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On April 21 , 2022 , Sanofi China announced that its clinical study LixiLan -O AP , a fixed-ratio combination of basal insulin and GLP-1RA in the Asia-Pacific region, SOLIQUA™ (iGlarLixi)* , met the primary study endpoint, which is also the Another major release following the Chinese Phase III study LixiLan-L CN .
On April 21 , 2022 , Sanofi China announced that its clinical study LixiLan -O AP , a fixed-ratio combination of basal insulin and GLP-1RA in the Asia-Pacific region, SOLIQUA™ (iGlarLixi)* , met the primary study endpoint, which is also the Another major release following the Chinese Phase III study LixiLan-L CN .
Professor Yang Wenying from the Department of Endocrinology, China-Japan Friendship Hospital, the principal investigator of LixiLan-O AP , said: " According to the guidelines for the diagnosis and treatment of diabetes at home and abroad, for patients with type 2 diabetes who have not achieved optimal blood sugar control after receiving first-line oral hypoglycemic drugs such as metformin Patients can choose to start basal insulin and GLP-1RA combination therapy .
LixiLan-O AP is an open-label, active-controlled, 24 - week clinical trial to compare iGlarLixi with basal insulin or GLP-1RA in patients already receiving metformin with or without a second oral hypoglycemic agent Efficacy and safety in poorly controlled patients with type 2 diabetes mellitus ( T2DM ) in Asia Pacific .
The results of the study confirmed: The results of the study confirmed that:
iGlarLixi has excellent hypoglycemic effect, and the proportion of reaching the target is higher: at 24 weeks of treatment, the average glycated hemoglobin ( HbA1c ) of the subjects in the iGlarLixi group reached 6.
iGlarLixi has excellent hypoglycemic effect, and the proportion of reaching the target is higher: at 24 weeks of treatment, the average glycated hemoglobin ( HbA1c ) of the subjects in the iGlarLixi group reached 6.
iGlarLixi has a better safety profile: During the 24 - week treatment period, the incidence of hypoglycemia in the iGlarLixi group was similar to that in the basal insulin group, the mean body weight of the subjects remained almost unchanged, and due to the use of stepwise titration, gastrointestinal adverse events occurred in the iGlarLixi group.
“ As the country with the largest number of diabetic patients in the world, China has a huge unmet need in the field of diabetes
In addition, in January 2022 , China's National Medical Products Administration ( NMPA ) approved the world's first head-to-head clinical trial of iGlarLixi versus insulin degludec, which follows the SoliMix study (comparingbiphasic insulin aspart 30)A head-to-head trial with premixed insulin for which the (first) investigator meeting is expected in May .
It is reported that China's National Medical Products Administration ( NMPA ) has officially accepted the new drug marketing application of iGlarLixi on September 28 , 2021 , and looks forward to bringing a new hypoglycemic option to Chinese diabetic patients as soon as possible .
LixiLan series of global studies: Published its trial results in different populations from 2015 to 2018 to prove that it can be effective in people with poor control of oral medication, poor control of basal insulin and poor control of GLP-1 RAProvides excellent blood sugar control with safety in mind .
SoliMix Global Study: Results to be presented at the American Diabetes Association Annual Meeting ( ADA ) in June 2021 - the world's first head-to-head study of iGlarLixi with premixed insulin (Biphasic Aspart 30 , BIAsp 30 ), which included The patients with T2DM with poor blood sugar control were treated with basal insulin combined with 1-2 kinds of oral hypoglycemic drugs , and they were divided into iGlarLixi treatment group and premixed insulin treatment group .
Chinese Phase III study LixiLan-L CN : Results to be presented at the European Association for the Study of Diabetes ( EASD ) in October 2021 - the first Chinese Phase III study to evaluate switching in a Chinese T2DM population with poor basal insulin control The efficacy and safety of iGlarLixi , the study met the prespecified primary endpoint, iGlarLixi improved glycation better than basal insulin .
*SOLIQUA™ (iGlarLixi) not yet approved in China *SOLIQUA™ (iGlarLixi) not yet approved in China
References
References1.
1 , International Diabetes Federation: IDF Diabetes Atlas, 9th Edition.
2 , Xu Y, et al.
JAMA 2013;310:948–59 2 , Xu Y, et al.
JAMA 2013;310:948–59
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