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what are the future trends in diabetes treatment?

borri pharmaceuticals (688166.sh) said that the global treatment and control of diabetes has shown a new trend, and diabetes remission has received more and more attention. the so-called remission means lowering blood sugar to a completely normal level. if blood sugar can still be maintained at a normal level after stopping medication for more than 3 months, it is considered that diabetes remission has been achieved. in order to achieve the goal of diabetes remission, from the perspective of treatment, on the one hand, hba1c needs to be reduced to a normal level, and on the other hand, the weight loss needs to be more than 10%. if both of these indicators are achieved, the patient's chance of achieving diabetes remission is greater.

this is from the response of dr. yuan jiandong, chairman of borri pharmaceuticals, to investors' questions at the investor relations event on august 27, 2024. on the previous day, on august 26, borri pharmaceuticals announced that its independently developed bgm0504 injection for the treatment of type 2 diabetes had achieved the expected results in its phase ii clinical trial.

among them, borrui pharmaceuticals' announcement showed that at the 12th week of target dose administration, bgm0504 injection had a significant advantage in the hba1c/body weight composite achievement rate, with 27.3% and 41.7% of the subjects in the 10mg and 15mg groups, respectively, achieving hba1c < 6.5% and a body weight reduction of ≥ 10% relative to baseline after using bgm0504 injection, while the semaglutide injection group (1.0mg) was only 6.3%.

global experts push for type 2 diabetes remission

the journal "international diabetes" once published an article stating that type 2 diabetes (t2dm) is a progressive disease characterized by hyperglycemia and has always been considered to require long-term treatment with hypoglycemic drugs. however, since the american diabetes association (ada) issued a consensus in august 2021 to clearly define "diabetes remission", t2dm remission has become a hot topic of discussion in the field of diabetes in recent years.

the 2021 ada consensus report: definition and interpretation of remission in type 2 diabetes recommends that glycated hemoglobin (hba1c) <6.5% be used as the standard for t2dm remission after patients stop taking hypoglycemic drugs for at least 3 months. however, in cases where hba1c testing is not applicable or hba1c testing is not standardized, fasting blood glucose <7.0 mmol/l or hba1c <6.5% estimated by continuous glucose monitoring (cgm) can be used as an alternative standard for t2dm remission.

in 2022, my country, led by professor ji linong, professor zou dajin, and professor zhang zheng, organized domestic experts to draft and write the "chinese expert consensus on remission of type 2 diabetes". its definition of diabetes remission also adopted the 2021 american diabetes association (ada)'s "definition and interpretation of remission of type 2 diabetes".

obese/overweight t2dm patients can achieve clinical remission through intensive lifestyle and drug therapy (including intensive insulin therapy and oral hypoglycemic drugs) and metabolic surgery, especially t2dm patients with a short disease course (disease course <5 years) and well-preserved islet function. due to glucotoxicity, the pancreatic beta cells enter a dedifferentiated "dormant" state. at this time, through active intensive hypoglycemic treatments such as insulin, the dormant pancreatic beta cells can be repaired and awakened into normal beta cells that secrete insulin.

in 2022, a british study published at the annual meeting of the european diabetes association showed that even for patients with type 2 diabetes who are not obese or overweight, their diabetes will be relieved if they lose 10% of their weight.

in march this year, the lancet diabetes & endocrinology, a subsidiary of the lancet, published the 5-year follow-up results of the direct trial. the results showed that weight management may help delay or avoid the occurrence of clinical complications of diabetes. the latest research results of direct also reaffirmed that weight loss is extremely important for the management of type 2 diabetes. on the one hand, the remission period of some patients can be maintained for at least five years; but as the weight rebounds, diabetes may reappear.

in addition, although not all patients can achieve diabetes remission through diet intervention alone, new glucose-lowering drugs (such as glucagon-like polypeptide-1 [glp-1] receptor agonists) are expected to provide more effective options for weight management in these patients. the combination of the weight management strategy in the direct study and these new glucose-lowering drugs is expected to further reduce the disease burden of patients with type 2 diabetes in the future.

bgm0504 phase ii clinical trial data has reached diabetes remission indicators

the hba1c/weight composite compliance rate is an important indicator for evaluating blood sugar control and weight management in patients with type 2 diabetes. in the phase ii clinical trial of bgm0504 injection conducted by borri pharmaceuticals, the drug showed significant effects in lowering hba1c levels and reducing weight.

dr. xie daosheng, head of clinical cro medicine, said that 27.3% of the subjects in the 10mg bgm0504 injection group reached normal glycation levels (hba1c <5.7%) 12 weeks after reaching the target dose, and 50% of the subjects in the 15mg group reached normal glycation levels, while the proportion of semaglutide was 12.5%. in addition, eli lilly's surpass study data of telportolide showed that the proportion of normal glycation levels in its 10mg and 15mg groups was 40%-50% at 40 weeks of administration.

in addition to blood sugar control, changes in weight are another indicator of concern for diabetic patients. at the 12th week of target dose administration, in terms of the hba1c/weight composite achievement rate, 27.3% of the subjects in the bgm0504 injection 10mg group achieved a reduction in hba1c to below 6.5% and at the same time, the patient's weight decreased by more than 10% relative to the baseline, and 41.7% of the patients in the 15mg group reached this level, while the proportion of semaglutide was 6.3%. clinically, a 5% weight loss is the basis for clinical benefit, and a weight loss of more than 7%-10% on this basis will enable patients to obtain better benefits in the future.

in the glucose-lowering study of tebuconazole, the average weight loss in patients with type 2 diabetes was about 7%-9%. if the bmi condition is set higher, it may exceed 10%-11%.

the characteristic of glp-1 preparations is that their glucose-lowering effect gradually decreases with the extension of administration time, especially when the target dose is reached at the 24th week, a certain degree of decrease can still be seen, and the subsequent decrease level tends to be stable. dr. xie daosheng said that since the company's phase ii clinical trial only lasted for 14 to 18 weeks for each dose group, the performance of its glycated level over a longer period in the subsequent phase iii clinical trial remains to be observed.

currently, according to the results of the phase ii clinical trial of bgm0504 injection for the treatment of type 2 diabetes, bgm0504 has an excellent hba1c/body weight composite compliance rate, which is in line with the trend of remission treatment for type 2 diabetes, and also makes more type 2 diabetes patients look forward to the results of its phase iii clinical trial.