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.
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:
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:
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?
SOLIQUA 100/33 may cause serious side effects, including:
The most common side effects of SOLIQUA 100/33 may include:
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.
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).
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.
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