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DIABETES

“Insulin patches” and “oral insulin” summarize nine news reports in the field of diabetes treatment

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Guide: Recently, the Endocrine today website has compiled nine major news reports in the field of diabetes, including “insulin patches”, “oral insulin”, “new drug marketing applications” and other content that everyone may be interested in, Xiaobian carried outOrganize and share with teachers.1 Studies have confirmed that “Insulin patch” is an effective insulin for T2DM patients, which is the best choice for reducing blood sugar in some diabetic patients, but its conventional injection method will bring additional burden on patients in some aspects (Such as fear of injections, social pressure, interference from daily life, decline in quality of life, etc.).An “insulin patch” is actually a small, wearable meal pump for insulin injections (see Figure 1).Researchers evaluated the difference in effectiveness and safety from conventional insulin pens. This study included 278 patients with type 2 diabetes (T2DM) aged around 60 years, and participants were randomly assigned to routineIn the injection pen group and the insulin patch group, the researchers compared the effectiveness and safety of insulin patches with conventional insulin pens over a 48-week period.The results of the study showed that there were no significant differences in blood glucose control, adverse event (hypoglycemia), weight change, and insulin dosage between the two groups of participants.Also, research shows that insulin patches are significantly more popular than injection pens.2 The safety and effectiveness of “oral insulin” was confirmed by clinical IIb studies. A press release issued by the manufacturer on November 12, 2019 showed that oral insulin-ORMD-0801, was in a phase IIb involving 269 T2DM patients.Clinical studies have shown significant hypoglycemic efficacy and safety, and these drugs have the potential to become the first oral insulin in capsule form.This is a double-blind, placebo-controlled, randomized controlled trial. A total of 269 T2DM patients with poor glycemic control were included. These participants were randomized into the intervention group and the placebo control group. At 12 weeks, the intervention group had significantly higher blood glucose than the control group.There was a reduction of 0.54% (P = 0.036), and no serious drug-related adverse reactions were observed during the trial, and no significant increase in body weight was observed.However, it is not difficult to see from the test subjects that the target population of oral insulin is T2DM patients.3 The new drug application was rejected by the US FDA, low-dose englitazone should not be used for type 1 diabetes. The US FDA Endocrine and Metabolic Drug Information Committee rejected 14 low votes and 2 votes in favor of the manufacturer’s low-dose (2.5mg)Application as an oral hypoglycemic agent other than insulin as an adult T1DM patient.Investigating the reason, the members of the committee considered that the 2.5 mg dose of englitazone had lower glycemic benefits, and there was insufficient evidence to evaluate the diabetic ketoacidosis event.In short, there is currently insufficient data to support the efficacy and safety of this dose of englitazone in T1DM patients.4 For newly diagnosed T2DM, the initial choice of combined medication is more significant. At the Heart Metabolic Health Conference held in Chicago, USA in October 2019, Professor Rosenstock from the University of Texas Southwestern Medical Center believes that for newly diagnosed T2DM patients,Follow the current “Guide to monotherapy with metformin as the first choice, if the blood sugar is still not effectively controlled after a few months, consider combining other medications.”1RA or DPP-4i was used as the initial treatment regimen.Professor Rosenstock believes that these new hypoglycemic drugs have been proven by research to have multiple additional benefits, and it is meaningful to use metformin as an initial treatment plan.5 The first oral GLP-1 receptor agonist was approved by the US FDA for marketing. Compared with short-acting injectable hypoglycemic drugs, long-acting GLP-1RA only requires injection once a week, which reduces the patient’s medication pain.Improved medication compliance.However, the majority of diabetic patients are looking forward to the early emergence of oral dosage forms.Finally, on September 20, 2019, the U.S. FDA official website announced that the oral formulation (tablet) of somaglutide has been officially approved to aid dietary control and exercise to improve blood glucose control in adults with type 2 diabetes.It is also the first non-injectable glucagon-like peptide-1 receptor agonist to be used in the United States, which is undoubtedly good news for patients.At the same time, the FDA also shared with you some of the use of oral somaglutide. Note: This product should be used on an empty stomach, that is, at least 30 minutes before the first daily consumption of other drugs, and the amount of water should not exceed 4Ounces (about 113g).Because these drugs cause delayed gastric emptying, the doctor should communicate with the patient before use. If the patient is taking other drugs at the same time, the impact of delayed gastric emptying on drug absorption should be evaluated.At the same time, medical staff should remind patients that common side effects that may occur when using this medicine, such as nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.6 The US FDA rejects the application of soglitazone for the treatment of type 1 diabetes. Unlike SGLT-2i, such as daglitazone and englitazone, sotagliflozin is a sodium-glucose cotransporter.Double-acting inhibitor of protein-1 (SGLT-1) and sodium-glucose cotransporter-2 (SGLT-2).Among them, SGLT-1 is mainly responsible for glucose absorption in the gastrointestinal tract, and SGLT-2 is mainly responsible for glucose reabsorption in the kidney.Similar to the refusal of englitazone mentioned above, the reason why soglitazone was rejected by the FDA for T1DM treatment is that compared with insulin alone, the combination of such drugs with insulin may cause diabetic ketones.Increased risk of acidosis.7 The US FDA awarded the “breakthrough equipment certification” to the personalized insulin pump system. The “personalized insulin pump system” is mainly used for automatic insulin delivery.Manufacturers believe that this personalized closed-loop technology can realize automatic insulin delivery in a real-time and more adaptive manner, while also providing patients with unique predictive diagnosis, which can greatly simplify diabetes management operations.The FDA granted its “breakthrough device certification”, which shows that this device has great potential on the one hand, and also provides priority approval for device development and clinical trial certification.8 The first nasal administration of glucagon powder for severe hypoglycemia is approved by the FDA. Hypoglycemia is a common complication in diabetic patients, and severe hypoglycemia may be life-threatening. Patients with previous severe hypoglycemia need to receive pancreas as soon as possible.Glucagon injection treatment, obviously this method is not easy to obtain for some patients.In July 2019, the United States FDA approved the first glucagon powder for nasal administration. Studies have confirmed that this glucagon powder for nasal administration can work well for the treatment of severe hypoglycemia, and the wayRelative injection is more simple and easy to operate.9 POINEER 8 study: Insulin combined with oral somaglutide significantly reduced HbA1c and body weight in patients with poor glycemic control T2DM.
In October 2019, the results of the PIONEER 8 study were published online at Diabetes Care.This is a 52-week double-blind trial.731 T2DM patients treated with insulin but with poor glycemic control (with / without metformin) were randomly divided into 4 groups, the 3 mg oral somaglutide group (N = 184) and the 7 mg oral somaglutide group(N = 182), 14 mg oral somaglutide group (N = 181), and placebo group (N = 184). The study endpoints were changes in HbA1c and body weight at 26 and 52 weeks.The results showed that at 26 weeks and 52 weeks, the three groups of oral somaglutide group were significantly better than the placebo group in terms of HbA1c and weight loss.The above content is only authorized by 39Health.com for exclusive use, please do not reprint without authorization of the copyright party.

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