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24 Trials |  |
921 News |  |
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- Rybelsus (semaglutide oral) / Novo Nordisk, Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, Januvia (sitagliptin) / Merck (MSD)
EFFICACY OF ORAL SEMAGLUTIDE ACCORDING TO BASELINE HBA1C: AN EXPLORATORY SUBGROUP ANALYSIS OF THE PIONEER TRIAL PROGRAMME (Station 4 (E-Poster Area)) - Dec 29, 2019 - Abstract #ATTD2020ATTD_811;
Conclusions Oral semaglutide showed improved glycaemic control across baseline HbA1c subgroups in the PIONEER trials, with greater reductions in HbA1c with oral semaglutide 7 and 14 mg versus all comparators in all subgroups. Reductions in HbA1c were greater with higher oral semaglutide dose and higher baseline HbA1c.
- Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
SIMILAR EFFICACY AND GASTROINTESTINAL TOLERABILITY VERSUS EXPOSURE FOR ORAL AND SUBCUTANEOUS SEMAGLUTIDE (E-Poster Area) - Dec 29, 2019 - Abstract #ATTD2020ATTD_605;
Methods Population pharmacokinetic data were compared from four 30-week trials (SUSTAIN 1–3, SUSTAIN-Japan) of once-weekly s.c. semaglutide (0.5, 1.0 mg; N=1552) and six 26-week trials (PIONEER 1–3, 5, 8, 9) of once-daily oral semaglutide (3, 7, 14 mg; N=3003)...Exposure–response relationships were consistent across the SUSTAIN and PIONEER datasets, and even more consistent when using propensity-matched data. Conclusions Exposure–response relationships for oral and s.c. semaglutide efficacy and tolerability were similar; the greater variability in semaglutide plasma concentrations following oral administration does not impact response.
- Rybelsus (semaglutide oral) / Novo Nordisk, Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, Januvia (sitagliptin) / Merck (MSD)
EFFICACY OF ORAL SEMAGLUTIDE ACCORDING TO DIABETES DURATION: AN EXPLORATORY SUBGROUP ANALYSIS OF THE PIONEER TRIAL PROGRAMME (E-Poster Area) - Dec 29, 2019 - Abstract #ATTD2020ATTD_594;
Conclusions Across the PIONEER trials, oral semaglutide improved glycaemic control versus comparators, with an effect that was consistent across subgroups of diabetes duration. These findings support the use of oral semaglutide across a broad population of patients with type 2 diabetes.
- | Rybelsus (semaglutide oral) / Novo Nordisk, metformin / Generic mfg., Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Review, Journal: Oral semaglutide (Rybelsus) for type 2 diabetes. (Pubmed Central) - Dec 22, 2019
These findings support the use of oral semaglutide across a broad population of patients with type 2 diabetes. No abstract available
- | Review, Journal: Drugs for type 2 diabetes. (Pubmed Central) - Dec 22, 2019
No abstract available No abstract available
- Ozempic (semaglutide SC once-weekly) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
[VIRTUAL] EFFECTS OF SEMAGLUTIDE VERSUS COMPARATORS ON CARDIOVASCULAR EVENTS ACROSS A CONTINUUM OF BASELINE CARDIOVASCULAR RISK: COMBINED ANALYSIS OF THE SUSTAIN AND PIONEER TRIALS (eAbstract Virtual Hall) - Dec 22, 2019 - Abstract #ACC2020ACC_6919;
Background: In patients with type 2 diabetes (T2D) at high risk of CV events, there were fewer major adverse CV events (MACE) with semaglutide vs placebo (HRs [95% CIs]: 0.74 [0.58;0.95] for subcutaneous, 0.79 [0.57;1.11] for oral semaglutide)... Semaglutide reduced the risk of MACE vs comparators in patients with T2D across baseline CV risk, including low CV risk.
- |||| Rybelsus (semaglutide oral) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical: Not surprisingly, considerable attention here devoted to oral #semaglutide the SNAC magic, mechanisms, and the PIONEER clinical development program #Diabetes #CVD (Twitter) - Dec 17, 2019
- || Clinical, Journal, HEOR: Oral Semaglutide Versus Empagliflozin, Sitagliptin and Liraglutide in the UK: Long-Term Cost-Effectiveness Analyses Based on the PIONEER Clinical Trial Programme. (Pubmed Central) - Dec 15, 2019
Semaglutide reduced the risk of MACE vs comparators in patients with T2D across baseline CV risk, including low CV risk. Oral semaglutide was cost-effective versus empagliflozin and sitagliptin, and dominant versus liraglutide, for the treatment of type 2 diabetes in the UK.
- || Rybelsus (semaglutide oral) / Novo Nordisk
Review, Journal: Oral Semaglutide In The Management Of Type 2 Diabetes: A Report On The Evidence To Date. (Pubmed Central) - Dec 12, 2019
More recently, a GLP-1 agonist has been developed, semaglutide, that can be administered orally which has at least similar effects to the subcutaneous preparation from which this compound is derived. In this review article, we discuss the glycemic and cardiovascular effects of the GLP-1 agonists with special emphasis on oral semaglutide and the potential role of this therapy in individuals with type 2 diabetes.
- | Rybelsus (semaglutide oral) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Semaglutide "formulation C" 11.2 mg vs Rybelsus 14 mg. The new formulation provides only 25% increase in absorption?? C'mon @novonordisk! you can do much better!! #rybelsus #novonordisk #oral #peptides #drugdelivery (Twitter) - Dec 11, 2019
- || Rybelsus (semaglutide oral) / Novo Nordisk, Januvia (sitagliptin) / Merck (MSD)
Head-to-Head: ICER committee sees benefit in oral semaglutide, but superiority over sitagliptin not demonstrated https://t.co/yNtspEMjCo @icer_review @novonordisk #pharma (Twitter) - Dec 10, 2019
- || Rybelsus (semaglutide oral) / Novo Nordisk
💯 particularly with oral semaglutide on the the horizon. (Twitter) - Nov 28, 2019
- | Rybelsus (semaglutide oral) / Novo Nordisk
Journal: Oral Semaglutide and Cardiovascular Outcomes in Type 2 Diabetes. (Pubmed Central) - Nov 25, 2019
In this review article, we discuss the glycemic and cardiovascular effects of the GLP-1 agonists with special emphasis on oral semaglutide and the potential role of this therapy in individuals with type 2 diabetes. No abstract available
- | Rybelsus (semaglutide oral) / Novo Nordisk
Journal: Oral Semaglutide and Cardiovascular Outcomes in Type 2 Diabetes. Reply. (Pubmed Central) - Nov 25, 2019
No abstract available No abstract available
- | Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Novo preps for Rybelsus 'strike mode' as Ozempic hits blockbuster heights @FiercePharma https://t.co/rllhpu6TFV (Twitter) - Nov 4, 2019
- | Rybelsus (semaglutide oral) / Novo Nordisk
Clinical, PK/PD data, Journal: Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment. (Pubmed Central) - Nov 2, 2019
P1
There was no apparent effect of renal impairment or haemodialysis on the pharmacokinetics of oral semaglutide. Based on this trial, renal impairment should not affect dose recommendations for oral semaglutide.
- | Rybelsus (semaglutide oral) / Novo Nordisk
Clinical, PK/PD data, Journal: Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. (Pubmed Central) - Oct 12, 2019
P1
There was no apparent effect of hepatic impairment on the pharmacokinetics, safety, and tolerability of oral semaglutide. The results of this trial suggest that dose adjustment of oral semaglutide is not warranted in subjects with hepatic impairment.
- | Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets (clinicaltrials.gov) - Oct 11, 2019
P1, N=240, Recruiting, Sponsor: Novo Nordisk A/S
The results of this trial suggest that dose adjustment of oral semaglutide is not warranted in subjects with hepatic impairment. Not yet recruiting --> Recruiting
- | Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese (clinicaltrials.gov) - Oct 9, 2019
P1, N=32, Recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: PIONEER 11: A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes (clinicaltrials.gov) - Oct 2, 2019
P3, N=664, Recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets (clinicaltrials.gov) - Oct 2, 2019
P1, N=240, Recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Rybelsus (semaglutide oral) / Novo Nordisk
New P3 trial: PIONEER 11: A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes (clinicaltrials.gov) - Sep 29, 2019
P3, N=664, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Rybelsus (semaglutide oral) / Novo Nordisk
New P1 trial: A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets (clinicaltrials.gov) - Sep 29, 2019
P1, N=240, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Rybelsus (semaglutide oral) / Novo Nordisk
Trial completion date, Trial primary completion date: TEAL: Treating PCOS With Semaglutide vs Active Lifestyle Intervention (clinicaltrials.gov) - Sep 25, 2019
P2/3, N=50, Not yet recruiting, Sponsor: University of Colorado, Denver
Not yet recruiting --> Recruiting Trial completion date: Jul 2025 --> Jul 2024 | Trial primary completion date: Oct 2024 --> Jul 2024
- ||| Rybelsus (semaglutide oral) / Novo Nordisk
An update on oral semaglutide. #T2DM https://t.co/QBo5vM41iX #EASD2019 (Twitter) - Sep 25, 2019
- || Rybelsus (semaglutide oral) / Novo Nordisk
DocTalk Podcast: Approval of Oral Semaglutide and PIONEER with Dr. Aroda https://t.co/w9pqnba1VI via @mdmagazine @ArodaMd #greatjob (Twitter) - Sep 24, 2019
- | Rybelsus (semaglutide oral) / Novo Nordisk
@novonordiskus $nvo #OralSemaglutide (Twitter) - Sep 23, 2019
- |||| Rybelsus (semaglutide oral) / Novo Nordisk
Clinical: The PIONEER 4 trial showed that oral semaglutide is noninferior to injectable liraglutide and superior to placebo in improving glycemic control and weight loss at 26 weeks among patients with type 2 #diabetes. Read more: https://t.co/LSnVNo8rTU @DLBHATTMD (Twitter) - Sep 23, 2019
- |||| semaglutide oral (NN9924) / Novo Nordisk
FDA event: FDA approves oral semaglutide @kamleshkhunti (Twitter) - Sep 20, 2019
- | Rybelsus (semaglutide oral) / Novo Nordisk
New P1 trial: A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets (clinicaltrials.gov) - Sep 19, 2019
P1, N=240, Not yet recruiting, Sponsor: Novo Nordisk A/S
- || semaglutide oral (NN9924) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Vandaag op de #EASD2019. Het #PIONEER studieprogramma met orale semaglutide. Wij zetten alle publicaties op een rij; PIONEER 1 (https://t.co/HzhSeDnwQw), PIONEER 2 (https://t.co/HHGmaxBcrx), PIONEER 3 (https://t.co/wZjw2EVkaR), PIONEER 4 (https://t.co/sMUAVadLCQ) (1 van 2) (Twitter) - Sep 17, 2019
- |||| semaglutide oral (NN9924) / Novo Nordisk
Clinical: J Meier presenta un metanalisis de subgrupos de los estudios #PIONNER contra placebo contra comprador activo de eficacia en control glucémico y peso de semaglutide oral #EASD2019 (Twitter) - Sep 17, 2019
- |||| semaglutide oral (NN9924) / Novo Nordisk
Adverse events: Q. Does baseline of HbA1c impact on efficiency of Oral Semaglutide? A. Yes for HbA1c and No for weight or adverse effects. #EASD2019 (Twitter) - Sep 17, 2019
- ||| semaglutide oral (NN9924) / Novo Nordisk
Results according to baseline HbA1c for oral Semaglutide @EASDnews #easd19 (Twitter) - Sep 17, 2019
- ||| semaglutide oral (NN9924) / Novo Nordisk
Resultados del primer desenlace en PIONEER (Semaglutide oral). #EASD2019 (Twitter) - Sep 17, 2019
- || semaglutide oral (NN9924) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Attending the #EASD2019 session on the #PIONEER journey of #oral #semaglutide? Check out the main results of the PIONEER 4 (https://t.co/MSr2mluZut), 5 (https://t.co/XCVWuxkGo1), and 7 (https://t.co/Au4qv7R4Rx) trials in @TheLancetEndo & @TheLancet (Twitter) - Sep 17, 2019
- |||| semaglutide oral (NN9924) / Novo Nordisk
PDUFA date: The PDUFA date @US_FDA for oral Semaglutide is September 20-An overview of the PIONEER program #EASD2019 @EASDnews Tuesday 13:15 Ochoa Hall (Twitter) - Sep 17, 2019
- | semaglutide oral (NN9924) / Novo Nordisk
Clinical, Journal: Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. (Pubmed Central) - Sep 6, 2019
P3
In this trial involving patients with type 2 diabetes, the cardiovascular risk profile of oral semaglutide was not inferior to that of placebo. (Funded by Novo Nordisk; PIONEER 6 ClinicalTrials.gov number, NCT02692716.).
- |||| semaglutide oral (NN9924) / Novo Nordisk
Clinical: Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes | NEJM https://t.co/jCeaoBYXLw (Twitter) - Aug 28, 2019
- |||| semaglutide oral (NN9924) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Kudos to @johnbu08 for leading our efforts on this terrific review of oral #semaglutide 👇https://t.co/OobJJQYz95 @EMSisson @accpambuprn @accpendoprn @accpcardprn @totocarbone @mikesbkelly #diabetes (Twitter) - Aug 23, 2019
- | semaglutide oral (NN9924) / Novo Nordisk
Slight correction: $NVO tells us it used a separate (undisclosed) #PRV for oral semaglutide. The one it bought from Medicines Development is still in play (Twitter) - Aug 23, 2019
- | semaglutide oral (NN9924) / Novo Nordisk, Januvia (sitagliptin) / Merck (MSD)
Clinical, Journal: Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. (Pubmed Central) - Aug 17, 2019
P3
Further research is needed to assess effectiveness in a clinical setting. ClinicalTrials.gov Identifier: NCT02607865.
- | Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: PIONEER 12: A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes (clinicaltrials.gov) - Jul 30, 2019
P3, N=1444, Recruiting, Sponsor: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02607865. Not yet recruiting --> Recruiting
- | semaglutide oral (NN9924) / Novo Nordisk
Clinical, P3 data, Journal: Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. (Pubmed Central) - Jul 21, 2019
P3
Safety and tolerability of oral semaglutide were similar to subcutaneous liraglutide. Use of oral semaglutide could potentially lead to earlier initiation of GLP-1 receptor agonist therapy in the diabetes treatment continuum of care.
- | Rybelsus (semaglutide oral) / Novo Nordisk
New P3 trial: PIONEER 12: A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes (clinicaltrials.gov) - Jul 11, 2019
P3, N=1444, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | Rybelsus (semaglutide oral) / Novo Nordisk
New P1 trial: A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese (clinicaltrials.gov) - Jul 11, 2019
P1, N=32, Not yet recruiting, Sponsor: Novo Nordisk A/S
- |||||| Rybelsus (semaglutide oral) / Novo Nordisk
Enrollment open: SOUL: A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (clinicaltrials.gov) - Jun 18, 2019
P3, N=9642, Recruiting, Sponsor: Novo Nordisk A/S
Use of oral semaglutide could potentially lead to earlier initiation of GLP-1 receptor agonist therapy in the diabetes treatment continuum of care. Not yet recruiting --> Recruiting
- || semaglutide oral (NN9924) / Novo Nordisk, semaglutide SC once-daily (NN9536) / Novo Nordisk
Important insight re oral #semaglutide from #ADA2019 @ABCDiab (Twitter) - Jun 12, 2019
- ||||| semaglutide oral (NN9924) / Novo Nordisk
Clinical: Oral Semaglutide cardiovascular risk profile was non-inferior to placebo. This is the first oral glucagon-like peptide-1 receptor agonist. In the future, an option for Patients with Type 2 Diabetes @NEJM https://t.co/jT15u90BuH (Twitter) - Jun 11, 2019
- ||| semaglutide oral (NN9924) / Novo Nordisk
Resumen hipoglucemias semaglutide oral en #PIONEER6 #ADA2019 (Twitter) - Jun 11, 2019