Keto vs Plant-Based Eating: Is the Carb-Insulin Model Correct? "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. 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). Please confirm that you would like to log out of Medscape. In the phase IIIb Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, once-weekly semaglutide (Ozempic) reduced HbA1c by … The key CV outcome results are summarized in Table 1. 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. As expected, gastrointestinal adverse events were more common with semaglutide, while infections were more common for canagliflozin. Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" All patients were considered to have uncontrolled diabetes with an HbA1c of 7-10.5% on stable daily metformin. "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. modified in position 8 to reduce degradation by dipep-tidyl peptidase-4 (DPP-4). 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. "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. 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. 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%. 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. Commenting is limited to medical professionals. SUSTAIN-6 was part of the global phase 3a trial programme for semaglutide, which included six sepa-rate clinical trials of over 7000 patients. 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). 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. 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… 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. Please use this form to submit your questions or comments on how to make this article more useful to clinicians. 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.". 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. 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. 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. In the study — funded by Novo Nordisk, the maker of semaglutide — subcutaneous semaglutide led to a reduction in mean HbA1c of 1.5% compared to 1.0% with canagliflozin from a baseline of 8.3% over the 1-year study. Send comments and news tips to news@medscape.net. Staff Writer, MedPage Today Please see our. To comment please, Comments on Medscape are moderated and should be professional in tone and on topic. 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. 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. 16-31. Intra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. 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. Type 2 diabetes (T2D) is a complex disorder that requires individualized treatment strategies. Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes - SUSTAIN-6. 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. 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. 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. For more diabetes and endocrinology news, follow us on Twitter and Facebook. 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. Learn More. 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. 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 … 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). Lancet Diabetes Endocrinol 2019; DOI: 10.1016/S2213-8587(19)30310-9. 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. 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 . 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. Ashley N. says “I love the respect this company shows me and my body, and more importantly, all women and women’s bodies. What Comes After Metformin in Type 2 Diabetes? SUSTAIN-6 was a randomised, double-blind, placebo-controlled, parallel-group trial of 3297 patients at 230 sites in 20 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 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). Phase 3 CV Outcomes Trial: SUSTAIN 6 Methods. 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). 8,9 In conclusion, the SUSTAIN 10 results support semaglutide as a favourable treatment option in clinical practice. by The quality of … SUSTAIN 8 was a 52-week, phase 3b, randomised, double-blind, double-dummy, active-comparator, two-arm, parallel-group trial. They Love Us. 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). Freelance writer, MedscapeDisclosure: Becky McCall has disclosed no relevant financial relationships. Presented September 17, 2019. When used in containers the nutrient release profile is 45 days (at 25°C / 70°F). The trial was simultaneously published in Lancet Diabetes & Endocrinology. Suståne 8-4-4 is composed of aerobically composted turkey litter, feather meal, and sulfate of potash. SUSTAIN 8, the ongoing phase 3b trial in which semaglutide is being compared with the SGLT2i canagliflozin, should provide more robust data. 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. Abstract, Editorial. You've successfully added to your alerts. Scheen reported working as a clinical investigator in the CANVAS-R trial with canagliflozin and in the PIONEER 7 trial with oral semaglutide. Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. Sep 16, 2016 . The median duration of exposure was 21.6 months in SUSTAIN 6 and 15.9 months in PIONEER 6. Abstract 52. "Presumably, this difference in cost will remain with the oral formulation of semaglutide?" Lingvay reported relationships with Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GI Dynamics, Intarcia, Mannkind, Merck, Mylan, Novartis, Pfizer, Sanofi, TARGET PharmaSolutions, and Valeritas. Click the topic below to receive emails when new articles are available. 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. Burnout Might Really Be Depression; How Do Doctors Cope? This trial is conducted in Africa, Asia, Europe, North and South America. 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 , , , , , , . Our commitment to reproductive health. "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. "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. 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. September 20, 2019. 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) … However, the cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries, he writes. All rights reserved. Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 8 trial, European Association for the Study of Diabetes. 1,2 Approximately 3 out of 4 patients were able to achieve A1C <7% with Ozempic ® 1 mg. 1 But for those with atherosclerotic heart disease, a GLP-1 receptor agonist should be the preferred choice, says Scheen. A total of 739 individuals with type 2 diabetes were included in the 111-center trial. 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. Subjects were grouped according to gender, age (50–65 … EASD 2019 Annual Meeting. Key Results. The primary composite . Semaglutide is a new GLP-1 analog for the once-weekly treatment of T2D. Source Reference: Scheen A "SGLT2 inhibitor or GLP-1 receptor agonist in type 2 diabetes?" European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. Please enter a Recipient Address and/or check the Send me a copy checkbox. The session will feature an update on SUSTAIN 6 (Semaglutide in Subjects with … "The cost of subcutaneous semaglutide is higher than the cost of canagliflozin, which might be a concern in many countries. 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 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. 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.). he wondered. 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. "Beyond effects on HbA1c and bodyweight, consideration should also be given to patient preference, individual tolerance profile, and cost," he said. 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. 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%. This website also contains material copyrighted by 3rd parties. 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. "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.
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