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    Home > Active Ingredient News > Endocrine System > Blockbuster | The latest clinical research results of the innovative diabetes drug SOLIQUA™ (iGlarLixi) are released!

    Blockbuster | The latest clinical research results of the innovative diabetes drug SOLIQUA™ (iGlarLixi) are released!

    • Last Update: 2022-06-10
    • Source: Internet
    • Author: User
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    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 endpoint of the study.
    Another major release after L CN

    .

    Professor Yang Wenying, principal investigator of LixiLan-O AP, Department of Endocrinology, China-Japan Friendship Hospital, according to the guidelines for the diagnosis and treatment of diabetes at home and abroad, recommends that patients with type 2 diabetes who have not achieved optimal blood sugar control after receiving first-line oral hypoglycemic drugs such as metformin, can Choose to start basal insulin and GLP-1RA combination therapy
    .

    The results of this trial also confirm that such patients can benefit from iGlarLixi, a cutting-edge therapy
    .

    iGlarLixi, which only needs to be injected once a day, has better efficacy and safety in the Chinese population.
    We are looking forward to the launch of iGlarLixi, an innovative therapy, to bring new hope to the majority of Chinese diabetic patients

    .

    LixiLan-O AP is an open-label, active-controlled, 24-week clinical trial comparing 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
    .

    A total of 878 adult subjects from the Asia-Pacific region were enrolled in this trial, of which 86.
    3% were from mainland China

    .

    Subjects were randomly assigned to iGlarLixi, basal insulin, or GLP-1RA in a 2:2:1 ratio.
    ) to initiate treatment

    .

    The results of the study confirmed that iGlarLixi has excellent hypoglycemic effect and a higher percentage of reaching the target: at 24 weeks of treatment, the average glycated hemoglobin (HbA1c) of the subjects in the iGlarLixi group reached 6.
    3%, which was significantly better than the basal insulin group and GLP-1RA group.
    The improvement in blood glucose 2 hours after a meal was significantly better

    .

    In addition, the SMBG of the iGlarLixi group was significantly improved, and the blood glucose values ​​at 7 points after treatment all achieved the preprandial (4.
    4-7.
    0 mmol/L) and postprandial standard values ​​(<10.
    0 mmol) recommended by the "China Guidelines for the Prevention and Treatment of Type 2 Diabetes" (CDS Guidelines).
    /L)

    .

    At the same time, 79% of subjects in the iGlarLixi group achieved HbA1c after treatment
    .

    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 stepwise titration, gastrointestinal adverse events occurred in the iGlarLixi group The rate was lower than that of GLP-1RA group
    .

    Dr.
    Gu Chengming Head of Sanofi Greater China Medical Department As the country with the largest number of diabetic patients in the world [1], China has huge unmet needs in the field of diabetes

    .

    About 50% of patients report fasting hyperglycemia and/or postprandial hyperglycemia[2].
    The potential risk of hypoglycemia and multiple injection therapy are also one of the main reasons for the insufficient insulin initiation rate and poor compliance of Chinese patients.

    .

    And iGlarLixi can effectively solve these pain points of patients
    .

    The Phase III clinical trial of iGlarLixi will be the last clinical trial of this innovative drug before it is approved for marketing.
    We are very pleased to see that on the basis of SoliMix’s global research and LixiLan-L’s research in China, it has once again achieved in the Asia-Pacific experimental research.
    Positive progress, further demonstrating iGlarLixi's excellent efficacy and stable safety profile in patient populations poorly controlled by oral medications

    .

    We look forward to this drug helping more Chinese patients to rejuvenate their lives as soon as possible
    .

    In addition, in January 2022, China's National Medical Products Administration (NMPA) approved the world's first head-to-head clinical trial of iGlarLixi and insulin degludec, which is the first clinical trial following the SoliMix study (comparing biphasic insulin aspart 30).
    A head-to-head trial with premixed insulin for which the (first) investigator meeting is expected in May

    .

    Domestic endocrinology experts and scholars will explore more clinical evidence-based medical evidence about iGlarLixi, bringing good news to many Chinese diabetic patients
    .

    More about iGlarLixi China's National Medical Products Administration (NMPA) has officially accepted iGlarLixi's new drug marketing application on September 28, 2021, and looks forward to bringing new hypoglycemic options to Chinese diabetic patients as soon as possible
    .

    The LixiLan series of global studies published its trial results in different populations from 2015 to 2018 to demonstrate that it can provide poor control of oral medication, poor control of basal insulin and poor control of GLP-1 RA.
    Excellent blood sugar control with safety in mind

    .

    Results of the SoliMix Global Study to be presented at the American Diabetes Association Annual Meeting (ADA) in June 2021 - the world's first head-to-head study of iGlarLixi and premixed insulin (Biphasic Aspart 30, BIAsp 30), which included Basal insulin combined with 1-2 kinds of oral hypoglycemic drugs was used to treat T2DM with poor blood sugar control, and they were divided into iGlarLixi treatment group and premixed insulin treatment group
    .

    The results showed that the proportion of patients treated with iGlarLixi who achieved HbA1c target without weight gain and/or hypoglycemia was higher than the premixed insulin group
    .

    Chinese Phase III study LixiLan-L CN to announce results at the European Association for the Study of Diabetes (EASD) in October 2021 - the first Chinese Phase III study to evaluate switching to iGlarLixi in Chinese T2DM population with poor basal insulin control The efficacy and safety of the study met the prespecified primary endpoint, iGlarLixi improved glycation better than basal insulin
    .

    *SOLIQUA™ (iGlarLixi) has not yet been approved in China References[1] International Diabetes Federation: IDF Diabetes Atlas, 9th Edition.
    2019;[2] Xu Y, et al.
    JAMA 2013;310:948–59 Typesetting: edited by Lingling Huang : Huang Lingling Review: Qiu Jia
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