Oral semaglutide proves superior to empagliflozin, noninferior to liraglutide for lowering HbA1c

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SAN FRANCISCO — Favorable outcomes from two PIONEER trials of an oral model of the GLP-1 receptor agonist semaglutide had been introduced on the American Diabetes Affiliation Scientific Periods.

Richard E. Pratley

In PIONEER 2, oral semaglutide (Novo Nordisk) was related to superior HbA1c reductions vs. the oral SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim) in addition to important weight reduction at 52 weeks.

In PIONEER 4, the agent was proven to be noninferior to the injectable GLP-1 receptor agonist liraglutide (Victoza, Novo Nordisk) and superior to placebo when it comes to HbA1c reductions, and in addition superior to each liraglutide and placebo when it comes to weight reduction.

“Oral semaglutide … is the primary GLP-1 receptor agonist that has entered into part Three improvement. It’s a pill formation and has the potential to grow to be a brand new remedy for kind 2 diabetes,” Richard E. Pratley, MD, the Samuel E. Crockett chair in diabetes analysis and medical director of AdventHealth Diabetes Institute, stated throughout his presentation. “However what we’d actually love to do is see the way it stacks up in opposition to different drugs in head-to-head research, like SGLT2 inhibitors and, importantly, GLP-1 receptor agonists.”

As Endocrine Right now beforehand reported, oral semaglutide confirmed superior HbA1c reductions vs. the oral DPP-IV inhibitor sitagliptin (Januvia, Merck) within the PIONEER Three trial.

Every of the research introduced in contrast efficacy and security of 14 mg every day oral semaglutide with one other agent for adults with kind 2 diabetes uncontrolled with metformin. Primarily based on discussions with regulatory companies, every examine employed two estimands: the remedy coverage estimand, which assessed outcomes in all individuals no matter discontinuation or use of different diabetes drugs, and the trial product estimand, which assessed outcomes solely in individuals who continued within the trial and didn’t use rescue drugs.

Semaglutide vs. SGLT2 inhibitor

Eduard Montanya

Within the 52-week, open-label trial PIONEER 2, researchers randomly assigned individuals to 14 mg every day semaglutide (n = 411; 50% males; imply age, 57 years; imply diabetes period, 7.2 years; imply HbA1c, 8.1%; imply physique weight, 91.9 kg) or 25 mg empagliflozin every day (n = 410; 51% males; imply age, 58 years; imply diabetes period, 7.7 years; imply HbA1c, 8.1%; imply physique weight, 91.Three kg), in keeping with presenter Eduard Montanya, MD, PhD, professor within the division of medical sciences on the College of Barcelona.

Among the many semaglutide group, 97.1% accomplished the trial, as did 94.4% of the empagliflozin group, and charges of those that accomplished the trial on the examine drugs had been related for the 2 teams: 78.5% for the semaglutide group and 82.3% for the empagliflozin group.

At week 26, HbA1c was lowered extra from baseline with semaglutide (remedy coverage imply discount, –1.3%; trial product imply discount, –0.9%; P .0001) than with empagliflozin (remedy coverage imply discount, –1.4%; trial product imply discount, –0.9%) for superiority of semaglutide over empagliflozin. Related outcomes had been seen at week 52.

The proportion of individuals who achieved an HbA1c of lower than 7% was larger with semaglutide (remedy coverage, 66.8%; trial product, 70.3%) than with empagliflozin (remedy coverage, 40%; trial product, 40.7%) at 26 weeks and equally at 52 weeks (P .0001 for all).

At week 52, however not at week 26, semaglutide was proven to be much like empagliflozin when it comes to physique weight discount, in keeping with Montanya. At week 52, based mostly on the trial product estimand, the semaglutide group had misplaced a imply –4.7 kg vs. –3.Eight kg with empagliflozin (P .05).

Adversarial occasions, largely associated to nausea, diarrhea and vomiting, had been related in each teams. Nausea diminished over time and was reported by 20% of the semaglutide group and a pair of% of the empagliflozin group; 11% of the semaglutide group discontinued attributable to opposed occasions vs. 4% for of the empagliflozin group. Hypoglycemic occasion charges had been low in each teams, in keeping with Montanya.

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Favorable outcomes from two PIONEER trials of an oral model of the GLP-1 receptor agonist semaglutide had been introduced on the American Diabetes Affiliation Scientific Periods.

Adobe Inventory

“At week 26, oral semaglutide was superior to empagliflozin for decreasing HbA1c. Superiority for physique weight discount was not confirmed, however at week 52 oral semaglutide considerably lowered HbA1c and in addition lowered physique weight when analyzed based mostly on the trial product estimand vs. empagliflozin,” Montanya stated. “Within the security evaluation, semaglutide was well-tolerated, and the security was discovered much like what has been seen for different GLP-1 receptor agonists.”

Semaglutide vs. GLP-1 injection

Within the 52-week, randomized, double-blind trial PIONEER 4, researchers assigned 285 adults to semaglutide, 284 adults to 1.Eight mg liraglutide per day and 142 adults to placebo. Teams had been considerably related with 48% ladies, 73% white, imply age of 56 years, imply HbA1c of 8%, imply diabetes period of seven.6 years, 26% prescribed an SGLT2 inhibitor, and imply BMI of 33 kg/m2.

At 26 weeks, related reductions in HbA1c had been noticed within the semaglutide group vs. the liraglutide group for noninferiority of semaglutide to liraglutide. Semaglutide was superior in decreasing HbA1c to placebo. At 52 weeks, reductions in HbA1c had been considerably larger for the semaglutide group (each estimands imply discount, –1.2%) vs. the liraglutide group (each estimands imply discount, –0.9%; P .01) and the placebo group (each estimands imply discount, –0.2%; P .0001) .

The proportion of individuals who achieved an HbA1c of lower than 7% or lower than 6.5% had been related for the semaglutide and liraglutide teams at 26 weeks; at 52 weeks, the semaglutide individuals had been considerably extra possible than the liraglutide individuals to attain an HbA1c of lower than 6.5% based mostly on each estimands, in keeping with information concurrently printed in The Lancet.

At 26 weeks, weight lack of at the least 5% was noticed amongst extra of the semaglutide group (remedy coverage, 43.5%; trial product, 46.2%) vs. the liraglutide (remedy coverage, 27.7%; trial product, 28.3%; P .01) and placebo teams (remedy coverage, 7.5%; trial product, 7.1%; P .0001). Weight-loss outcomes had been maintained at 52 weeks, in keeping with Pratley, for superiority of semaglutide to liraglutide.

Adversarial occasions — largely gastrointestinal and nausea, specifically —had been extra frequent with semaglutide (80% of individuals) than with liraglutide (74%) or placebo (67%) however had been per the GLP-1 receptor agonist class normally, in keeping with Pratley.

“My view is that as many sufferers and, certainly, suppliers are reluctant to accentuate or provoke remedy with an injectable, oral semaglutide could also be a really efficient remedy choice to permit earlier use of GLP-1 receptor agonists,” Pratley stated. – by Jill Rollet

References:

Montanya E, et al. 54-OR.

Pratley RE, et al. 55-OR. Each introduced at: American Diabetes Affiliation 79th Scientific Periods; June 7-11, 2019; San Francisco.

Pratley R, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31271-1.

Disclosures: Montanya studies he serves on advisory panels for AstraZeneca, Novo Nordisk and Servier; is a marketing consultant to Merck and Novartis Prescribed drugs; receives analysis assist from Menarini Group; and is on the audio system bureau for Novo Nordisk. Pratley studies he’s a marketing consultant to Sanofi US and has different related monetary relationships with AstraZeneca, Eli Lilly, GlaxoSmithKline, Janssen, Lexicon Prescribed drugs, Ligand Prescribed drugs, Merck, Mundipharma, Novo Nordisk, Pfizer, Sanofi and Takeda Improvement Middle Americas.

SAN FRANCISCO — Favorable outcomes from two PIONEER trials of an oral model of the GLP-1 receptor agonist semaglutide had been introduced on the American Diabetes Affiliation Scientific Periods.

Richard E. Pratley

In PIONEER 2, oral semaglutide (Novo Nordisk) was related to superior HbA1c reductions vs. the oral SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim) in addition to important weight reduction at 52 weeks.

In PIONEER 4, the agent was proven to be noninferior to the injectable GLP-1 receptor agonist liraglutide (Victoza, Novo Nordisk) and superior to placebo when it comes to HbA1c reductions, and in addition superior to each liraglutide and placebo when it comes to weight reduction.

“Oral semaglutide … is the primary GLP-1 receptor agonist that has entered into part Three improvement. It’s a pill formation and has the potential to grow to be a brand new remedy for kind 2 diabetes,” Richard E. Pratley, MD, the Samuel E. Crockett chair in diabetes analysis and medical director of AdventHealth Diabetes Institute, stated throughout his presentation. “However what we’d actually love to do is see the way it stacks up in opposition to different drugs in head-to-head research, like SGLT2 inhibitors and, importantly, GLP-1 receptor agonists.”

As Endocrine Right now beforehand reported, oral semaglutide confirmed superior HbA1c reductions vs. the oral DPP-IV inhibitor sitagliptin (Januvia, Merck) within the PIONEER Three trial.

Every of the research introduced in contrast efficacy and security of 14 mg every day oral semaglutide with one other agent for adults with kind 2 diabetes uncontrolled with metformin. Primarily based on discussions with regulatory companies, every examine employed two estimands: the remedy coverage estimand, which assessed outcomes in all individuals no matter discontinuation or use of different diabetes drugs, and the trial product estimand, which assessed outcomes solely in individuals who continued within the trial and didn’t use rescue drugs.

Semaglutide vs. SGLT2 inhibitor

Eduard Montanya

Within the 52-week, open-label trial PIONEER 2, researchers randomly assigned individuals to 14 mg every day semaglutide (n = 411; 50% males; imply age, 57 years; imply diabetes period, 7.2 years; imply HbA1c, 8.1%; imply physique weight, 91.9 kg) or 25 mg empagliflozin every day (n = 410; 51% males; imply age, 58 years; imply diabetes period, 7.7 years; imply HbA1c, 8.1%; imply physique weight, 91.Three kg), in keeping with presenter Eduard Montanya, MD, PhD, professor within the division of medical sciences on the College of Barcelona.

Among the many semaglutide group, 97.1% accomplished the trial, as did 94.4% of the empagliflozin group, and charges of those that accomplished the trial on the examine drugs had been related for the 2 teams: 78.5% for the semaglutide group and 82.3% for the empagliflozin group.

PAGE BREAK

At week 26, HbA1c was lowered extra from baseline with semaglutide (remedy coverage imply discount, –1.3%; trial product imply discount, –0.9%; P .0001) than with empagliflozin (remedy coverage imply discount, –1.4%; trial product imply discount, –0.9%) for superiority of semaglutide over empagliflozin. Related outcomes had been seen at week 52.

The proportion of individuals who achieved an HbA1c of lower than 7% was larger with semaglutide (remedy coverage, 66.8%; trial product, 70.3%) than with empagliflozin (remedy coverage, 40%; trial product, 40.7%) at 26 weeks and equally at 52 weeks (P .0001 for all).

At week 52, however not at week 26, semaglutide was proven to be much like empagliflozin when it comes to physique weight discount, in keeping with Montanya. At week 52, based mostly on the trial product estimand, the semaglutide group had misplaced a imply –4.7 kg vs. –3.Eight kg with empagliflozin (P .05).

Adversarial occasions, largely associated to nausea, diarrhea and vomiting, had been related in each teams. Nausea diminished over time and was reported by 20% of the semaglutide group and a pair of% of the empagliflozin group; 11% of the semaglutide group discontinued attributable to opposed occasions vs. 4% for of the empagliflozin group. Hypoglycemic occasion charges had been low in each teams, in keeping with Montanya.

#

Favorable outcomes from two PIONEER trials of an oral model of the GLP-1 receptor agonist semaglutide had been introduced on the American Diabetes Affiliation Scientific Periods.

Adobe Inventory

“At week 26, oral semaglutide was superior to empagliflozin for decreasing HbA1c. Superiority for physique weight discount was not confirmed, however at week 52 oral semaglutide considerably lowered HbA1c and in addition lowered physique weight when analyzed based mostly on the trial product estimand vs. empagliflozin,” Montanya stated. “Within the security evaluation, semaglutide was well-tolerated, and the security was discovered much like what has been seen for different GLP-1 receptor agonists.”

Semaglutide vs. GLP-1 injection

Within the 52-week, randomized, double-blind trial PIONEER 4, researchers assigned 285 adults to semaglutide, 284 adults to 1.Eight mg liraglutide per day and 142 adults to placebo. Teams had been considerably related with 48% ladies, 73% white, imply age of 56 years, imply HbA1c of 8%, imply diabetes period of seven.6 years, 26% prescribed an SGLT2 inhibitor, and imply BMI of 33 kg/m2.

At 26 weeks, related reductions in HbA1c had been noticed within the semaglutide group vs. the liraglutide group for noninferiority of semaglutide to liraglutide. Semaglutide was superior in decreasing HbA1c to placebo. At 52 weeks, reductions in HbA1c had been considerably larger for the semaglutide group (each estimands imply discount, –1.2%) vs. the liraglutide group (each estimands imply discount, –0.9%; P .01) and the placebo group (each estimands imply discount, –0.2%; P .0001) .

PAGE BREAK

The proportion of individuals who achieved an HbA1c of lower than 7% or lower than 6.5% had been related for the semaglutide and liraglutide teams at 26 weeks; at 52 weeks, the semaglutide individuals had been considerably extra possible than the liraglutide individuals to attain an HbA1c of lower than 6.5% based mostly on each estimands, in keeping with information concurrently printed in The Lancet.

At 26 weeks, weight lack of at the least 5% was noticed amongst extra of the semaglutide group (remedy coverage, 43.5%; trial product, 46.2%) vs. the liraglutide (remedy coverage, 27.7%; trial product, 28.3%; P .01) and placebo teams (remedy coverage, 7.5%; trial product, 7.1%; P .0001). Weight-loss outcomes had been maintained at 52 weeks, in keeping with Pratley, for superiority of semaglutide to liraglutide.

Adversarial occasions — largely gastrointestinal and nausea, specifically —had been extra frequent with semaglutide (80% of individuals) than with liraglutide (74%) or placebo (67%) however had been per the GLP-1 receptor agonist class normally, in keeping with Pratley.

“My view is that as many sufferers and, certainly, suppliers are reluctant to accentuate or provoke remedy with an injectable, oral semaglutide could also be a really efficient remedy choice to permit earlier use of GLP-1 receptor agonists,” Pratley stated. – by Jill Rollet

References:

Montanya E, et al. 54-OR.

Pratley RE, et al. 55-OR. Each introduced at: American Diabetes Affiliation 79th Scientific Periods; June 7-11, 2019; San Francisco.

Pratley R, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31271-1.

Disclosures: Montanya studies he serves on advisory panels for AstraZeneca, Novo Nordisk and Servier; is a marketing consultant to Merck and Novartis Prescribed drugs; receives analysis assist from Menarini Group; and is on the audio system bureau for Novo Nordisk. Pratley studies he’s a marketing consultant to Sanofi US and has different related monetary relationships with AstraZeneca, Eli Lilly, GlaxoSmithKline, Janssen, Lexicon Prescribed drugs, Ligand Prescribed drugs, Merck, Mundipharma, Novo Nordisk, Pfizer, Sanofi and Takeda Improvement Middle Americas.

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