Source Reference: Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" The primary composite . by 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. Key Results. "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. 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. 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. For more diabetes and endocrinology news, follow us on Twitter and Facebook. 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.). The quality of … All material on this website is protected by copyright, Copyright © 1994-2021 by WebMD LLC. 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. 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 … 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. 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. In the phase IIIb Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, once-weekly semaglutide (Ozempic) reduced HbA1c by … 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. Semaglutide is a new GLP-1 analog for the once-weekly treatment of T2D. Please enter a Recipient Address and/or check the Send me a copy checkbox. 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. 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. Our commitment to reproductive health. Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. 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. Staff Writer, MedPage Today SUSTAIN-6 was a randomised, double-blind, placebo-controlled, parallel-group trial of 3297 patients at 230 sites in 20 Please confirm that you would like to log out of Medscape. Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" 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. Burnout Might Really Be Depression; How Do Doctors Cope? 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. In an interview with Medscape Medical News at EASD, Hertzel Gerstein, MD, McMaster University and Hamilton Health Sciences, Ontario, Canada, agreed. 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). Is Type 2 Diabetes Linked to Increased Risk of Rheumatoid Arthritis? 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. But for those with atherosclerotic heart disease, a GLP-1 receptor agonist should be the preferred choice, says Scheen. The effects of gender, age and baseline CV risk on outcomes are important considerations for further study. 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. Abstract, Editorial. SUSTAIN 8, the ongoing phase 3b trial in which semaglutide is being compared with the SGLT2i canagliflozin, should provide more robust data. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. 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. Published online September 17, 2019. 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. What Comes After Metformin in Type 2 Diabetes? Type 2 diabetes (T2D) is a complex disorder that requires individualized treatment strategies. modified in position 8 to reduce degradation by dipep-tidyl peptidase-4 (DPP-4). Sep 16, 2016 . "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. Both treatments were generally well-tolerated. Also, significantly more patients treated with semaglutide achieved a 10% or greater reduction in body weight versus canagliflozin (22.3% vs 8.9%). EASD 2019 Annual Meeting. Fast Five Quiz: How Well Do You Know the Risk Factors and Treatment Indications for Type 2 Diabetes Mellitus? Share cases and questions with Physicians on Medscape Consult. 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. 8,9 In conclusion, the SUSTAIN 10 results support semaglutide as a favourable treatment option in clinical practice. © 2021 MedPage Today, LLC. The trial was conducted at 111 centres in 11 countries. 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%. Glucagon-like peptide-1 re… Magicka Warden damage dealers are often shunned in endgame trial content. This post-hoc analysis assessed the effect of semaglutide on renal function by baseline eGFR in the SUSTAIN 6 trial. 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. 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 … You will receive email when new content is published. 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). Freelance writer, MedscapeDisclosure: Becky McCall has disclosed no relevant financial relationships. "Presumably, this difference in cost will remain with the oral formulation of semaglutide?" "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. "In patients with type 2 diabetes and very high risk of cardiovascular (and renal) disease, 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, considering the positive results on surrogate endpoints reported in the SUSTAIN 9 trial with the addition of semaglutide once weekly to an SGLT2 inhibitor," he said. 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. SUSTAIN 8 was a 52-week, phase 3b, randomised, double-blind, double-dummy, active-comparator, two-arm, parallel-group trial. They Love Us. he wondered. 16-31. This website also contains material copyrighted by 3rd parties. 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. All patients were considered to have uncontrolled diabetes with an HbA1c of 7-10.5% on stable daily metformin. We donate 1% of all sales to support women's healthcare organizations in the U.S. 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 key CV outcome results are summarized in Table 1. Lingvay reported relationships with Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GI Dynamics, Intarcia, Mannkind, Merck, Mylan, Novartis, Pfizer, Sanofi, TARGET PharmaSolutions, and Valeritas. Phase 3 CV Outcomes Trial: SUSTAIN 6 Methods. Intra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, European Association for the Study of Diabetes. Send comments and news tips to news@medscape.net. 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). MACE outcome was observed in 108 of 1648 patients (6.6%) and 146 of 1649 (8.9%) patients in the semaglu- Scheen reported working as a clinical investigator in the CANVAS-R trial with canagliflozin and in the PIONEER 7 trial with oral semaglutide. Suståne 8-4-4 All Natural is available in both fine and medium particle sizes. 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. 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). 1,2 Approximately 3 out of 4 patients were able to achieve A1C <7% with Ozempic ® 1 mg. 1 SUSTAIN 8 and 10 were both funded by Novo Nordisk. 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. 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. You've successfully added to your alerts. 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. 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. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. 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. Our findings are consistent with those of previous trials in the SUSTAIN programme, As expected, gastrointestinal adverse events were more common with semaglutide, while infections were more common for canagliflozin. Scheen emphasizes in his editorial that, according to current recommendations (American Diabetes Association and EASD), the presence of comorbidities such as heart failure and renal disease should help steer physicians towards prescribing an SGLT2 inhibitor rather than a GLP-1 receptor agonist as second-line therapy in type 2 diabetes. Ashley N. says “I love the respect this company shows me and my body, and more importantly, all women and women’s bodies. Please see our. Commenting is limited to medical professionals. If you log out, you will be required to enter your username and password the next time you visit. "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. 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]). Subjects were grouped according to gender, age (50–65 … 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). 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) … Keto vs Plant-Based Eating: Is the Carb-Insulin Model Correct? "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. Abstract 52. 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. 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). 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: 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. Gerstein agrees: "Renal disease, glomerular filtration rate, and history of other medical events, for example, whether they've had heart failure or not, might push towards an SGLT2 inhibitor.". 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). However, the cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries, he writes. The session will feature an update on SUSTAIN 6 (Semaglutide in Subjects with … These include André Scheen, MD, from the University of Liège, Belgium, who penned an editorial accompanying, also published in Lancet Diabetes & Endocrinology. Kristen Monaco, "Beyond effects on HbA1c and bodyweight, consideration should also be given to patient preference, individual tolerance profile, and cost," he said. Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes - SUSTAIN-6. 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. 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. September 20, 2019. Nevertheless, there may even be a place for using both together in patients at high risk of cardiovascular and renal disease. All rights reserved. Suståne 8-4-4 is composed of aerobically composted turkey litter, feather meal, and sulfate of potash. A total of 739 individuals with type 2 diabetes were included in the 111-center trial. You must declare any conflicts of interest related to your comments and responses. 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. When used in containers the nutrient release profile is 45 days (at 25°C / 70°F). 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). Presented September 17, 2019. 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. 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. "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. "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. Other physicians stressed the need to take into account a wide range of factors before deciding which type 2 diabetes drug to use as add-on therapy to metformin for any one particular patient. 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. Learn More. 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 . 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. European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. 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. 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). Half the participants were randomized to receive 1.0 mg of once-weekly injectable semaglutide or 300 mg of oral canagliflozin. 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 , , , , , , .