Ozempic ® 1 mg. 1 "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. Subjects were grouped according to gender, age (50–65 … 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. Findings of the 52-week double-blind trial were presented at the European Association for the Study of Diabetes (EASD) meeting and simultaneously published in The Lancet Diabetes & Endocrinology. The trial was simultaneously published in Lancet Diabetes & Endocrinology. Staff Writer, MedPage Today In an interview with Medscape Medical News at EASD, Hertzel Gerstein, MD, McMaster University and Hamilton Health Sciences, Ontario, Canada, agreed. The trial was conducted at 111 centres in 11 countries. 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) … 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. 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). They Love Us. 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. "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. The primary endpoint was change in HbA1c from baseline to week 52, and key secondary endpoints included change in body weight and total fat mass, as well as the proportion of patients achieving HbA1c < 7.0%. "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. Presented September 17, 2019. Lingvay reported relationships with Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GI Dynamics, Intarcia, Mannkind, Merck, Mylan, Novartis, Pfizer, Sanofi, TARGET PharmaSolutions, and Valeritas. However, the cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries, he writes. Source Reference: Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" 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). Cite this: SUSTAIN-8: Semaglutide vs Canagliflozin After Metformin in T2D - Medscape - Sep 23, 2019. Source Reference: 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. "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. The first 8 weeks was a dose-titration phase, followed by 44 weeks of treatment maintenance and 5 weeks of follow-up. 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). Burnout Might Really Be Depression; How Do Doctors Cope? Abstract 52. September 20, 2019. This post-hoc analysis assessed the effect of semaglutide on renal function by baseline eGFR in the SUSTAIN 6 trial. Briefly, SUSTAIN 8 was a 52- week, Phase IIIB randomised double-blind, double-dummy, parallel-group trial of once-weekly semaglutide 1.0 mg vs once-daily canagliflozin 300 mg in 788 adults with type 2 diabetes on stable treatment with metformin. The session will feature an update on SUSTAIN 6 (Semaglutide in Subjects with … 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. In the phase IIIb Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, once-weekly semaglutide (Ozempic) reduced HbA1c by … he wondered. "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.
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