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New Analysis Shows Sanofi's Soliqua® 100/33 Lowered HbA1c by More Than 2 Percent in Patients with Screening Levels Greater than 9 Percent

- All subgroups treated with Soliqua 100/33 achieved a mean HbA1c of below 7 percent after 30 weeks -

Jun 10, 2017

SAN DIEGO, June 10, 2017 /PRNewswire/ -- Sanofi announced today that Soliqua® 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL lowered mean blood sugar levels (HbA1c) by between 1.09 and 2.41 percent after 30 weeks in adults with type 2 diabetes previously treated with between 15 and 40 units of basal insulin daily. This new post-hoc analysis of data from the LixiLan-L Phase 3 study, which grouped participants by HbA1c level at screening, also showed that all subgroups reached a mean HbA1c below 7 percent during the study period.

"Lowering elevated HbA1c is an important treatment goal in people with diabetes," said Riccardo Perfetti, Vice President, Head of Global Medical Affairs Diabetes, Sanofi. "This analysis demonstrated the substantial blood sugar lowering effect that can be achieved with Soliqua 100/33, and also its potential to help adults reach HbA1c levels below 7 percent, which is recommended as a treatment goal by bodies such as the American Diabetes Association for many adults with diabetes."1

Soliqua® 100/33, which is used in conjunction with diet and exercise, is marketed as Suliqua® in the EU.

The abstract is titled "iGlarLixi Reduces A1C to a Greater Extent Than Basal Insulin Therapy Regardless of A1C Levels at Screening" (Niemoeller E et al. Poster presentation 1079-P, American Diabetes Association (ADA) 77th Scientific Sessions, San Diego, CA, U.S., June 10).

Summary of analysis
This post-hoc analysis reviewed data from the LixiLan-L pivotal Phase 3 trial, which compared the effectiveness of Soliqua 100/33 and insulin glargine 100 Units/mL in 736 adults whose type 2 diabetes was not adequately controlled at screening on between 15 and 40 units of basal insulin daily, alone or combined with one or two oral anti-diabetic agents. The primary outcome of the LixiLan-L study, a statistically significant reduction in HbA1c compared with insulin glargine 100 Units/mL, was previously reported.2

The analysis evaluated data for the 660 participants who completed the 30 week study period. Patients were split in three categories based on HbA1c at screening: HbA1c ≤8%, HbA1c >8% to ≤9%, and HbA1c >9%. Change from screening to study end was determined with ANOVA analysis of 30-week completers in the modified intention-to-treat (mITT) population. Least Squares (LS) mean reductions in HbA1c for the Soliqua 100/33 treatment groups after 30 weeks were 1.09%, 1.44% and 2.41%, respectively. The mean HbA1c observed for each subgroup was ≤7% with Soliqua 100/33 (6.65%, 6.99% and 6.97% respectively), but >7% with insulin glargine 100 Units/mL alone (7.22%, 7.42% and 7.66%, respectively). Reductions in HbA1c were greater for Soliqua 100/33 in all defined categories versus insulin glargine 100 Units/mL (p<0.0001 for all comparisons).

As previously reported for LixiLan-L,2 incidence of documented (≤70 mg/dL / 3.9 mmol/L) symptomatic hypoglycemia was similar with Soliqua 100/33 (40% of patients; 3.0 events/year; E/Y) and insulin glargine 100 Units/mL (42.5% of patients; 4.2 E/Y). With Soliqua 100/33, 10.4% of participants experienced nausea, and 3.6% experienced vomiting; while with insulin glargine 100 Units/mL 0.5% of participants experienced nausea and 0.5% experienced vomiting.

What is SOLIQUA® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL?

SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or lixisenatide.

  • It has not been studied in people with a history of pancreatitis.
  • It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.
  • It is not for use in people with type 1diabetes, diabetic ketoacidosis, or who have a stomach problem that causes slow emptying (gastroparesis).
  • It has not been studied together with short-acting insulin.
  • It is not known if SOLIQUA 100/33 is safe and effective in children under 18 years of age.

Important Safety Information for SOLIQUA® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL

What is the most important information I should know about SOLIQUA 100/33?

Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed.

SOLIQUA 100/33 can cause serious side effects, including inflammation of the pancreas, which may be life-threatening.

Before using SOLIQUA 100/33, tell your doctor if you have had:

  • pancreatitis
  • stones in your gallbladder (cholelithiasis)
  • a history of alcoholism

These medical problems may make you more likely to get pancreatitis. Stop taking SOLIQUA 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.

Who should not use SOLIQUA 100/33?

Do not use SOLIQUA 100/33 if you are having an episode of low blood sugar (hypoglycemia) or if you are allergic to insulin glargine, lixisenatide, or any of the other ingredients in SOLIQUA 100/33.

Tell your healthcare provider about all your medical conditions, including if you:

  • have or have had symptoms of acute pancreatitis, stones in your gallbladder, or a history of alcoholism.
  • have or have had liver or kidney problems.
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs (thiazolidinediones).
  • have severe problems with your stomach, such as slowed emptying of your stomach or problems digesting food.
  • are pregnant or plan to become pregnant. It is not known if SOLIQUA 100/33 will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOLIQUA 100/33 passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may affect the way some medicines work.

How should I use SOLIQUA 100/33?

  • Do not change your dose unless your healthcare provider has told you to change your dose.
  • Check the pen label each time you inject to make sure you are using the correct medicine.
  • Do not take more than 60 units of SOLIQUA 100/33 each day. If you take too much, it can cause severe nausea and vomiting. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists. If you take too much SOLIQUA 100/33, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Only use SOLIQUA 100/33 that is clear, colorless to almost colorless. If you see small particles, return it to your pharmacy for replacement.
  • Do not mix SOLIQUA 100/33 in any other type of insulin or liquid medicine prior to injection.
  • Do not remove SOLIQUA 100/33 from the pen with a syringe.
  • Do not re-use or share needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check.

SOLIQUA 100/33 may cause serious side effects, including:

  • Serious allergic reactions. Severe allergic reactions can happen with SOLIQUA 100/33. Stop taking it and get help right away if you have any symptoms which may include swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy and very rapid heartbeat.
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include:
    • headache
    • weakness
    • fast heartbeat
    • dizziness
    • irritability
    • feeling jittery
    • drowsiness
    • hunger
    • confusion
    • sweating
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may worsen kidney problems.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with SOLIQUA 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with SOLIQUA 100/33. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, sudden weight gain.

The most common side effects of SOLIQUA 100/33 may include:

  • low blood sugar (hypoglycemia)
  • nausea
  • headache
  • stuffy or runny nose and sore throat
  • allergic reactions
  • diarrhea
  • upper respiratory tract infection

Nausea and diarrhea usually happen more often when you start using SOLIQUA 100/33.

Please click here for full Prescribing Information for SOLIQUA 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL: www.soliqua100-33.com.

About Sanofi Diabetes & Cardiovascular 
Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care. 

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Reference
1. American Diabetes Association, Diabetes Care Jan 2017, 40 (Supplement 1) S48-S56; DOI: 10.2337/dc17-S009.
2. Aroda VR, et al. Diabetes Care. 2016, DOI: 10.2337/dc16-1495.

Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the clinical development of and potential marketing approvals for the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", "will be" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development of the product, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

SOURCE Sanofi

For further information: U.S. Media Relations, Ashleigh Koss, Tel: +1 (908) 981-8745, ashleigh.koss@sanofi.com; Investor Relations, George Grofik, Tel.: +33 (0)1 53 77 45 45, ir@sanofi.com; U.S. Diabetes Communications, Susan Brooks, Tel.: +1 (908) 981 6566, susan.brooks@sanofi.com

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