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. SUSTAIN-6 was part of the global phase 3a trial programme for semaglutide, which included six sepa-rate clinical trials of over 7000 patients. 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 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 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. 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). SUSTAIN-6 was a randomised, double-blind, placebo-controlled, parallel-group trial of 3297 patients at 230 sites in 20 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. Scheen reported working as a clinical investigator in the CANVAS-R trial with canagliflozin and in the PIONEER 7 trial with oral semaglutide. 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. 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. EASD 2019 Annual Meeting. 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 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. Abstract, Editorial. You must declare any conflicts of interest related to your comments and responses. Key Results. "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. Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, European Association for the Study of Diabetes. We donate 1% of all sales to support women's healthcare organizations in the U.S. Please enter a Recipient Address and/or check the Send me a copy checkbox. 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. This trial is conducted in Africa, Asia, Europe, North and South America. Freelance writer, MedscapeDisclosure: Becky McCall has disclosed no relevant financial relationships. In the phase IIIb Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, once-weekly semaglutide (Ozempic) reduced HbA1c by … © 2021 MedPage Today, LLC. 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). Please use this form to submit your questions or comments on how to make this article more useful to clinicians. When used in containers the nutrient release profile is 45 days (at 25°C / 70°F). In an interview with Medscape Medical News at EASD, Hertzel Gerstein, MD, McMaster University and Hamilton Health Sciences, Ontario, Canada, agreed. Staff Writer, MedPage Today SUSTAIN 8 and 10 were both funded by Novo Nordisk. 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) … SUSTAIN 8, the ongoing phase 3b trial in which semaglutide is being compared with the SGLT2i canagliflozin, should provide more robust data. Cite this: SUSTAIN-8: Semaglutide vs Canagliflozin After Metformin in T2D - Medscape - Sep 23, 2019. "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. 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. All material on this website is protected by copyright, Copyright © 1994-2021 by WebMD LLC. The session will feature an update on SUSTAIN 6 (Semaglutide in Subjects with … Subjects were grouped according to gender, age (50–65 … 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. 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). modified in position 8 to reduce degradation by dipep-tidyl peptidase-4 (DPP-4). You've successfully added to your alerts. outcomes of the SUSTAIN-6 trial. 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. Magicka Warden damage dealers are often shunned in endgame trial content. 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). Half the participants were randomized to receive 1.0 mg of once-weekly injectable semaglutide or 300 mg of oral canagliflozin. he wondered. 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. Type 2 diabetes (T2D) is a complex disorder that requires individualized treatment strategies. "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. The trial was conducted at 111 centres in 11 countries. The effects of gender, age and baseline CV risk on outcomes are important considerations for further study. All rights reserved. MACE outcome was observed in 108 of 1648 patients (6.6%) and 146 of 1649 (8.9%) patients in the semaglu- Lancet. 16-31. "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. SUSTAIN 8 was a 52-week, phase 3b, randomised, double-blind, double-dummy, active-comparator, two-arm, parallel-group trial. 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 … What Comes After Metformin in Type 2 Diabetes? Click the topic below to receive emails when new articles are available. All patients were considered to have uncontrolled diabetes with an HbA1c of 7-10.5% on stable daily metformin. 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. 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. Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. The quality of … Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" 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. 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. 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. 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. Published online September 17, 2019. 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. Our findings are consistent with those of previous trials in the SUSTAIN programme, Sep 16, 2016 . 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. 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.". "Beyond effects on HbA1c and bodyweight, consideration should also be given to patient preference, individual tolerance profile, and cost," he said. "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. 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. 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. Ashley N. says “I love the respect this company shows me and my body, and more importantly, all women and women’s bodies. "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. Learn More. 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. 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). 8,9 In conclusion, the SUSTAIN 10 results support semaglutide as a favourable treatment option in clinical practice. 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. "Presumably, this difference in cost will remain with the oral formulation of semaglutide?" 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. Glucagon-like peptide-1 re… 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. 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). Presumably, this difference in cost will remain with the oral formulation of semaglutide," he wrote. The median duration of exposure was 21.6 months in SUSTAIN 6 and 15.9 months in PIONEER 6. The first 8 weeks was a dose-titration phase, followed by 44 weeks of treatment maintenance and 5 weeks of follow-up. Keto vs Plant-Based Eating: Is the Carb-Insulin Model Correct? Suståne 8-4-4 is composed of aerobically composted turkey litter, feather meal, and sulfate of potash. 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 … 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. 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. 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. This trial is conducted in Asia, Europe and the United States of America (USA). They Love Us. A total of 739 individuals with type 2 diabetes were included in the 111-center trial. Kristen Monaco, 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.