The latest clinical research results of the innovative diabetes drug iGlarLixi (basal insulin GLP-1RA compound preparation) are released!

*For medical professionals only, April 21, 2022, Shanghai, China – Sanofi China announced that its basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA) trials in Asia Pacific The clinical study LixiLan-O AP of the fixed-ratio compound iGlarLixi achieved the primary endpoint of the study, which is another major release following the Phase III study LixiLan-L CN in China
.

 Professor Yang Wenying, LixiLan-O AP principal investigator, Professor Yang Wenying, Department of Endocrinology, China-Japan Friendship Hospital, said: "According to domestic and foreign guidelines for the diagnosis and treatment of diabetes, for patients who have not achieved optimal blood sugar control after receiving first-line oral hypoglycemic drugs such as metformin, 2 Type 2 diabetes mellitus (T2DM) patients can choose to start basal insulin and GLP-1RA combination therapy
.

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

Only daily injections are required.
The one-time iGlarLixi has better efficacy and safety in the Chinese population, and we are very much 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 drug A controlled, 24-week clinical trial to compare the efficacy and efficacy of iGlarLixi with basal insulin or GLP-1RA in T2DM in Asia-Pacific with poor glycemic control after treatment with metformin with or without a second oral hypoglycemic agent security
.

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, with 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.
, 2 hours postprandial blood glucose improvement was significantly better
.

In addition, the self-monitoring of blood glucose (SMBG) in the iGlarLixi group was significantly improved, and the blood glucose values ​​at 7 points after treatment all achieved the pre-prandial (4.
4-7.
0 mmol/L) and postprandial (4.
4-7.
0 mmol/L) and postprandial ( <10.
0 mmol/L standard value)
.

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
.

“As the country with the largest number of diabetic patients in the world, China has a huge unmet need in the field of diabetes
.

About 50% of patients report fasting hyperglycemia and/or postprandial hyperglycemia, and the potential risk of hypoglycemia is related to Multi-acupuncture treatment is also one of the main reasons why Chinese patients have insufficient insulin initiation rate and poor compliance
.

iGlarLixi can effectively solve these pain points for patients
.

Dr.
Gu Chengming, Head of Sanofi Greater China Medical Department, said, "The phase III clinical trial of iGlarLixi will be the last clinical trial before the innovative drug is approved for marketing.
We are very pleased to see the global research of SoliMix and LixiLan On the basis of the -L China study, positive progress was made again in the Asia-Pacific pilot study, which further proved the excellent efficacy and stable safety of iGlarLixi in the patient population with poor oral drug control
.

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 biphasic insulin aspart following the SoliMix study (comparing biphasic insulin aspart 30) A head-to-head trial with soluble double insulin, the (first) investigator meeting of the trial is expected to be held in May
.

Experts and scholars in the domestic endocrinology field will explore more clinical evidence-based medicine about iGlarLixi, and help many Chinese diabetic patients.
Good news
.

 More about iGlarLixiNMPA has officially accepted the new drug marketing application of iGlarLixi on September 28, 2021, and looks forward to bringing new hypoglycemic options to Chinese diabetic patients as soon as possible
.

 LixiLan series of global studies: to be announced in succession from 2015 to 2018 The results of its trials in different populations demonstrate that it can provide ideal glycemic control in people with poor oral medication control, poor basal insulin control, and poor control of GLP-1RA, while taking into account safety
.

SoliMix Global Study: Results to be presented at the American Diabetes Association (ADA) Annual Meeting in June 2021 - the world's first head-to-head study of iGlarLixi and premixed insulin (Biphasic Aspart 30, BIAsp 30), which included Patients with T2DM with poor blood sugar control were treated with basal insulin combined with 1-2 oral hypoglycemic drugs, and 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: Results to be announced at the European Association for the Study of Diabetes (EASD) in October 2021 - the first Chinese Phase III study to evaluate switching in Chinese T2DM population with poor basal insulin control The efficacy and safety of iGlarLixi, the study met the prespecified primary endpoint, iGlarLixi improved HbA1c better than basal insulin
.

*iGlarLixi has not been approved for Sanofi in China Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended
.

Forward-looking statements are not statements of historical fact
.

These statements include projections and estimates of the product's marketing and other potential, or projections and estimates of the product's potential future revenue
.

Words such as "expect," "anticipate," "believe," "intend," "estimate," "plan" and similar expressions can generally be used to identify forward-looking statements
.

Although Sanofi management believes that the expectations reflected in this forward-looking statement are reasonable, investors are cautioned that such forward-looking information and statements are subject to a number of risks and uncertainties, many of which are difficult to predict and generally not controlled by Sanofi, which could cause actual results and developments to differ materially from those expressed, implied or predicted in forward-looking information and statements
.

These risks and uncertainties primarily include, among other things, decisions or delays by regulatory authorities, or decisions of relevant agencies on matters that may affect the availability or commercial potential of the product candidate, the likelihood that an approved product candidate will not be commercially successful , including uncertainties inherent in research and development, future clinical data and analyses, including data obtained and analyses performed after products are marketed, unanticipated safety, quality or manufacturing issues, general competition, intellectual property related risks related to future litigation and the eventual outcome of such litigation, as well as fluctuating economic and market conditions, including the impact the COVID-19 pandemic will have on the financial condition of us, customers, suppliers and other business partners, and either party, and Including the impact on our employees and the global economy
.

The significant impact of Covid-19 on any of the above parties may also negatively affect us
.

This situation is changing rapidly and may have additional impacts that we are currently unaware of and exacerbate other previously identified risks
.

These risks and uncertainties also include those that have been discussed or identified in Sanofi's public reports to the Securities and Exchange Commission (SEC) and the French Financial Markets Authority (AMF), including those listed on Form 20-F "Risk Factors" and "Forward-Looking Statement Cautionary" in Sanofi's Annual Report (as of December 31, 2020)
.

Sanofi undertakes no obligation to update or revise any forward-looking information and statements, except as required by applicable law
.

 -End-MAT-CN-22070730, valid on April 14, 2024.
The serial number is only used as Sanofi's confirmation of the authenticity of the scientific and clinical data sources in the therapeutic areas of the Sanofi-related drugs involved in this article, and not as Sanofi's Confirmation and guarantee for the accuracy, timeliness and completeness of the entire content of this article; this article is only used by medical and health professionals for the purpose of academic communication or understanding of medical information, and does not constitute a recommendation or promotion of any drug or treatment plan
.

The information contained in this article should not be used as a substitute for medical advice from a healthcare professional
.

"This article is only used to provide scientific information to medical and health professionals, and does not represent the platform's position.
" For contributions/reprints/business cooperation, please contact: pengsanmei@yxj.
org.
cn