- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: QUEST: Lifestyle Counseling and Medication for Adolescent Weight Management (clinicaltrials.gov) - Jan 25, 2022
P2, N=120, Recruiting,
In a Swedish setting, oral semaglutide was cost effective compared with empagliflozin and sitagliptin for patients with T2D inadequately controlled on oral glucose-lowering drugs. Not yet recruiting --> Recruiting
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Rybelsus (Twitter) - Jan 19, 2022
- |||||||||| Januvia (sitagliptin) / Merck (MSD)
New P4 trial: Semaglutide vs Sitagliptin (clinicaltrials.gov) - Jan 19, 2022
P4, N=140, Not yet recruiting,
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Review, Journal: Cardiovascular Safety and Benefits of Semaglutide in Patients With Type 2 Diabetes: Findings From SUSTAIN 6 and PIONEER 6. (Pubmed Central) - Jan 8, 2022
P3
Surprisingly, CV and all-cause mortality were significantly reduced by oral semaglutide in PIONEER 6...Findings from SUSTAIN 6 and PIONEER 6 fall within the spectrum reported with other GLP-1RA CVOTs: noninferiority vs. placebo for major CV events was seen with lixisenatide and exenatide extended-release, while superiority was demonstrated with liraglutide, albiglutide, and dulaglutide...The exact mechanism(s) remains to be characterized, but appears to be mainly linked to anti-atherosclerotic effects. Further research is needed to elucidate the relevant mechanisms for CV benefits of GLP-1RAs.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Clinical, Review, Journal: Efficacy of Semaglutide in a Subcutaneous and an Oral Formulation. (Pubmed Central) - Jan 8, 2022
Across the PIONEER program, once-daily oral semaglutide 14 mg reduced HbA by 1.0-1.4%, significantly more than sitagliptin or empagliflozin, and to a similar extent as liraglutide after 26 weeks...Semaglutide offers the benefits of a highly effective GLP-1RA in both injectable and oral formulations. Selection of the most appropriate formulation can be made on an individual basis to best suit the patient's preferences and needs.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Clinical, Review, Journal: Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide. (Pubmed Central) - Jan 8, 2022
The evidence base surrounding the clinical use of semaglutide is being further expanded with trials investigating effects on diabetic retinopathy, cardiovascular outcomes, and on the common T2D comorbidities of obesity, chronic kidney disease, and non-alcoholic steatohepatitis. These will provide further information about whether the benefits of semaglutide extend to these other indications.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Clinical, Review, Journal: Safety of Semaglutide. (Pubmed Central) - Jan 8, 2022
Due to its potent glucose-lowering effect, patients at risk for deterioration of existing DRP should be carefully monitored if treated with semaglutide, particularly if also treated with insulin. Given the beneficial metabolic and cardiovascular actions of semaglutide, and the low risk for severe adverse events, semaglutide has an overall favorable risk/benefit profile for patient with type 2 diabetes.
- |||||||||| Clinical, Journal: Use of Glucagon-Like Peptide-1 Receptor Agonists in Patients With Type 2 Diabetes and Cardiovascular Disease: A Review. (Pubmed Central) - Jan 6, 2022
Most recently approved for clinical use, oral semaglutide has a favorable safety profile and is currently undergoing regulatory evaluation and further study for cardiovascular outcomes...Findings from this review suggest that GLP-1RAs are safe, are well tolerated, and improve cardiovascular outcomes, largely independent of their antihyperglycemic properties, but they remain underused by cardiologists. This review provides a practical resource for cardiologists for initiating GLP-1RAs and managing the therapy in patients with type 2 diabetes and established ASCVD or high risk for ASCVD.
- |||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: Glucagon-like peptide-1 receptor agonists in type 2 diabetes and long-term complications: FOCUS on retinopathy. (Pubmed Central) - Jan 1, 2022
This response was shown mainly in people with established cardiovascular disease, except for the REWIND trial, in which a majority of people without prior cardiovascular disease was included (69%). In those trials, in addition to the macrovascular benefits, GLP-1RAs also reduced some microvascular events; there was a reduction in a composite kidney outcome including macroalbuminuria [hazard ratio 0.83 (95% CI 0.78-0.89)] [1].
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Trial completion date: A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE) (clinicaltrials.gov) - Dec 27, 2021
P3, N=1840, Recruiting,
In those trials, in addition to the macrovascular benefits, GLP-1RAs also reduced some microvascular events; there was a reduction in a composite kidney outcome including macroalbuminuria [hazard ratio 0.83 (95% CI 0.78-0.89)] [1]. Trial completion date: Sep 2025 --> Apr 2026
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Clinical, Journal: Introducing a novel therapy for type 2 diabetes to primary care. (Pubmed Central) - Dec 25, 2021
Not yet recruiting --> Recruiting | Trial completion date: Mar 2023 --> Jan 2024 | Trial primary completion date: Feb 2023 --> Nov 2023 No abstract available
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Journal: Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®) (Pubmed Central) - Dec 21, 2021
Available in three doses (3, 7 and 14 mg) to be gradually increased, Rybelsus® is currently reimbursed in Belgium after failure of antidiabetic treatment (including metformin; HbA1C superior to 7.5 % or 58 mmol/mol) in T2DM patients with a body mass index ? 30 kg/m².
- |||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Retrospective data, Review, Journal, Adverse events: Association of Glucagon-like Peptide 1 Analogs and Agonists Administered for Obesity with Weight Loss and Adverse Events: A Systematic Review and Network Meta-analysis. (Pubmed Central) - Dec 10, 2021
Oral semaglutide appears efficacious and well tolerated in Japanese patients across the T2D spectrum. Direct meta-analysis showed significant WLOP with: -1.44kg (95% CI, -2.14 to -0.74) with dulaglutide ≥1.5 mg; -1.82kg (-2.42 to -1.23) with exenatide immediate release (IR); -2.20kg (-4.31 to -0.08) with exenatide extended release (ER); -3.20kg (-6.53 to 0.15) with efpeglenatide; -2.72kg (-3.35 to -2.09) with liraglutide ≤1.8mg; -4.49kg (-5.26 to -3.72) with liraglutide >1.8mg; -0.62kg (-1.22 to -0.02) with lixisenatide; -4.33kg (-5.71 to -3.00) with semaglutide SQ 50%) in WL and AEs reflected magnitude, not direction of effect.
- |||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. (Pubmed Central) - Nov 21, 2021
At present, GLP-1 RAs are injected twice daily (exenatide b.i.d.), once daily (lixisenatide and liraglutide), or once weekly (exenatide once weekly, dulaglutide, albiglutide, and semaglutide)...Novel indications for GLP-1 RAs outside type 2 diabetes, like type 1 diabetes, neuro-degenerative diseases, and psoriasis, are being explored. Thus, within 15 years of their initial introduction, GLP-1 RAs have become a well-established class of glucose-lowering agents which has the potential for further development and growing impact for the treatment of type 2 diabetes and potentially other diseases.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Clinical, Review, Journal: A Pharmacological and Clinical Overview of Oral Semaglutide for the Treatment of Type 2 Diabetes. (Pubmed Central) - Nov 21, 2021
Cardiovascular (CV) safety was shown to be noninferior to placebo and observations suggest that the CV profile of oral semaglutide is likely to be similar to that of subcutaneous semaglutide. The evolution of the GLP-1RA class to include an oral agent could facilitate the use of these agents earlier in the diabetes treatment cascade owing to wider acceptance from patients and healthcare professionals.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment closed, Trial completion date: Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People (clinicaltrials.gov) - Nov 4, 2021
P1, N=290, Active, not recruiting,
Trial completion date: Jul 2022 --> Jan 2023 | Trial primary completion date: Jul 2022 --> Jan 2023 Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Mar 2022
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Rybelsus (semaglutide oral) / Novo Nordisk
Journal: Obesity and GLP-1. (Pubmed Central) - Oct 30, 2021
Liraglutide in a dose of 3 mg is currently the only drug of this group that is approved by the FDA to treat obesity, with weight losses up to 8.5 kg in relatively short periods of time. Here we review the data so far collected of GLP-1 use for obesity with and without diabetes, including the recent data of oral semaglutide.
- |||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Journal: Efficacy and Cardiovascular Safety of GLP-1 Receptor Analogues. (Pubmed Central) - Oct 27, 2021
In this review, we discuss the available evidence from randomized controlled trials (RCTs) analyzing the cardiovascular effects of various GLP-1 RAs with the aim of comparing individual drugs. We have also summarized the general aspects of GLP-1RAs that can be applied in clinical practice.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Clinical, Review, Journal: A Review on the Efficacy and Safety of Oral Semaglutide. (Pubmed Central) - Oct 27, 2021
In the PIONEER trials, oral semaglutide effectively lowered blood glucose levels, and showed benefits on weight and cardiovascular outcomes; however, there is no Food and Drug Administration indication approved yet as the SOUL trial is still ongoing. Such characteristics of oral semaglutide may improve and increase its use compared to subcutaneous agents and possibly lead to earlier cardiovascular protection in addition to achieving glycemic control.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk
Retrospective data, Journal: Efficacy and Safety of Subcutaneous and Oral Semaglutide Administration in Patients With Type 2 Diabetes: A Meta-Analysis. (Pubmed Central) - Oct 27, 2021
Overall, we noted no clear evidence of detrimental effects on safety endpoints due to semaglutide treatment, except for some gastrointestinal adverse events. Both subcutaneous and oral semaglutide administration could enable the achievement of sufficient glycemic control and weight management without increasing the risk of hypoglycemia, which were effective and safe for the treatment of T2D.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Mycapssa (octreotide) / Amryt
Journal: Transient Permeation Enhancer® (TPE®) technology for oral delivery of octreotide: a technological evaluation. (Pubmed Central) - Oct 27, 2021
We evaluated the oral octreotide formulation, MYCAPSSA® (Chiasma Pharmaceuticals, Needham, MA, USA)...The oral octreotide dose required to achieve these endpoints was over 200 times that of the 0.1 mg immediate-release subcutaneous injection, a reminder of the difficulty in achieving oral absorption of macromolecules. Many acromegaly patients will prefer a convenient twice-daily oral formulation of octreotide compared to monthly depot injections.
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