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Sanofi's Soliqua® 100/33 Provided Earlier Blood Sugar Control than Insulin Glargine 100 Units/mL

-- More adults reached HbA(1c) target at 8 and 12 weeks versus those receiving insulin glargine 100 Units/mL --

Sep 12, 2017

LISBON, Portugal, Sept. 12, 2017 /PRNewswire/ -- In certain adults with type 2 diabetes, Sanofi's Soliqua® 100/33 (insulin glargine & lixisenatide injection, 100 Units/mL & 33 mcg/mL) provided blood sugar control earlier and in more adults than those treated with insulin glargine 100 Units/mL alone, according to a new post-hoc analysis of key late-stage clinical trials.

"Reaching an HbA1c target quickly can have a benefit for adults with type 2 diabetes," said Dr. Juan Frias, President and Principal Investigator of the National Research Institute in Los Angeles, California, U.S. "Early, effective glycemic control can lead to better outcomes, both clinically and in terms of the overall cost of care."

The analysis was presented today at the European Association for the Study of Diabetes (EASD) 53rd Annual Meeting, in Lisbon, Portugal. The abstract is titled "Shorter time to glycaemic control with fixed-ratio combination of insulin glargine and lixisenatide compared with insulin glargine treatment alone" (Frias J.P. et al. Poster presentation #803). 

Summary of analysis 
This post-hoc analysis reviewed data from the Phase 3 trials, LixiLan-O and LixiLan-L,1,2 which compared the effectiveness of Soliqua 100/33 vs. insulin glargine 100 Units/mL on top of metformin (if previously taken) in more than 1,900 adults with type 2 diabetes (LixiLan-O n=1,170 and LixiLan-L n=736). Primary results and safety information for both studies were previously reported.1,2 Blood glucose levels were evaluated at 8 and 12 weeks, and the Kaplan-Meier method was used to estimate time to control, defined as time (days) to first achieve an HbA1c of less than 7 percent or fasting plasma glucose (FPG) of less than or equal to 7.2 mmol/L (130 mg/dL).

Table. Achievement of glycemic control targets in the LixiLan-O and LixiLan-L trials (safety population)


iGlarLixi

iGlar


iGlarLixi

iGlar

LixiLan-O*

N=469

N=467

LixiLan-L*

N=365

N=365

HbA1c <7%



HbA1c <7%



    Patients achieving target, n (%)



    Patients achieving target, n (%)



       n

468

466

       n

366

365

       At 8 weeks

186 (39.7)

128 (27.5)

       At 8 weeks

116 (31.7)

73 (20.0)

       At 12 weeks

279 (59.6)

209 (44.8)

       At 12 weeks

168 (45.9)

87 (23.8)

    Days to first HbA1c <7%, median

85.0

166.0

    Days to first HbA1c <7%, median

153.0

NR

      HR (95% CI)§

1.5 (1.3, 1.7)

      HR (95% CI)§

2.0 (1.7, 2.5)

      p-value

<0.0001

      p-value

<0.0001

FPG ≤7.2 mmol/L


FPG ≤7.2 mmol/L



    Days to first FPG ≤7.2 mmol/L,
median

56.0

57.0

    Days to first FPG ≤7.2 mmol/L,
median

1.0

1.0

      HR (95% CI)§

1.1 (1.0, 1.2)

      HR (95% CI)§

0.9 (0.8, 1.1)

      p-value

0.2134

      p-value

0.2137









*In both LixiLan-O and LixiLan-L, drug titrations were based on the same algorithm.

Responder analysis based on the mITT population: estimated by proportion of patients achieving targets at Weeks 8 and 12. Median time to control: defined as 50% of patients reaching target as estimated by the Kaplan-Meier method. §Estimated using Cox regression model with treatment as the only factor. Calculated using the log-rank test. FPG, fasting plasma glucose; mITT, modified intent-to-treat; NR, not reached (i.e. target no reached by 50% of patients).

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

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, or 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 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 problems with your pancreas, your kidneys, or your liver, stones in your gallbladder, or a history of alcoholism.
  • 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 breastfeeding or plan to become pregnant or to breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn baby or pass 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. Before using SOLIQUA 100/33, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use SOLIQUA 100/33?

  • Do not change your dose without first talking to your healthcare provider.
  • 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. Do not take SOLIQUA 100/33 with other GLP-1 receptor agonists.
  • 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 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. Stop taking SOLIQUA 100/33 and get help right away if you have any symptoms of a serious allergic reaction, including 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, dizziness, drowsiness, confusion, weakness, irritability, hunger, sweating, fast heartbeat, and feeling jittery.
  • 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), stuffy or runny nose and sore throat, upper respiratory tract infection, headache, allergic reactions, nausea, and diarrhea. 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).

Sanofi 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.

References

  1. Aroda VR, et al. Diabetes Care. 2016, DOI: 10.2337/dc16-1495. 
  2. Rosenstock J. et al. Diabetes Care Aug 2016, dc160917; DOI: 10.2337/dc16-0917.

SOURCE Sanofi

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

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