Semaglutide tablets open a new journey for oral GLP-1RA

Editor’s note:2022 Annual Meeting of Endocrinologists and Metabolists of Chinese Medical Doctor Association Held in Guangzhou. This GLP-1 New Progress Session is chaired by Professor Zhou Zhiguang from the Second Xiangya Hospital of Central South University and Professor Xue Yaoming from the Southern Hospital, Professor Yan Li from Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Professor Li Xia from the Second Xiangya Hospital of Central South University, and the First Affiliated Hospital of Sun Yat-sen University Prof. Li Yanbing and Prof. Mu Yiming from the General Hospital of the Chinese People’s Liberation Army have respectively made “A Perfect Match – SNAC Achieves the First Oral GLP-1RA”, “Same Destination – Oral GLP-1RA Safety Data Secret”, “Breaking a Cocoon into a Butterfly – Oral GLP-1RA” Efficacy Data Demystified” and “My Peace of Mind – Cardiovascular Safety of Oral GLP-1RA”. The meeting mainly introduced the research and development of oral dosage forms of semaglutide and the exploration of suitable dosages. At the same time, the safety, efficacy and cardiovascular safety of semaglutide tablets were discussed in depth.

Professor Xue Yaoming span>Professor Zhou Zhiguang

>Mixed SNAC with Semaglutide

a good match for security

Professor Li Xia then focused on the overall safety of semaglutide tablets and the safety and efficacy in some special populations. In corresponding different clinical trials, the exposure of semaglutide tablets was not affected by patients with different degrees of liver function impairment and renal function impairment, and it did not cause the accumulation of SNAC. The presence of upper gastrointestinal disease and the combined use of acid-suppressing drugs did not affect the exposure of semaglutide tablets. There is no significant clinical impact when combined with commonly used drugs such as hypoglycemic, lipid-lowering, oral contraceptives. The role of semaglutide tablets in clinical trials in patients with moderate renal insufficiency has also been proven safe and effective. In the PIONEER series of studies evaluating the evidence of safety of semaglutide, nausea was the most common adverse reaction of semaglutide, but decreased over time. Semaglutide does not increase the incidence of gallbladder-related diseases, pancreatitis, diabetic retinopathy and related complications, and the incidence of severe or confirmatory hypoglycemia is low in the absence of sulfonylureas or insulin.

>High-quality combination for reducing sugar and weight

Next, Professor Li Yanbing further demonstrated the efficacy data of semaglutide tablets. Prof. Li analyzed the data of European and American populations in the PIONEER 1-5, 7-8 series of studies, and found that compared with several mainstream hypoglycemic drugs, semaglutide tablets reduced HbA1cA larger range, HbA1c compliance rate and composite compliance rate (composite compliance rate refers to: HbA1c< /span><7.0%, no weight gain, no severe or confirmatory hypoglycemia) were higher. The average fasting blood glucose and 7-point self-measured blood glucose were significantly reduced, and the body weight, systolic blood pressure, and blood lipids were also improved. Regardless of whether it is semaglutide monotherapy, combined with insulinOr flexible dose adjustment also has the above advantages. In the PIONEER 9, 10 (Japanese population) study, compared with liraglutide and dulaglutide, semaglutide tablets also achieved better hypoglycemic and weight loss effects, and the incidence of adverse events was significantly related to dulaglutide. resemblance. The PIONEER 11 and 12 trials will further confirm the efficacy and safety of semaglutide tablets in the clinical application of the Chinese population, which is worthy of our expectation.

“safe” oral GLP-1RA

Professor Yoshiaki Ma mainly introduced the research overview of PIONEER 6, the premarket cardiovascular outcome trial (CVOT) of semaglutide tablets. This is a randomized, double-blind, placebo-controlled trial of patients with type 2 diabetes at high risk of cardiovascular disease treated with semaglutide or placebo in addition to standard care. The results showed that semaglutide tablets did not increase the risk of MACE in patients and had good cardiovascular safety. This experiment also supports that semaglutide tablets have good hypoglycemic and weight loss effects, and the safety results are consistent with other PIONEER clinical trials. Next, Prof. Yoshiaki Ma summarized and analyzed the PIONEER 6 and SUSTAIN 6 trials (the CVOT trial of weekly semaglutide preparations) with similar research trial designs. These two cardiovascular outcome trials together confirmed that semaglutide molecules can carry cardiovascular benefit. Finally, Professor Mu introduced that the SOUL study will further explore the cardiovascular benefits of semaglutide tablets.

>Possible future for oral GLP-1RA

From this meeting, participants The authors clearly understand that while semaglutide tablets provide oral convenience, they retain the advantages of semaglutide weekly preparations for hypoglycemic and weight loss, and the addition of SNAC does not affect the Its application in some special patients with impaired liver and kidney function, its overall safety has also been fully affirmed in clinical phase 2 and 3 trials, and it has cardiovascular safety. It is believed that its various advantages will promote the acceptance of semaglutide tablets in more regions and countries, bringing good news to the majority of patients with type 2 diabetes.

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(Source: International Diabetes Editor)

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