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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-L)

ClinicalTrials.gov Identifier: NCT02058160

In this issue, we wrote about the potential for combining different classes of drugs together to increase convenience and improve outcomes. The combination of a GLP-1 receptor agonist with insulin has shown promising results, most notably with the glucose-lowering and weight-reducing benefits of Xultophy (Novo Nordisk’s combination of GLP-1 agonist liraglutide with insulin degludec). GLP-1 agonists work to simulate the production of insulin when blood sugars become too high, and are associated with improve control, potential weight loss, and little increased risk of hypoglycemia. This study from Sanofi will compare the fixed dose combination of the basal insulin Lantus and the GLP-1 agonist Lyxumia (insulin glargine/lixisenatide) vs. Lantus alone in people with type 2 diabetes. The researchers hope to demonstrate that the fixed dose combination is superior at reducing A1c compared to insulin alone.

The randomized study is expected to last 30 weeks, enrolling ~700 participants total. Participants must have had type 2 diabetes for at least one year, have been treated with basal insulin for at least six months prior to enrollment, be at least 18 years old, have an A1c between 7.5% and 10%, and a BMI between 20 and 40 kg/m2, among other criteria. Women who are potentially pregnant, people who have used weight loss drugs within the three months prior to enrollment, and people with impaired kidney function or a history of pancreatitis cannot participate. The trials will take place in the Americas, Europe, and Australia, with several study sites in the United States (AL, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, KY, ME, MD, MI, MN, MT, NE, NV, NM, NC, OH, OR, PA, SC, SD, TX, UT, VT, VA, WA, and WI). For more information, please visit the ClinicalTrials.gov website or e-mail contact-us@sanofi.com. - AJW

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