- On June 1, Lilly China announced that the instruction manual of duyida ® (dulaglutide), a weekly preparation of GLP-1 (glucagon like peptide-1) receptor agonist, was updated and approved by the State Drug Administration.
- This is another significant progress and important supplement after dulaglutide was approved for marketing in China in February last year for the blood glucose control of adult type 2 diabetic patients.
- Therefore, at present, in addition to the regular demand for lowering blood sugar, diabetes treatment also needs to pay attention to the hypoglycemic drugs that can reduce or delay the macroangiopathy.
- After the blockbuster results of rewind research were published on ADA in 2019, the EU instruction manual of duyida (dulaglycopeptide) was updated rapidly in September of the same year, and the FDA approved the update of the EU instruction manual in February of this year.
- About rewind research
- Shengnuo Biotechnology is a high-tech China polypeptide manufacturers,who has over 19 years experience for the biotechnology .Our Products involve peptide raw materials,polypeptide drug.
On June 1, Lilly China announced that the instruction manual of duyida ® (dulaglutide), a weekly preparation of GLP-1 (glucagon like peptide-1) receptor agonist, was updated and approved by the State Drug Administration.
According to the latest instruction: duyida ® (Dula glycopeptide) is suitable for blood glucose control in adult type 2 diabetes patients, and it can reduce major cardiovascular adverse events (MACE) regardless of whether the patients have been diagnosed with cardiovascular disease (CVD) or have multiple cardiovascular risk factors.
This manual update is based on the results of rewind study (cardiovascular outcome study of dulaglutide). The update progress of the results is Yida (dulaglutide) China manual, which provides sufficient clinical evidence for its use in the treatment of adult type 2 diabetes mellitus with CVD or multiple cardiovascular risk factors, and the reduction of major cardiovascular adverse events. It means that in the widely recognized hypoglycemic effect and the advantages of simple injection device and experience, dulaglutide can also help patients with type 2 diabetes mellitus, whether cardiovascular disease is confirmed or not, can significantly reduce the incidence of major cardiovascular adverse events.
This is another significant progress and important supplement after dulaglutide was approved for marketing in China in February last year for the blood glucose control of adult type 2 diabetic patients.
The change of diabetes treatment concept: pay attention to the treatment outcome, help to reduce the complications of macrovascular and microvascular, can not only pay attention to hypoglycemia, rewind research came into being
According to statistics, the number of diabetes patients in China has reached 130 million, with one in every ten people suffering from diabetes. However, the situation of blood glucose control is not optimistic, and the rate of reaching the standard is only 15.8%.
As we all know, diabetes is not terrible, terrible is the complications, including microvascular complications and macrovascular complications. Previous clinical studies have shown that strict control of blood glucose can delay the progress of microvascular complications, but it has no significant effect on macroangiopathy. Some studies have shown that 72% of patients with type 2 diabetes have cardiovascular risk factors, and cardiovascular disease has become the primary cause of death in patients with type 2 diabetes. About half of patients with type 2 diabetes die of cardiovascular disease.
Therefore, at present, in addition to the regular demand for lowering blood sugar, diabetes treatment also needs to pay attention to the hypoglycemic drugs that can reduce or delay the macroangiopathy.
Therefore, it is particularly important to have cardiovascular benefits independent of glucose reduction.
Duyida ® (dulaglycopeptide) helps Chinese patients with type 2 diabetes improve their health outcomes
The rewind study evaluated whether doyoda ® (Dula glycopeptide) can protect T2DM patients from the first cardiovascular event and prevent future cardiovascular events in those patients with CVD. The results were published in the American Diabetes Association (ADA) in 2019, revealing the achievement of its bold and effective preset end point, and duyida ® (Dula glycopeptide) became the first hypoglycemic drug to reduce mace events in clinical trials of most subjects not diagnosed with CVD.
The unique feature of rewind study compared with other cardiovascular outcome studies is that the number of participants with confirmed CVD is limited, which can allow us to observe the cardiovascular benefits of easy access in a wide range of T2DM population. Importantly, the rewind study had a median follow-up of more than five years, the longest in the GLP-1 receptor agonist based cardiovascular outcome study. In contrast, other cardiovascular outcome studies included a higher baseline A1C and a higher proportion of patients diagnosed with CVD. Of the 9901 patients in the rewind study, the average A1C baseline was relatively low at 7.3%, and only 31% had confirmed CVD. In addition, the incidence of rewind study year is low, which proves that the risk of CVD in the included population is low, and the time needed to reach the number of events is longer, so the median follow-up time is 5.4 years. This provides a basis for the long-term safety of dulaglutide.
After the blockbuster results of rewind research were published on ADA in 2019, the EU instruction manual of duyida (dulaglycopeptide) was updated rapidly in September of the same year, and the FDA approved the update of the EU instruction manual in February of this year.
Within a short period of three months, rewind research was approved by nmpa to update the Chinese specification of doyoda ®.
In this regard, Julio gay GER, President and general manager of Lilly China, said, “based on the confirmed hypoglycemic effect and the advantages of simple injection device, duyida ® (Dula glycopeptide) is the first and only drug that can help patients with type 2 diabetes reduce the risk of cardiovascular events, whether or not it has a history of cardiovascular disease. This is particularly important because most patients with type 2 diabetes are at risk of stroke, myocardial infarction or even death from cardiovascular disease. This manual update brings hope to these patients. In the future, in order to help achieve the management objectives of “healthy China 2030” chronic diseases, especially diabetes and cardiovascular adverse events, Lilly China will continue to promote product innovation, market access and drug access, trying to benefit more Chinese patients and help them live longer and healthier. “
About rewind research
Rewind study is a multicenter, randomized, double-blind, placebo-controlled study comparing doyida ® 1.5mg (weekly glucagon like peptide 1 receptor agonist, GLP-1 RA) and placebo on cardiovascular events in adults with type 2 diabetes. The primary cardiovascular end point was the first mace (composite event of cardiovascular death or nonfatal myocardial infarction or nonfatal stroke). Secondary endpoints included components of each cardiovascular event in the primary composite endpoint, composite clinical microvascular outcomes for retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or emergency treatment, and all-cause death. 9901 subjects from 24 countries / regions had an average duration of diabetes of 10.5 years and an average baseline A1C of 7.2%. Although all subjects had cardiovascular risk factors, only 31.5% of them were diagnosed with cardiovascular disease.
In rewind, previous (or confirmed) cardiovascular diseases are defined as: previous myocardial infarction, previous ischemic stroke, previous unstable angina pectoris, previous history of revascularization (coronary artery, carotid artery or peripheral artery), previous hospitalization due to related ischemic events (unstable angina pectoris or imaging findings of myocardial ischemia, or need for percutaneous coronary intervention Treatment), or the history of myocardial ischemia has been recorded.
Rewind study is an international clinical trial, in which women account for a large proportion, the proportion of patients with undiagnosed cardiovascular disease is high, and the average baseline A1C of subjects is low, suggesting that the results of this study are more applicable to the more common type 2 diabetes patients in clinical practice.
Statement: according to the approved product instructions in China, duyida is applicable to the treatment of adult type 2 diabetes patients with single drug, combined with metformin and / or sulfonylurea. Rewind research was updated into the clinical research section of the Chinese instruction manual, which provides the basis for duyida to help patients with type 2 diabetes to gain long-term cardiovascular benefits.
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