Rybelsus (semaglutide oral) / Novo Nordisk 
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  • ||||||||||  semaglutide SC once-daily (NN9536) / Novo Nordisk
    Clinical, Journal:  GLP-1 receptor agonists in the treatment of type 2 diabetes: role and clinical experience to date. (Pubmed Central) -  Nov 12, 2020   
    With some patients having a preference for oral medications, the development of an oral GLP-1RA is a logical approach to improving treatment options for patients with T2D. Co-formulation of semaglutide with an absorption enhancer has enabled the development and recent approval of the first oral GLP-1RA, oral semaglutide, which has the potential to expand use of GLP-1RAs in clinical practice.
  • ||||||||||  Rybelsus (semaglutide oral) / Novo Nordisk
    Journal:  Oral Semaglutide: A Review of the First Oral Glucagon-Like Peptide-1 Receptor Agonist. (Pubmed Central) -  Nov 7, 2020   
    The oral formulation of semaglutide was studied in the PIONEER trials, demonstrating similar efficacy to the currently available GLP-1 RAs in regards to HbA1c lowering and weight loss. Although PIONEER 6 trial suggests positive effects on cardiovascular mortality with oral semaglutide, these benefits may not fully be appreciated until the completion of the SOUL trial.
  • ||||||||||  Rybelsus (semaglutide oral) / Novo Nordisk
    Trial initiation date:  Semaglutide for the Treatment of Cognitive Dysfunction in Major Depressive Disorder (clinicaltrials.gov) -  Nov 3, 2020   
    P2,  N=60, Not yet recruiting, 
    Although PIONEER 6 trial suggests positive effects on cardiovascular mortality with oral semaglutide, these benefits may not fully be appreciated until the completion of the SOUL trial. Initiation date: Sep 2020 --> Jan 2021
  • ||||||||||  [VIRTUAL] EFFECTS OF SEMAGLUTIDE VS COMPARATORS ON CARDIOVASCULAR EVENTS ACROSS A CONTINUUM OF BASELINE CARDIOVASCULAR RISK: COMBINED ANALYSIS OF THE SUSTAIN AND PIONEER TRIALS (Inxpo Platform, Simulive + Text Q&A) -  Oct 4, 2020 - Abstract #CCCCanada2020CCC_Canada_90;    
    Fewer major adverse cardiovascular events (MACE) were observed with semaglutide vs placebo in cardiovascular outcomes trials (CVOTs) in subjects with type 2 diabetes (T2D) at high risk of cardiovascular (CV) events (once-weekly subcutaneous semaglutide in SUSTAIN 6; once-daily oral semaglutide in PIONEER 6). To better understand the CV effect of semaglutide in a broader range of subjects with T2D, including those at lower CV risk, we conducted a post hoc analysis of semaglutide and comparator (placebo, sitagliptin, exenatide extended release, insulin glargine, dulaglutide, liraglutide, and empagliflozin) data from all phase 3a SUSTAIN and PIONEER trials across the continuum of baseline CV risk characterizing a broad T2D population.
  • ||||||||||  Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
    Retrospective data, Journal:  GLP-1 receptor agonists for prevention of cardiorenal outcomes in type 2 diabetes: an updated meta-analysis including the REWIND and PIONEER 6 trials. (Pubmed Central) -  Sep 30, 2020   
    GLP-1RA also reduced the risk cardiovascular death by 12%, nonfatal stroke by 16%, hospitalisation for heart failure by 9%, all-cause mortality by 11%, and the broad composite kidney outcome by 17%; the latter appeared to be driven by a reduction in macroalbuminuria only (HR = 0.76, 0.68-0.86, P = 0.003). GLP-1RA have moderate benefits on MACE, and also reduce hospitalisation for heart failure and all-cause mortality; they also have robust benefits on reducing the incidence of macroalbuminuria, without affecting the progression of diabetic renal disease.
  • ||||||||||  semaglutide SC once-daily (NN9536) / Novo Nordisk
    Clinical, Review, Journal:  Incorporating and Interpreting Regulatory Guidance on Estimands in Diabetes Clinical Trials: The PIONEER 1 Randomized Clinical Trial as an Example. (Pubmed Central) -  Sep 9, 2020   
    In PIONEER 1, two estimands were employed for each efficacy endpoint and labelled as: (1) the treatment policy estimand, which assesses the treatment effect regardless of the use of rescue medication or discontinuation of trial product, and provides a broad perspective of the treatment effect in the population of patients with type 2 diabetes in clinical practice; and (2) the trial product estimand, which assesses the treatment effect had all patients remained on trial product for the planned duration of the trial without rescue medication, and thereby provides information on the anticipated treatment effect of the medication. Both approaches are complementary in understanding the effect of the studied treatments.
  • ||||||||||  Rybelsus (semaglutide oral) / Novo Nordisk, metformin / Generic mfg.
    Journal:  Oral Semaglutide: First-in-Class Oral GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes Mellitus. (Pubmed Central) -  Sep 8, 2020   
    Relevance to Patient Care and Clinical Practice: Oral semaglutide may be appropriate as second- or third-line add-on therapy for patients with T2DM who are not meeting treatment goals on metformin and are overweight and reluctant to use an injectable drug. Oral semaglutide appears safe and effective as monotherapy and add-on pharmacological therapy for the treatment of T2DM.
  • ||||||||||  Rybelsus (semaglutide oral) / Novo Nordisk
    Journal, HEOR:  Quantifying the value of orally delivered biologic therapies: A cost-effectiveness analysis of oral semaglutide. (Pubmed Central) -  Aug 23, 2020   
    We conclude that the additional costs incurred to produce extra semaglutide for the oral formulation are cost effective, given the greater quality of life experienced when taking a capsule over a weekly injection. We also demonstrate that the potency of semaglutide allows the formulation to be cost effective, and less potent drugs will require increased oral bioavailability to make a cost effective oral formulation.